Sugiyama-Badr Laboratory

Pharma PSE

Pharmaceuticals are life-saving industrial products. Conventionally, the mainstream medications consisted of small molecules made by chemical synthesis, but in recent years the market share of biopharmaceuticals such as monoclonal antibodies has expanded at a rapid pace. Recent new developments include gene therapy and its commercialization, as well as clinical trials of induced pluripotent stem cells (iPSCs). New methodologies that can support advanced pharmaceutical manufacturing are needed.
　

We are conducting research on pharmaceutical PSE (Pharma PSE). This is a new field that deals with modeling, simulation, and optimization, to support decision-making in drug manufacturing. We aim at multiscale research that cannot be achieved solely by a monoscale study, by being aware of the connections among molecules and cells, processes, and the healthcare society. We are working on the following topics using both simulation and experimental approaches.

Research theme and approach

　Small molecules

Small molecules are the most popular drugs made by chemical synthesis and are usually provided in solid dosage forms, e.g., tablets and capsules. In this field, flow chemistry and continuous manufacturing are actively studied, and new approaches to process design are needed to determine the choice of batch or continuous manufacturing. For solid drug manufacturing, we have been developing a method that enables comprehensive generation of process alternatives and their economic assessment. The research outcome is being implemented by the software package called “SoliDecision”, and a prototype version is available. Regarding granulation processes, key parameters related to product quality were successfully determined through experimental investigations. We are also conducting research on drug substance synthesis and injectable drug manufacturing from the perspective of continuous and batch processes.
　
　

Key recent publications Yamada et al., "Economic Model for Lot-Size Determination in Pharmaceutical Injectable Manufacturing", J Pharm Innov, in press Matsunami et al., "Superstructure-based process synthesis and economic assessment under uncertainty for solid drug product manufacturing", BMC Chem Eng, 2, 6 (2020) Matsunami et al., "Determining key parameters of continuous wet granulation for tablet quality and productivity: A case in ethenzamide", Int J Pharm, 579, 119160 (2020) Matsunami et al., "A large-scale experimental comparison of batch and continuous technologies in pharmaceutical tablet manufacturing using ethenzamide", Int J Pharm, 559, 210–219 (2019) Matsunami et al.,"Decision support method for the choice between batch and continuous technologies in solid drug product manufacturing", Ind Eng Chem Res, 57(30), 9798–9809 (2018)
Active members


Kensaku Matsunami	Junu Kim	Masahiro Yamada	Danny Harjowinoto	Shungo Matsueda

　Biopharmaceuticals

Biopharmaceuticals are a new type of drug that contains, among other ingredients, cell-produced antibodies. The global market is rapidly expanding, and the trend is now for small-scale production of various products. Increasing efficiency of manufacturing processes, including changeover operations is becoming critical. With a focus on the manufacturing of injectables, we work on single-use equipment using disposable resins, and cleaning, sterilization, and decontamination of manufacturing equipment, and have developed design methods for efficient processes. We proposed a multi-objective evaluation method that considers economic performance, product quality, supply stability, and environment impacts. A prototype version of TECHoice, a tool for selecting equipment technology, is now available. We are also working on process design for the continuous production of antibodies, including new technologies such as perfusion cultivation and continuous chromatography purification.
　
　

Key recent publications Yabuta et al., "Impact of H₂O₂ sorption by polymers on the duration of aeration in pharmaceutical decontamination", J Pharm Sci, in press Badr and Sugiyama, "A PSE perspective for the efficient production of monoclonal antibodies: Integration of process, cell, and product design aspects", Curr Opin Chem Eng, 27, 121–128 (2020) Zeberli et al., "Approach for multicriteria equipment redesign in sterile manufacturing of biopharmaceuticals", J Pharm Innov, 15, 15–25 (2020) Shirahata et al., "Dynamic modelling, simulation and economic evaluation of two CHO cell-based production modes towards developing biopharmaceutical manufacturing processes", Chem Eng Res Des, 150, 218–233 (2019) Shirahata et al., "Multiobjective decision-support tools for the choice between single-use and multi-use technologies in sterile filling of biopharmaceuticals", Comput Chem Eng, 122, 114–128 (2019)
Active members


Sara Badr	Kozue Okamura	Nozomi Takahashi	Yuki Yoshiyama

　Regenerative medicine

Regenerative medicine is a future treatment technology using stem cells such as iPSCs. As many clinical trials are in progress, establishing the actual processes has become urgent. We design the blueprint of the processes by making full use of simulation technologies. More specifically, we investigate the process design of aseptic filling and slow freezing for iPSCs. For aseptic filling, we proposed an approach of determining lot sizes by describing the temporal change of cell quality using probability distributions. For slow freezing, we managed to develop a design guidance by simulating the relationship between the cooling rate, the degree of dehydration, and ice crystal formation. We are involved in multiscale research that deals with cells, processes, and supply chains in one framework.
　
　

Key recent publications Hayashi et al., "Slow Freezing Process Design for Human Induced Pluripotent Stem Cells by Modeling Intracontainer Variation", Comput Chem Eng, 132, 106597 (2020) Sugiyama et al., "A distribution-based approach for determining lot sizes in the filling of human-induced pluripotent stem cells", Regen Ther, 12, 94–101 (2019)
Active members


Yusuke Hayashi	Keita Hirono	Akinori Shigeyama

　Data science

In pharmaceutical processes that require strict quality control, a large number of measurement sensors are available, and electronic recording systems are in operation. The climate is ready for fully utilizing the large amounts of data obtained. We are developing methods to support process operation and improvement using data science technologies for manufacturing biopharmaceutical injectables. We proposed an approach to yield improvement based on comprehensive statistical data analyses, a cleaning method of raw data using dynamic DNA sequencing and machine learning, and a lead time improvement method using Monte Carlo simulation and global sensitivity analysis. Some of the results were implemented in an actual industrial process that was investigated in our study. We are also addressing the question of how to use “information” obtained from data as “knowledge” using chemical engineering approaches.
　
　

Key recent publications Casola et al., "Data mining algorithm for pre-processing biopharmaceutical drug product manufacturing records", Comput Chem Eng, 124, 253–269 (2019) Casola et al., "Uncertainty-conscious methodology for process performance assessment in biopharmaceutical drug product manufacturing", AIChE J, 64(4), 1272–1284 (2018) Eberle et al., "Rigorous approach to scheduling of sterile drug product manufacturing", Comput Chem Eng 94, 221–234 (2016)
Active members


Sara Badr	Anicia Zeberli	Philipp Zuercher

　Software development

We are converting academic research into tools for business practice by developing software based on research outcomes. The following prototype versions have been released to date.

SoliDecision（Click here for details）：This is a tool for comprehensive generation and economic evaluation of process alternatives in solid drug manufacturing. The input parameters can be represented as probability distributions, and thus the tool can assess the uncertainty from clinical development to commercial production.
TECHoice（Click here for details）：This is a tool for decision support between single-use and multi-use technologies in aseptic filling processes. The tool can perform multi-objective assessments on the economy, environment, quality, and supply.

Development of other software packages is also in progress. We are developing commercial versions in collaboration with Todai TLO (Technology Licensing Organization).
　
　

Key recent publications Matsunami et al., "Superstructure-based process synthesis and economic assessment under uncertainty for solid drug product manufacturing", BMC Chem Eng, 2, 6 (2020) Shirahata et al., "Online decision-support tool "TECHoice" for the equipment technology choice in sterile filling processes of biopharmaceuticals", Processes, 7(7), 448 (2019)

Press releases "Superstructure-based process synthesis and economic assessment under uncertainty for solid drug product manufacturing", The University of Tokyo, February 12, 2020 "Online decision-support tool “TECHoice” for the equipment technology choice", The University of Tokyo, July 18, 2019
Active members


Kensaku Matsunami	Yusuke Hayashi	Masahiro Yamada

　Systems med & pharma

In the modern healthcare society, the trend is growing toward drug diversification. With ever more treatment options being available for various diseases, e.g., infectious, lifestyle-related, and cancer, the entire system needs to be sustained. We have initiated an analytical study for advancing and diversifying drugs from a systems perspective, and to design and operate the whole. Our aim is to explore a multiscale systems engineering approach that can address challenges at all levels, encompassing development of cells and complex molecules and their application in healthcare, by treating various processes, such as research and development (R&D), manufacturing, and supply of drugs, as well as diagnosis and treatment of patients, in one framework. The main discussion forum will be in the Systems Med & Pharma Group, Division of Systems, Information, and Simulation Technologies (SIS) in the Society of Chemical Engineers (SCEJ), Japan, which was established in March 2020, and in the Pharma PSE COP of the International Society for Pharmaceutical Engineering (ISPE) Japan.

External links Systems Med & Pharma Group in the SIS Division of SCEJ
Pharma PSE COP in ISPE Japan
Active member


Hirokazu Sugiyama

Journal papers

35.	Yusuke Hayashi, Yuka Nakajima, Hirokazu Sugiyama "Computational screening of cryoprotective agents for regenerative medical products using quantum chemistry and molecular dynamics simulations" Cryobiology, accepted, DOI: 10.1016/j.cryobiol.2021.03.002
34.	Hirokazu Sugiyama, Norikazu Harada, Eri Amasawa, Masahiko Hirao, Naohisa Yahagi "A prototype method for selecting interventions for enhancing medication adherence in medicine taking processes" Journal of Chemical Engineering of Japan, accepted
33.	Keisho Yabuta, Haruka Futamura, Koji Kawasaki, Hirokazu Sugiyama "Integrated design of H₂O₂ decontamination processes and scheduling in sterile drug product manufacturing" Journal of Pharmaceutical Innovation, accepted, DOI: 10.1007/s12247-020-09434-4
32.	Masahiro Yamada, Sara Badr, Shouko Fukuda, Manabu Nakaya, Yasuyuki Yoshioka, Hirokazu Sugiyama "Economic Model for Lot-Size Determination in Pharmaceutical Injectable Manufacturing" Journal of Pharmaceutical Innovation, 16, 38–52 (2021), DOI: 10.1007/s12247-019-09410-7
31.	Anicia Zeberli, Sara Badr, Christian Siegmund, Markus Mattern, Hirokazu Sugiyama "Data-driven anomaly detection and diagnostics for changeover processes in biopharmaceutical drug product manufacturing" Chemical Engineering Research and Design, 167, 53–62 (2021), DOI: 10.1016/j.cherd.2020.12.018
30.	Yusuke Hayashi, Ikki Horiguchi, Masahiro Kino-oka, Hirokazu Sugiyama "Model-based assessment of temperature profiles in slow freezing for human induced pluripotent stem cells" Computers & Chemical Engineering, 144, 107150 (2021), DOI: 10.1016/j.compchemeng.2020.107150
29.	Hirokazu Sugiyama, Masaki Shiokaramatsu, Masashi Kagihiro, Kazuhiro Fukumori, Ikki Horiguchi, Masahiro Kino-oka "Apoptosis-based method for determining lot sizes in the filling of human induced pluripotent stem cells" Journal of Tissue Engineering and Regenerative Medicine, 14, 1641–1651 (2020), DOI: 10.1002/term.3127
28.	Keisho Yabuta, Haruka Futamura, Koji Kawasaki, Hirokazu Sugiyama "Impact of H₂O₂ sorption by polymers on the duration of aeration in pharmaceutical decontamination" Journal of Pharmaceutical Sciences, 109, 2767–2773 (2020), DOI: 10.1016/j.xphs.2020.05.024
27.	Philipp Samuel Zürcher, Haruku Shirahata, Sara Badr, Hirokazu Sugiyama "Multi-stage and multi-objective decision-support tool for biopharmaceutical drug product manufacturing: equipment technology evaluation" Chemical Engineering Research and Design, 161, 240–252 (2020), DOI: 10.1016/j.cherd.2020.07.004
26.	Sara Badr, Hirokazu Sugiyama "A PSE perspective for the efficient production of monoclonal antibodies: Integration of process, cell, and product design aspects" Current Opinion in Chemical Engineering, 27, 121–128 (2020), DOI: 10.1016/j.coche.2020.01.003
25.	Anicia Zeberli, Gioele Casola, Sara Badr, Christian Siegmund, Markus Mattern, Hirokazu Sugiyama "Approach for multicriteria equipment redesign in sterile manufacturing of biopharmaceuticals" Journal of Pharmaceutical Innovation, 15, 15–25 (2020), DOI: 10.1007/s12247-018-9355-8
24.	Kensaku Matsunami, Takuya Nagato, Koji Hasegawa, Hirokazu Sugiyama "Determinig key parameters of continuous wet granulation for tablet quality and productivity: A case in ethenzamide" International Journal of Pharmaceutics, 579, 119160 (2020), DOI: 10.1016/j.ijpharm.2020.119160
23.	Kensaku Matsunami, Fabian Sternal, Keita Yaginuma, Shuichi Tanabe, Hiroshi Nakagawa, Hirokazu Sugiyama "Superstructure-based process synthesis and economic assessment under uncertainty for solid drug product manufacturing" BMC Chemical Engineering, 2, 6 (2020), DOI: 10.1186/s42480-020-0028-2
22.	Yusuke Hayashi, Ikki Horiguchi, Masahiro Kino-oka, Hirokazu Sugiyama "Slow Freezing Process Design for Human Induced Pluripotent Stem Cells by Modeling Intracontainer Variation" Computers & Chemical Engineering, 132, 106597 (2020) DOI: 10.1016/j.compchemeng.2019.106597
21.	Hirokazu Sugiyama, Masaki Shiokaramatsu, Masahiro Kino-oka "A distribution-based approach for determining lot sizes in the filling of human-induced pluripotent stem cells" Regenerative Therapy, 12, 94–101 (2019), DOI: 10.1016/j.reth.2019.04.012
20.	Haruku Shirahata, Samir Diab, Hirokazu Sugiyama, Dimitrios I. Gerogiorgis "Dynamic modelling, simulation and economic evaluation of two CHO cell-based production modes towards developing biopharmaceutical manufacturing processes" Chemical Engineering Research and Design, 150, 218–233 (2019), DOI: 10.1016/j.cherd.2019.07.016
19.	Haruku Shirahata, Sara Badr, Yuki Shinno, Shuta Hagimori, Hirokazu Sugiyama "Online decision-support tool "TECHoice" for the equipment technology choice in sterile filling processes of biopharmaceuticals" Processes, 7(7), 448 (2019), DOI: 10.3390/pr7070448
18.	Gioele Casola, Christian Siegmund, Markus Mattern, Hirokazu Sugiyama "Data mining algorithm for pre-processing biopharmaceutical drug product manufacturing records" Computers & Chemical Engineering, 124, 253–269 (2019), DOI: 10.1016/j.compchemeng.2018.12.001
17.	Haruku Shirahata, Sara Badr, Shant Dakessian, Hirokazu Sugiyama "Alternative generation and multiobjective evaluation using a design framework: case study on sterile filling processes of biopharmaceuticals" Computers & Chemical Engineering, 123, 286–299 (2019), DOI: 10.1016/j.compchemeng.2018.12.019
16.	Kensaku Matsunami, Takuya Nagato, Koji Hasegawa, Hirokazu Sugiyama "A large-scale experimental comparison of batch and continuous technologies in pharmaceutical tablet manufacturing using ethenzamide" International Journal of Pharmaceutics, 559, 210–219 (2019), DOI: 10.1016/j.ijpharm.2019.01.028
15.	Haruku Shirahata, Masahiko Hirao, Hirokazu Sugiyama "Multiobjective decision-support tools for the choice between single-use and multi-use technologies in sterile filling of biopharmaceuticals" Computers & Chemical Engineering, accepted, 122, 114–128 (2019) DOI: 10.1016/j.compchemeng.2018.06.001
14.	Hirokazu Sugiyama, Yusuke Morikawa, Mai Matsuura, Menghe Xu "Relevance of regulatory constraints in designing pharmaceutical manufacturing processes: A case study on waste solvent recovery" Sustainable Production and Consumption, 17, 136–147 (2019), DOI: 10.1016/j.spc.2018.09.003
13.	Kensaku Matsunami, Takuya Miyano, Hiroaki Arai, Hiroshi Nakagawa, Masahiko Hirao, Hirokazu Sugiyama "Decision support method for the choice between batch and continuous technologies in solid drug product manufacturing" Industrial & Engineering Chemistry Research, 57(30), 9798–9809 (2018), DOI: 10.1021/acs.iecr.7b05230
12.	Keisho Yabuta, Haruka Futamura, Koji Kawasaki, Masahiko Hirao, Hirokazu Sugiyama "Design-oriented regression models for H₂O₂ decontamination processes in sterile drug product manufacturing considering rapidity and sterility" International Journal of Pharmaceutics, 548, 466–473 (2018), DOI: 10.1016/j.ijpharm.2018.06.055
11.	Gioele Casola, Christian Siegmund, Markus Mattern, Hirokazu Sugiyama "Uncertainty-conscious methodology for process performance assessment in biopharmaceutical drug product manufacturing" AIChE Journal, 64(4), 1272–1284 (2018), DOI: 10.1002/aic.16020
10.	Keisho Yabuta, Masahiko Hirao, Hirokazu Sugiyama "Process model for enhancing yield in sterile drug product manufacturing" Journal of Pharmaceutical Innovation, 12(3), 194–205 (2017) DOI: 10.1007/s12247-017-9278-9
9.	Lukas Gallus Eberle, Alexander Svensson, Andreas Graser, Jörg Lümkemann, Hirokazu Sugiyama, Rainer Schmidt, Konrad Hungerbühler "Innovative approach for identifying root causes of glass defects in sterile drug product manufacturing" European Journal of Pharmaceutical Sciences, 104, 162–170 (2017), DOI: 10.1016/j.ejps.2017.03.015
8.	Haruku Shirahata, Masahiko Hirao, Hirokazu Sugiyama "Decision-support method for the choice between single-use and multi-use technologies in sterile drug product manufacturing" Journal of Pharmaceutical Innovation, 12(1), 1–13 (2017), DOI: 10.1007/s12247-016-9264-7
7.	Akiko Segawa, Satoshi Yoshikawa, Takayuki Toyama, Hayao Nakanishi, Emi Kikuchi-Uehara, Masahiko Hirao, Hirokazu Sugiyama "Method for reducing environmental, health, and safety risks in active pharmaceutical ingredient manufacturing based on multiobjective evaluation" Process Safety and Environmental Protection, 104, 304-313 (2016), DOI: 10.1016/j.psep.2016.09.005
6.	Lukas Gallus Eberle, Elisabet Capón-Carcía, Andreas Graser, Rainer Schmidt, Konrad Hungerbühler "Rigorous Approach to Scheduling of Sterile Drug Product Manufacturing" Computers & Chemical Engineering, 94, 221–234 (2016), DOI: 10.1016/j.compchemeng.2016.07.028
5.	Lukas Gallus Eberle, Hirokazu Sugiyama, Stavros Papadokonstantakis, Andreas Graser, Rainer Schmidt, Konrad Hungerbühler "Data-driven Tiered Procedure for Enhancing Yield in Drug Product Manufacturing" Computers & Chemical Engineering, 87, 82–94 (2016), DOI: 10.1016/j.compchemeng.2015.12.012
4.	Takuya Miyano, Hiroshi Nakagawa, Tomoyuki Watanabe, Hidemi Minami, Hirokazu Sugiyama "Operationalizing maintenance of calibration models based on near-infrared spectroscopy by knowledge integration" Journal of Pharmaceutical Innovation, 10, 287–301 (2015), DOI: 10.1007/s12247-015-9226-5
3.	Takayuki Iida, Kosuke Ota, Tomohito Sasozaki, Hirokazu Sugiyama "Multiobjective design method for the use processes of pharmaceutical excipients considering quality and cost-effectiveness"Journal of Pharmaceutical Innovation, 10, 313–323 (2015), DOI: 10.1007/s12247-015-9228-3
2.	Gioele Casola, Satoshi Yoshikawa, Hayao Nakanishi, Masahiko Hirao, Hirokazu Sugiyama "Systematic retrofitting methodology for pharmaceutical drug purification processes" Computers & Chemical Engineering, 80, 177–188 (2015), DOI: 10.1016/j.compchemeng.2015.05.024
1.	Hirokazu Sugiyama, Masaaki Ito, Masahiko Hirao "Planning method for reducing product losses in manufacturing sterile drug products" Journal of Chemical Engineering of Japan, 48, 848–855 (2015), DOI: 10.1252/jcej.14we422

Theses

42.	Yuki Yoshiyama	"(Title in Japanese)" Bachelor thesis in FY 2020, The University of Tokyo
41.	Shungo Matsueda	"(Title in Japanese)" Bachelor thesis in FY 2020, The University of Tokyo
40.	Akinori Shigeyama	"(Title in Japanese)" Bachelor thesis in FY 2020, The University of Tokyo
39.	Harjowinoto Danny	"Quality and productivity assessment of small-scale tablet manufacturing " Master thesis in FY 2020, The University of Tokyo
38.	Nozomi Takahashi	"Robust design of capture chromatography processes in monoclonal antibody production" Master thesis in FY 2020, The University of Tokyo
37.	Kozue Okamura	"Modeling and design of cell cultivation processes in monoclonal antibody production" Master thesis in FY 2020, The University of Tokyo
36.	Kensaku Matsunami	"Integrated design framework for solid drug product manufacturing processes considering continuous technology" PhD thesis in FY 2020, The University of Tokyo
35.	Zeberli Anicia	"Computer-aided approach for design and operation support of changeover processes in biopharmaceutical drug product manufacturing" PhD thesis in FY 2020, The University of Tokyo
34.	Tatsuki Yoshida	"(Title in Japanese)" Bachelor thesis in FY 2019, The University of Tokyo
33.	Hiroaki Kuroda	"(Title in Japanese)" Bachelor thesis in FY 2019, The University of Tokyo
32.	Masahiro Yamada	"Design method for injectable manufacturing processes considering continuous and batch modes" Master thesis in FY 2019, The University of Tokyo
31.	Tomohiro Miura	"(Title in Japanese)" Master thesis in FY 2019, The University of Tokyo
30.	Kosuke Kusumoto	"(Title in Japanese)" Master thesis in FY 2019, The University of Tokyo
29.	Junu Kim	"Decision support method for the choice between batch and flow syntheses in drug substance manufacturing" Master thesis in FY 2019, The University of Tokyo
28.	Keisho Yabuta	"Model-based design of hydrogen peroxide decontamination processes in sterile drug product manufacturing" PhD thesis in FY 2019, The University of Tokyo
27.	Haruku Shirahata	"Holistic design of biopharmaceutical production processes considering single-use technology and continuous manufacturing" PhD thesis in FY 2019, The University of Tokyo
26.	Nozomi Takahashi	(Title in Japanese) Bachelor thesis in FY 2018, The University of Tokyo
25.	Kozue Okamura	"Dynamic simulation and process assessment of cell cultivation modes in monoclonal antibody production" Bachelor thesis in FY 2018, The University of Tokyo
24.	Yusuke Hayashi	"Design of freezing processes for human induced pluripotent stem cells towards industrial manufacturing" Master thesis in FY 2018, The University of Tokyo
23.	Koichi Hayashi	(Title in Japanese) Master thesis in FY 2018, The University of Tokyo
22.	Masaki Shiokaramatsu	(Title in Japanese) Master thesis in FY 2018, The University of Tokyo
21.	Philipp Zuercher	"Multi-stage and Multi-objective Decision Support Tool for Process Design of Biopharmaceutical Drug Product Manufacturing" Master thesis in 2018, ETH Zurich
20.	Gioele Casola	"Framework for data-driven process improvement and operations support in biopharmaceutical drug product manufacturing" PhD thesis in FY 2018, The University of Tokyo
19.	Masahiro Yamada	"Lot-sizing method in parenterals manufacturing processes based on economic evaluation" (Original title in Japanese) Bachelor thesis in FY 2017, The University of Tokyo
18.	Kosuke Kusumoto	(Title in Japanese) Bachelor thesis in FY 2017, The University of Tokyo
17.	Kensaku Matsunami	"Design method of solid drug product manufacturing processes in clinical development" Master thesis in FY 2017, The University of Tokyo
16.	Shohei Fukuhara	"Method for reducing EHS risks in drug substance manufacturing considering process characteristics" (Original title in Japanese) Master thesis in FY 2017, The University of Tokyo
15.	Norikazu Harada	"Methodology for selecting reduction measures of unused medicine considering patient characteristics" (Original title in Japanese) Master thesis in FY 2017, The University of Tokyo
14.	Dakessian Shant	"Systematic generation and evaluation of equipment technology options in parenterals manufacturing" Master thesis in 2017, ETH Zurich
13.	Zeberli Anicia	"Application of computational fluid dynamics for equipment redesign in sterile manufacturing of biopharmaceuticals" Master thesis in 2017, ETH Zurich
12.	Masaki Shiokaramatsu	"Design of working cell bank of allogeneic iPS cells using Monte Carlo simulation" (Original title in Japanese) Bachelor thesis in FY 2016, The University of Tokyo
11.	Keisho Yabuta	"Design methodology of decontamination processes using hydrogen peroxide in pharmaceutical manufacturing" Master thesis in FY 2016, The University of Tokyo
10.	Haruku Shirahata	"Design methodology of parenterals manufacturing processes considering the choice between single-use and multi-use technologies" Master thesis in FY 2016, The University of Tokyo
9.	Masaaki Ito	"Method for material loss reduction in drug product manufacturing processes" (Original title in Japanese) Master thesis in FY 2016, The University of Tokyo
8.	Kensaku Matsunami	"Design method for pharmaceutical tablet manufacturing processes considering the choice between batch and continuous technologies" (Original Title in Japanese) Bachelor thesis in FY 2015, The University of Tokyo
7.	Akira Hashimoto	"Method for supporting countermeasures for reducing unused medicines" (Original Title in Japanese) Bachelor thesis in FY 2015, The University of Tokyo
6.	Yuuki Uchida	"Method for reducing EHS risks of solvent usage of pharmaceutical drug substance manufacuring" (Original Title in Japanese) Bachelor thesis in FY 2015, The University of Tokyo
5.	Keisho Yabuta	"Construction of mathematical model for pharmaceutical batch processes" (Original Title in Japanese) Bachelor thesis in FY 2014, The University of Tokyo
4.	Akiko Segawa	"Method for reducing environmental, health and safety (EHS) risks in pharmaceutical drug substance manufacturing based on multiobjective evaluation" (Original Title in Japanese) Bachelor thesis in FY 2014, The University of Tokyo
3.	Haruku Shirahata	"Supporting method for the choice between single- and multi-use technologies in manufacturing sterile drug products" (Original Title in Japanese) Bachelor thesis in FY 2014, The University of Tokyo
2.	Gioele Casola	"Systematic retrofitting methodology for pharmaceutical drug purification Processes" Master thesis in 2014, ETH Zurich
1.	Masaaki Ito	"Supporting method for reducing product losses in manufacutring sterile drug products" (Original Title in Japanese) Bachelor thesis in FY 2013, The University of Tokyo

Commentaries and book chapters

33.	林勇佑, 杉山弘和 "Pharma PSE Spotlight 第13回：ヒトiPS細胞の緩慢凍結プロセスにおける冷却温度プロファイルのモデルベースト評価" Pharm Tech Japan, 37, 255–259 (2021)
32.	杉山弘和, 松並研作 "固形剤製造プロセスの経済性評価シミュレーションとツール実装" 化学装置, 2021年1月号, 57–62 (2021)
31.	松並研作, 杉山弘和 "固形剤の連続製造プロセス設計と経済性評価" フロー合成、連続生産のプロセス設計、条件設定と応用事例, 技術情報協会, ISBN 978-4-86104-820-3, 第8章第9節 (2020)
30.	藪田啓奨, 杉山弘和 "Pharma PSE Spotlight 第12回：無菌製剤製造における除染プロセスとスケジューリングの統合設計" Pharm Tech Japan, 36, 2421–2426 (2020)
29.	松並研作, 杉山弘和 "固形製剤の製法設計のためのシミュレーションツール" Pharm Tech Japan, 36, 1257–1262 (2020)
28.	山田真弘, 杉山弘和 "Pharma PSE Spotlight 第11回：経済性評価に基づく注射剤製造プロセスのロットサイズ決定" Pharm Tech Japan, 36, 871–875 (2020)
27.	岡村梢, 松並研作, 白畑春来, 杉山弘和 "2019 AIChE Annual Meeting参加報告・紹介" Pharm Tech Japan, 36, 149–150 (2020)
26.	Hirokazu Sugiyama "Pharma PSE Research at The University of Tokyo" PD2M Newsletter, 2 (2019)
25.	林勇佑, 杉山弘和 "Pharma PSE Spotlight 第10回：容器内ばらつきのモデル化によるヒトiPS細胞の緩慢凍結プロセス設計" Pharm Tech Japan, 35, 2965–2968 (2019)
24.	白畑春来, 杉山弘和 "Pharma PSE Spotlight 第9回：バイオ医薬品無菌充填工程を対象とするオンライン技術選択支援ツール"TECHoice"" Pharm Tech Japan, 35, 2605–2610 (2019)
23.	杉山弘和, 松並研作 "連続生産を対象とするプロセスシステム工学研究" 固形製剤とバイオ原薬の連続生産, 竹内洋文(監修), シーエムシー出版, ISBN 978-4-7813-1425-9, pp. 130–139 (2019)
22.	松並研作, 杉山弘和 "Pharma PSE Spotlight 第8回：エテンザミドを用いた医薬品錠剤製造におけるバッチ・連続技術の大スケール実験的検討" Pharm Tech Japan, 35, 1533–1537 (2019)
21.	白畑春来, 杉山弘和 "Pharma PSE Spotlight 第7回：バイオ医薬品無菌充填におけるシングルユース・マルチユース技術の多目的選択支援ツール" Pharm Tech Japan, 35, 377–383 (2019)
20.	藪田啓奨, 杉山弘和 "Pharma PSE Spotlight 第6回：過酸化水素除染プロセスの多目的設計に向けた統計モデル" Pharm Tech Japan, 34, 2941–2946 (2018)
19.	杉山弘和, 松並研作 "製剤と粒子設計：意思決定の切り口からみた製剤の連続生産" Pharm Tech Japan, 34, 2261–2265 (2018)
18.	藪田啓奨, 杉山弘和 "Pharma PSE Spotlight 第5回：無菌製剤製造における収率向上のためのプロセスモデル" Pharm Tech Japan, 34, 1329–1334 (2018)
17.	Gioele Casola "創薬・創剤人　リアルデータを基にしたアルゴリズムで工程改善　Gioele Casola氏" Pharm Tech Japan, 34, 822–823 (2018)
16.	杉山弘和 "Pharma PSE Spotlight 第4回：注射剤製造における賦形剤使用プロセスの多目的設計手法" Pharm Tech Japan, 34, 300–304 (2018)
15.	藪田啓奨, 杉山弘和, 川﨑康司 "過酸化水素除染プロセスを対象とする工学研究のアプローチ" 新東技報, 35, 32–37 (2017)
14.	杉山弘和 "Pharma PSE Spotlight 第3回： ISPE日本本部 Pharma PSE COPの紹介" Pharm Tech Japan, 33, 2911–2916 (2017)
13.	松並研作, 杉山弘和 "連続生産を対象とするプロセスシステム工学研究" Pharm Tech Japan, 33, 2619–2625 (2017)
12.	白畑春来, 杉山弘和 "Pharma PSE Spotlight 第2回：注射剤製造におけるシングルユース・マルチユース技術の選択支援手法" Pharm Tech Japan, 33, 1529–1535 (2017)
11.	杉山弘和, 伊藤正晃 "Pharma PSE Spotlight 第1回：無菌製剤製造における製品ロス低減のための計画手法" Pharm Tech Japan, 33, 975–979 (2017)
10.	杉山弘和 "製薬プロセスシステム工学Pharma PSEの開拓" Pharm Tech Japan, 32, 2421–2426 (2016)
9.	杉山弘和 "注射剤製造プロセスの設計と改善の方法論" 注射剤製造における無菌性保証・バリデーションと異物低減ノウハウ・検査事例, サイエンスアンドテクノロジー, ISBN 978-4-86428-146-1, pp. 337–359 (2016)
8.	杉山弘和 "医薬品製造を対象とするプロセスシステム工学の最新動向" 化学工学, 80, 450 (2016)
7.	杉山弘和 "医薬品製造を対象とするモデル化・シミュレーション・最適化研究" クリーンテクノロジー, 26, 65–68 (2016)
6.	杉山弘和 "医薬品製造プロセスの多目的設計" 化学工業, 66, 952–958 (2015)
5.	杉山弘和 "医薬品製造を対象とする新しいプロセスシステム工学「Pharma PSE」" 化学工学会バイオ部会ニュースレター, 40, 3–6 (2015)
4.	杉山弘和 "医薬品生産における統合化工学とは" 抗体医薬品における細胞構築・培養・ダウンストリームのすべて, 大政健史（編）, シーエムシー出版, ISBN 978-4-7813-1046-0, pp. 265–273 (2015)
3.	杉山弘和 "優れた医薬品製造プロセスの実現にむけた工学研究のアプローチ" 薬剤学, 74, 305–311 (2014)
2.	杉山弘和 "スイスの製薬会社ロシュに勤務して" 化学工学, 78, 347–348 (2014)
1.	杉山弘和 "スイス・ロシュ注射剤製造の現場から" 薬剤学, 73, 86–89 (2013)

International conferences

76.	Kensaku Matsunami, Tomohiro Miura, Keita Yaginuma, Shuichi Tanabe, Hirokazu Sugiyama "Surrogate Modeling of Dissolution Behavior Toward Efficient Design of Tablet Manufacturing Processes" Oral, 2020 AIChE Annual Meeting, 16–20 November 2020, Virtual meeting
75.	Keisho Yabuta, Haruka Futamura, Koji Kawasaki, Hirokazu Sugiyama "H₂O₂ Decontamination for Sterile Manufactruing: Impact of Sorption By Polymers on the Duration of Aeration" Oral, 2020 AIChE Annual Meeting, 16–20 November 2020, Virtual meeting
74.	Masahiro Yamada, Yasuyuki Yoshioka, Hayao Nakanishi, Hirokazu Sugiyama "Design Method for Injectable Manufacturing Processes Considering Continuous and Batch Compounding" Oral, 2020 AIChE Annual Meeting, 16–20 November 2020, Virtual meeting
73.	Sara Badr, Kozue Okamura, Nozomi Takahashi, Hirokazu Sugiyama "Design of Integrated Monoclonal Antibody Production Processes: Modelling, Data, and Process Challenges" Oral, 2020 AIChE Annual Meeting, 16–20 November 2020, Virtual meeting
72.	Yusuke Hayashi, Ikki Horiguchi, Masahiro Kino-Oka, Hirokazu Sugiyama "Model-Based Assessment of Freezing Temperature Profiles for Human Induced Pluripotent Stem Cells" Poster, 2020 AIChE Annual Meeting, 16–20 November 2020, Virtual meeting
71.	Philipp Zürcher, Sara Badr, Hirokazu Sugiyama "Data-Driven Approaches Towards Real-Time Equipment Health Monitoring and Predictive Maintenance in Drug Product Manufacturing" Oral, 2020 AIChE Annual Meeting, 16–20 November 2020, Virtual meeting
70.	Kozue Okamura, Sara Badr, Hirokazu Sugiyama "Simulation of cultivation processes in monoclonal antibody production towards the selection of operation modes" Oral, The 9th Asian Symposium on Process Systems Engineering (9th PSE Asia), 4–6 November 2020, Virtual meeting
69.	Keisho Yabuta, Haruka Futamura, Koji Kawasaki, Hirokazu Sugiyama "Model-based design of H₂O₂ decontamination processes in pharmaceutical manufacturing" Oral, The 9th Asian Symposium on Process Systems Engineering (9th PSE Asia), 4–6 November 2020, Virtual meeting
68.	Junu Kim, Hironori Yonekura, Takeaki Watanabe, Satoshi Yoshikawa, Hayao Nakanishi, Hirokazu Sugiyama "Batch and flow syntheses of drug substances: a model-based comparison in heterogeneous hydrogenation" Oral, The 9th Asian Symposium on Process Systems Engineering (9th PSE Asia), 4–6 November 2020, Virtual meeting
67.	Yusuke Hayashi, Yuka Nakajima, Hirokazu Sugiyama "Quantum chemistry and molecular dynamics simulations on cryoprotective agents for human stem cells" Oral, The 9th Asian Symposium on Process Systems Engineering (9th PSE Asia), 4–6 November 2020, Virtual meeting
66.	Samir Diab, Sara Badr, Hirokazu Sugiyama, Dimitrios Gerogiorgis "Dynamic simulation and visualisation of pH-modulated fed-batch fermentation for mAb production from CHO cell cultures" Poster, The 30th European Symposium on Computer-Aided Process Engineering (ESCAPE-30), 30 August–2 September 2020, Virtual meeting
65.	Keisho Yabuta, Haruka Futamura, Koji Kawasaki, Hirokazu Sugiyama "Integrated design of process configuration and scheduling for hydrogen peroxide decontamination in biopharmaceutical injectable manufacturing" Poster, The 30th European Symposium on Computer-Aided Process Engineering (ESCAPE-30), 30 August–2 September 2020, Virtual meeting
64.	Yusuke Hayashi, Ikki Horiguchi, Masahiro Kino-Oka, Hirokazu Sugiyama "Multiobjective dynamic optimization of slow freezing processes for human induced pluripotent stem cells by modeling intracontainer condition" Oral, The 30th European Symposium on Computer-Aided Process Engineering (ESCAPE-30), 30 August–2 September 2020, Virtual meeting
63.	Sara Badr, Kozue Okamura, Nozomi Takahashi, Vera Ubbenjans, Haruku Shirahata, Hirokazu Sugiyama "Integrated design of biopharmaceutical manufacturing processes: operation modes and process configurations for monoclonal antibody production" Oral, The 30th European Symposium on Computer-Aided Process Engineering (ESCAPE-30), 30 August–2 September 2020, Virtual meeting
62.	Yusuke Hayashi, Ikki Horiguchi, Masahiro Kino-oka, Hirokazu Sugiyama "Model-based design of freezing temperature profile for human induced pluripotent stem cells" Oral, The 57th Annual Meeting of the Society for Cryobiology (CRYO2020), 21–23 July 2020, Virtual meeting
61.	Hirokazu Sugiyama [Keynote lecture] "Process Systems Engineering for Pharmaceutical Process Design and Operation" Oral, 2019 3rd International Conference on Functional Materials and Chemical Engineering (ICFMCE-2019), 15–17 December 2019, Chulalongkorn University, Bangkok, Thailand
60.	Sara Badr, Kozue Okamura, Nozomi Takahashi, Haruku Shirahata, Hirokazu Sugiyama "Design of integrated monoclonal antibody production: opportunities for continuous manufacturing" Oral, 2019 AIChE Annual Meeting, 10–15 November 2019, Hyatt Regency, Orlando, U.S.A.
59.	Anicia Zeberli, Sara Badr, Christian Siegmund, Markus Mattern, Hirokazu Sugiyama "Data-driven predictive monitoring and operation support for change-over processes in biopharmaceutical drug product manufacturing" Oral, 2019 AIChE Annual Meeting, 10–15 November 2019, Hyatt Regency, Orlando, U.S.A.
58.	Kozue Okamura, Sara Badr, Hirokazu Sugiyama "Dynamic simulation and process assessment of cultivation modes in monoclonal antibody production using pilot-scale experimental data" Oral, 2019 AIChE Annual Meeting, 10–15 November 2019, Hyatt Regency, Orlando, U.S.A.
57.	Kensaku Matsunami, Fabian Sternal, Keita Yaginuma, Shuichi Tanabe, Hiroshi Nakagawa, Hirokazu Sugiyama "Economic evaluation tool for holistic design of solid drug product manufacturing processes considering continuous technology" Oral, 2019 AIChE Annual Meeting, 10–15 November 2019, Hyatt Regency, Orlando, U.S.A.
56.	Yusuke Hayashi, Ikki Horiguchi, Masahiro Kino-oka, Hirokazu Sugiyama "Slow freezing process design for human induced pluripotent stem cells by modeling intracontainer variation" Oral, 2019 AIChE Annual Meeting, 10–15 November 2019, Hyatt Regency, Orlando, U.S.A.
55.	Haruku Shirahata, Sara Badr, Hirokazu Sugiyama "Alternative generation and evaluation using a design framework: Case study on drug substance manufacturing processes of biopharmaceuticals" Poster, 2019 AIChE Annual Meeting, 10–15 November 2019, Hyatt Regency, Orlando, U.S.A.
54.	Yusuke Hayashi, Ikki Horiguchi, Masahiro Kino-oka, Hirokazu Sugiyama "Simulation-based design of slow freezing processes for human induced pluripotent stem cells considering intracontainer variation" Oral, 18th Asian Pacific Confederation of Chemical Engineering Congress (APCChE 2019), 23–27 September 2019, Sapporo Convention Center, Sapporo, Japan
53.	Hirokazu Sugiyama, Kozue Okamura, Nozomi Takahashi, Haruku Shirahata, Sara Badr "Simulation-based design of monoclonal antibody production processes considering integrated continuous manufacturing" Oral, 18th Asian Pacific Confederation of Chemical Engineering Congress (APCChE 2019), 23–27 September 2019, Sapporo Convention Center, Sapporo, Japan
52.	Keisho Yabuta, Haruka Futamura, Koji Kawasaki, Hirokazu Sugiyama "Simultaneous design of process and scheduling for pharmaceutical decontamination" Oral, 18th Asian Pacific Confederation of Chemical Engineering Congress (APCChE 2019), 23–27 September 2019, Sapporo Convention Center, Sapporo, Japan
51.	Sara Badr, Kozue Okamura, Nozomi Takahashi, Haruku Shirahata, Hirokazu Sugiyama "Process design of integrated monoclonal antibody manufacturing using pilot-scale production data" Oral, 18th Asian Pacific Confederation of Chemical Engineering Congress (APCChE 2019), 23–27 September 2019, Sapporo Convention Center, Sapporo, Japan
50.	Anicia Zeberli, Sara Badr, Christian Siegmund, Markus Mattern, Hirokazu Sugiyama "Machine learning applications for predictive operation support in change-over processes of biopharmaceutical drug product manufacturing" Oral, 18th Asian Pacific Confederation of Chemical Engineering Congress (APCChE 2019), 23–27 September 2019, Sapporo Convention Center, Sapporo, Japan
49.	Yusuke Hayashi, Ikki Horiguchi, Masahiro Kino-oka, Masahiko Hirao, Hirokazu Sugiyama "Freeze-thaw process design of induced pluripotent stem cells using white-box models" Poster, 29th European Symposium on Computer Aided Process Engineering (ESCAPE-29), 16–19 June 2019, Evoluon, Eindhoven, Netherland.
48.	Haruku Shirahata, Samir Diab, Hirokazu Sugiyama, Dimitrios Gerogiorgis "Dynamic modelling and simulation of chinese hamster ovary (CHO) cell fermentation for advanced biopharmaceutical manufacturing" Oral, 29th European Symposium on Computer Aided Process Engineering (ESCAPE-29), 16–19 June 2019, Evoluon, Eindhoven, Netherland.
47.	Hirokazu Sugiyama [Keynote lecture]"Roles of process systems engineering in the design and operation of pharmaceutical manufacturing processes" Oral, The 8th International Symposium on Design, Operation, and Control of Chemical Processes (PSE Asia 2019), 13–16 January 2019, Chulalongkorn University, Bangkok, Thailand
46.	Yusuke Hayashi, Masahiro Kino-oka, Ikki Horiguchi, Masahiko Hirao, Hirokazu Sugiyama "Computer-aided design of freeze-thaw processes of induced pluripotent stem cells" Oral, The 8th International Symposium on Design, Operation, and Control of Chemical Processes (PSE Asia 2019), 13–16 January 2019, Chulalongkorn University, Bangkok, Thailand
45.	Masahiro Yamada, Sara Badr, Shouko Fukuda, Manabu Nakaya, Yasuyuki Yoshioka, Masahiko Hirao, Hirokazu Sugiyama "Model-based determination of lot-size in pharmaceutical injectable manufacturing" Oral, The 8th International Symposium on Design, Operation, and Control of Chemical Processes (PSE Asia 2019), 13–16 January 2019, Chulalongkorn University, Bangkok, Thailand
44.	Kensaku Matsunami, Hirokazu Sugiyama "Holistic and model-based design of oral drug manufacturing processes considering uncertainty in clinical development" Oral, The 8th International Symposium on Design, Operation, and Control of Chemical Processes (PSE Asia 2019), 13–16 January 2019, Chulalongkorn University, Bangkok, Thailand
43.	Samir Diab, Haruku Shirahata, Hirokazu Sugiyama, Dimitrios I. Gerogiorgis "Process modelling, simulation and optimisation for continuous biopharmaceutical manufacturing" Oral, 2018 AIChE Annual Meeting, 28 October – 2 November 2018, David L. Lawrence Convention Center, Pittsburgh, U.S.A.
42.	Haruku Shirahata, Philipp Zürcher, Sara Badr, Hirokazu Sugiyama "Multi-stage and multi-objective design tool for process design in sterile filling of biopharmaceuticals" Poster, 2018 AIChE Annual Meeting, 28 October – 2 November 2018, David L. Lawrence Convention Center, Pittsburgh, U.S.A.
41.	Anicia Zeberli, Sara Badr, Christian Siegmund, Markus Mattern, Hirokazu Sugiyama "Data-driven real-time operation support for decontamination processes in biopharmaceutical drug product manufacturing" Oral, 2018 AIChE Annual Meeting, 28 October – 2 November 2018, David L. Lawrence Convention Center, Pittsburgh, U.S.A.
40.	Masaki Shiokaramatsu, Masahiro Kino-oka, Ikki Horiguchi, Masahiko Hirao, Hirokazu Sugiyama "Models for designing suspension and filling process of human induced pluripotent stem cells considering survival rate" Poster, 5th Tissue Engineering and Regenerative Medicine International Society World Congress (5th TERMIS World Congress), 4–7 September 2018, Kyoto International Conference Center, Kyoto, Japan
39.	Yusuke Hayashi, Masahiro Kino-oka, Ikki Horiguchi, Masahiko Hirao, Hirokazu Sugiyama "Models for designing freeze-thaw process of human induced pluripotent stem cells towards commercial manufacturing" Poster, 5th Tissue Engineering and Regenerative Medicine International Society World Congress (5th TERMIS World Congress), 4–7 September 2018, Kyoto International Conference Center, Kyoto, Japan
38.	Haruku Shirahata, Shant Dakessian, Masahiko Hirao, Hirokazu Sugiyama "Multilayer and multiobjective design platform for drug product manufacturing processes of biopharmaceuticals" Oral, 13th International Symposium on Process Systems Engineering (PSE 2018), 1–5 July 2018, Manchester Grand Hyatt, San Diego, U.S.A.
37.	Kensaku Matsunami, Shuichi Tanabe, Hiroshi Nakagawa, Masahiko Hirao, Hirokazu Sugiyama "Economic evaluation of batch and continuous manufacturing technologies for solid drug products during clinical development" Oral, 13th International Symposium on Process Systems Engineering (PSE 2018), 1–5 July 2018, Manchester Grand Hyatt, San Diego, U.S.A.
36.	Hirokazu Sugiyama, Yusuke Morikawa, Mai Matsuura, Menghe Xu "Quantitative analysis on the relevance of regulatory constraints in designing pharmaceutical manufacturing processes" Oral, 13th International Symposium on Process Systems Engineering (PSE 2018), 1–5 July 2018, Manchester Grand Hyatt, San Diego, U.S.A.
35.	Gioele Casola, Christian Siegmund, Markus Mattern, Hirokazu Sugiyama "Data mining-based algorithm for pre-processing biopharmaceutical manufacturing records" Oral, 13th International Symposium on Process Systems Engineering (PSE 2018), 1–5 July 2018, Manchester Grand Hyatt, San Diego, U.S.A.
34.	Keisho Yabuta, Haruka Futamura, Koji Kawasaki, Masahiko Hirao, Hirokazu Sugiyama "Models for designing hydrogen peroxide decontamination processes in sterile drug product manufacturing" Oral, 28th European Symposium on Computer Aided Process Engineering (ESCAPE-28), 10–13 June 2018, the Congress Graz, Graz, Austria.
33.	Kensaku Matsunami, Takuya Nagato, Koji Hasegawa, Masahiko Hirao, Hirokazu Sugiyama "Industrial scale experiments towards the development of process evaluation models for continuous pharmaceutical tablet manufacturing" Poster, 28th European Symposium on Computer Aided Process Engineering (ESCAPE-28), 10–13 June 2018, the Congress Graz, Graz, Austria.
32.	Kensaku Matsunami*, Takuya Nagato, Koji Hasegawa, Masahiko Hirao, Hirokazu Sugiyama "Large-scale experimental comparison of batch and continuous technologies for pharmaceutical tablet manufacturing" Oral, 2017 AIChE Annual Meeting, 29 October-3 Nobember 2017, Minneapolis Convention Center, Minneapolis, U.S.A.
31.	Haruku Shirahata*, Masahiko Hirao, Hirokazu Sugiyama "Risk evaluation models for the design of parenterals manufacturing processes" Oral, 27th European Symposium on Computer Aided Process Engineering (ESCAPE-27), 1-5 October 2017, Fira de Barcelona, Barcelona, Spain.
30.	Hirokazu Sugiyama*, Kensaku Matsunami, Keisho Yabuta "Process systems engineering approaches for drug product manufacturing: from tablets to injectables" Poster, 27th European Symposium on Computer Aided Process Engineering (ESCAPE-27), 1-5 October 2017, Fira de Barcelona, Barcelona, Spain.
29.	Gioele Casola*, Christian Siegmund, Markus Mattern, Hirokazu Sugiyama "Integrated process performance assessment considering uncertainty in biopharmaceutical manufacturing operations" Oral, 27th European Symposium on Computer Aided Process Engineering (ESCAPE-27), 1-5 October 2017, Fira de Barcelona, Barcelona, Spain.
28.	Kensaku Matsunami*, Takuya Miyano, Hiroaki Arai, Hiroshi Nakagawa, Masahiko Hirao, Hirokazu Sugiyama "Selection support methodology between batch and continuous technologies for pharmaceutical tablet manufacturing processes" Oral, 2016 AIChE Annual Meeting, 13-18 November 2016, Hilton San Francisco Union Square, San Francisco, U.S.A.
27.	Gioele Casola*, Christian Siegmund, Markus Mattern, Hirokazu Sugiyama "Monte carlo simulation-based method for process performance assessment in sterile manufacturing of biopharmaceuticals" Poster, 2016 AIChE Annual Meeting, 13-18 November 2016, Hilton San Francisco Union Square, San Francisco, U.S.A.
26.	Keisho Yabuta*, Haruka Futamura, Koji Kawasaki, Masahiko Hirao, Hirokazu Sugiyama "Developing process models of hydrogen peroxide decontamination in pharmaceutical manufacturing" Poster, 2016 AIChE Annual Meeting, 13-18 November 2016, Hilton San Francisco Union Square, San Francisco, U.S.A.
25.	Hirokazu Sugiyama* "Design problem of pharmaceutical manufacturing processes" Oral, 2016 AIChE Annual Meeting, 13-18 November 2016, Hilton San Francisco Union Square, San Francisco, U.S.A.
24.	Kensaku Matsunami*, Takuya Miyano, Hiroaki Arai, Hiroshi Nakagawa, Masahiko Hirao, Hirokazu Sugiyama "Design method for pharmaceutical tablet production considering batch & continuous technologies" Oral, The 7th International Symposium on Design, Operation & Control of Chemical Processes (PSE Asia 2016), 24-27 July 2016, The University of Tokyo, Tokyo, Japan.
23.	Keisho Yabuta*, Masahiko Hirao, Hirokazu Sugiyama "Process model of sterile drug product manufacturing for yield enhancement" Oral, The 7th International Symposium on Design, Operation & Control of Chemical Processes (PSE Asia 2016), 24-27 July 2016, The University of Tokyo, Tokyo, Japan.
22.	Haruku Shirahata*, Masahiko Hirao, Hirokazu Sugiyama "Selection support method of single-use vs. multi-use technologies in sterile drug product manufacturing" Oral, The 7th International Symposium on Design, Operation & Control of Chemical Processes (PSE Asia 2016), 24-27 July 2016, The University of Tokyo, Tokyo, Japan.
21.	Masaaki Ito*, Yasuyuki Yoshioka, Hayao Nakanishi, Masahiko Hirao, Hirokazu Sugiyama "Product loss reduction in batch manufacturing of sterile drug products" Oral, The 7th International Symposium on Design, Operation & Control of Chemical Processes (PSE Asia 2016), 24-27 July 2016, The University of Tokyo, Tokyo, Japan.
20.	Lukas Eberle*, Hirokazu Sugiyama, Stavros Papadokonstantakis, Andreas Graser, Rainer Schmidt, Konrad Hungerbühler "Data-driven approach for increasing yield in drug product manufacturing" Oral, The 7th International Symposium on Design, Operation & Control of Chemical Processes (PSE Asia 2016), 24-27 July 2016, The University of Tokyo, Tokyo, Japan.
19.	Gioele Casola*, Christian Siegmund, Markus Mattern, Hirokazu Sugiyama "Creating hybrid-model-based simulation environment for sterile drug product manufacturing" Oral, The 7th International Symposium on Design, Operation & Control of Chemical Processes (PSE Asia 2016), 24-27 July 2016, The University of Tokyo, Tokyo, Japan.
18.	Hirokazu Sugiyama* "Conducting process systems engineering research on pharmaceutical manufacturing" Oral, The 7th International Symposium on Design, Operation & Control of Chemical Processes (PSE Asia 2016), 24-27 July 2016, The University of Tokyo, Tokyo, Japan.
17.	Hirokazu Sugiyama, Akiko Segawa*, Satoshi Yoshikawa, Takayuki Toyama, Hayao Nakanishi, Emi Kikuchi-Uehara, Masahiko Hirao "Multiobjective retrofitting methodology for manufacturing processes of active pharmaceutical ingredients considering environment, health and safety risks" Oral, 26th European Symposium on Computer Aided Process Engineering (ESCAPE-26), 12-15 June 2016, Grand Hotel Bernardin Congress Centre, Portorož, Slovenia.
16.	Gioele Casola*, Lukas Eberle, Christian Siegmund, Markus Mattern, Hirokazu Sugiyama "Mid-term scheduling model based on state-task netwotk for considering plant specific constraints in pharmaceutical manufacturing" Poster, 26th European Symposium on Computer Aided Process Engineering (ESCAPE-26), 12-15 June 2016, Grand Hotel Bernardin Congress Centre, Portorož, Slovenia.
15.	Lukas Eberle*, Elisabet Capon, Hirokazu Sugiyama, George Tien, Andreas Graser, Rainer Schmidt, Konrad Hungerbühler "Modeling liquid drug product manufacturing: method and case study" Oral, AIChE annual meeting 2015, 8–13 November 2015, Marriott Salt Lake City Downtown, Salt Lake City, Utah, U.S.A.
14.	Gioele Casola*, Satoshi Yoshikawa, Hayao Nakanishi, Masahiko Hirao, Hirokazu Sugiyama "Systematic retrofitting methodology for pharmaceutical drug purification processes" Oral, AIChE annual meeting 2015, 8–13 November 2015, Salt Palace Convention Center, Salt Lake City, Utah, U.S.A.
13.	Hirokazu Sugiyama* "The role of modeling, simulation and optimization approaches in the design of pharmaceutical production processes" Oral, AIChE annual meeting 2015, 8–13 November 2015, Salt Palace Convention Center, Salt Lake City, Utah, U.S.A.
12.	Haruku Shirahata*, Masahiko Hirao, Hirokazu Sugiyama "Systems Engineering Approaches for Designing Pharmaceutical Manufacturing Processes" Oral, AIChE annual meeting 2015, 8–13 November 2015, Salt Palace Convention Center, Salt Lake City, Utah, U.S.A.
11.	Lukas Eberle*, Hirokazu Sugiyama, Stavros Papadokonstantakis, Andreas Graser, Rainer Schmidt, Konrad Hungerbühler "Improving yield of drug product manufacturing with hybrid approach" Oral, AIChE annual meeting 2015, 8–13 November 2015, Salt Palace Convention Center, Salt Lake City, Utah, U.S.A.
10.	Hirokazu Sugiyama* "Systems Engineering Approaches for Designing Pharmaceutical Manufacturing Processes" Oral [invited], Pharma Process Forum, 27–28 October 2015, Palau de Congressos, Barcelona, Spain
9.	Lukas Gallus Eberle*, Elisabet Capón-Garcia, Martin Senninger, Hirokazu Sugiyama, Andreas Graser, Rainer Schmidt, Konrad Hungerbühler "Optimal scheduling of liquid drug product manufacturing" Oral, 12th International Symposium on Process Systems Engineering and 25th European Symposium on Computer Aided Process Engineering (PSE 2015 & ESCAPE-25), 31 May – 4 June 2015, Bella Center, Copenhagen, Denmark
8.	Lukas Gallus Eberle*, Hirokazu Sugiyama, Stavros Papadokonstantakis, Andreas Graser, Rainer Schmidt, Konrad Hungerbühler "Improving pharmaceutical batch production processes with data-based tiered approach" Poster, 12th International Symposium on Process Systems Engineering and 25th European Symposium on Computer Aided Process Engineering (PSE 2015 & ESCAPE-25), 31 May – 4 June 2015, Bella Center, Copenhagen, Denmark
7.	Gioele Casola*, Hirokazu Sugiyama, Satoshi Yoshikawa, Hayao Nakanishi, Masahiko Hirao "Systematic retrofitting methodology for recrystallization of thermally unstable active pharmaceutical ingredients" Poster, 12th International Symposium on Process Systems Engineering and 25th European Symposium on Computer Aided Process Engineering (PSE 2015 & ESCAPE-25), 31 May – 4 June 2015, Bella Center, Copenhagen, Denmark
6.	Hirokazu Sugiyama*, Masahiko Hirao "Process-based method for reducing product losses in pharmaceutical manufacturing" Oral, 12th International Symposium on Process Systems Engineering and 25th European Symposium on Computer Aided Process Engineering (PSE 2015 & ESCAPE-25), 31 May – 4 June 2015, Bella Center, Copenhagen, Denmark
5.	Hirokazu Sugiyama* "Process-based approaches for improving product yield in sterile drug product manufacturing" 2014 Annual Meeting of ISPE, October 12–15 2014, Caesers Palace, Las Vegas, USA
4.	Lukas Gallus Eberle*, Hirokazu Sugiyama, Stavros Papadokonstantakis, Andreas Graser, Rainer Schmidt, Konrad Hungerbühler "Data-based approach for efficient yield enhancement in pharma production" Oral, 24th European Symposium on Computer Aided Process Engineering (ESCAPE-24), 15–18 June 2014, Hungarian Academy of Sciences, Budapest, Hungary
3.	Hirokazu Sugiyama*, Masahiko Hirao "Integration framework for improving quality and cost-effectiveness in pharmaceutical production processes" Oral, 24th European Symposium on Computer Aided Process Engineering (ESCAPE-24), 15–18 June 2014, Hungarian Academy of Sciences, Budapest, Hungary
2.	Hirokazu Sugiyama*, Sandra Schinzel, Georg Müller, Rainer Schmidt "Applying process systems engineering for continuous improvement in pharmaceutical production" Oral, 12th International Symposium on Process Systems Engineering (PSE 2013), 25–27 June 2013, Putra World Trade Centre (PWTC), Kuala Lumpur, Malaysia
1.	Lukas Gallus Eberle*, Hirokazu Sugiyama, Rainer Schmidt "Improving lead time of sterile drug product manufacturing using Monte Carlo simulation" Poster, 23rd European Symposium on Computer Aided Process Engineering (ESCAPE-23), 9–12 June 2013, Lappeenranta University of Technology, Lappeenranta, Finland

Domestic conferences

103.	Badr Sara, Okamura Kozue, Takahashi Nozomi, Sugiyama Hirokazu "Assessment of robustness and operational considerations for the design of integrated mAb manufacturing processes" Oral, Society of Chemical Engineers, Japan (SCEJ) 86th Annual Meeting, 20-22 March 2021, Virtual meeting
102.	Zeberli Anicia, Badr Sara, Siegmund Christian, Mattern Markus, Sugiyama Hirokazu "Data-driven anomaly detection, prognostics and diagnostics for operation support in biopharmaceutical manufacturing" Oral, Society of Chemical Engineers, Japan (SCEJ) 86th Annual Meeting, 20-22 March 2021, Virtual meeting
101.	Zuercher Philipp Samuel, Badr Sara, Sugiyama Hirokazu "Data-driven approaches towards equipment health classification using process monitoring information in pharmaceutical manufacturing" Oral, Society of Chemical Engineers, Japan (SCEJ) 86th Annual Meeting, 20-22 March 2021, Virtual meeting
100.	Yusuke Hayashi, Kota Oishi, Hirokazu Sugiyama "Cost-effectiveness analysis of allogeneic induced pluripotent cell therapy using agent-based models" Oral, Society of Chemical Engineers, Japan (SCEJ) 86th Annual Meeting, 20-22 March 2021, Virtual meeting
99.	Kozue Okamura, Sara Badr, Hirokazu Sugiyama "Hybrid modeling of cell cultivation towards integrated design of monoclonal antibody production processes" Poster, Student Award (Poster), Society of Chemical Engineers, Japan (SCEJ) 86th Annual Meeting, 20-22 March 2021, Virtual meeting
98.	Nozomi Takahashi, Sara Badr, Hirokazu Sugiyama "Robust design of capture chromatography processes in monoclonal antibody production" Poster, Society of Chemical Engineers, Japan (SCEJ) 86th Annual Meeting, 20-22 March 2021, Virtual meeting
97.	Hirokazu Sugiyama "Rolls and challenges of Quality by Design in cell manufacturing" Oral, The 20th Congress of the Japanese Society for Regenerative Medicine (JSRM), 11-13 March 2021, Virtual meeting
96.	Yusuke Hayashi, Benedikt Scholz, Hirokazu Sugiyama "Computational fluid dynamics simulation-based scale-up of slow freezing processes for human induced pluripotent stem cells" Oral, The 20th Congress of the Japanese Society for Regenerative Medicine (JSRM), 11-13 March 2021, Virtual meeting
95.	Yusuke Hayashi, Ikki Horiguchi, Masahiro Kino-oka, Hirokazu Sugiyama "Life cycle design of packaging based on environmental and functional Simulation-based optimization of temperature profiles in slow freezing of hiPS cells" Oral, Society of Chemical Engineers, Japan (SCEJ) 51st Autumn Meeting, 24-26 September 2020, Virtual meeting
94.	Masahiro Yamada, Yasuyuki Yoshioka, Hayao Nakanishi, Hirokazu Sugiyama "Design method for injectable manufacturing processes considering continuous and batch modes" Oral, Society of Chemical Engineers, Japan (SCEJ) 51st Autumn Meeting, 24-26 September 2020, Virtual meeting
93.	Anicia Zeberli, Sara Badr, Christian Siegmund, Markus Mattern, Hirokazu Sugiyama "Data-driven failure detection and root-cause analysis in changeover processes in biopharmaceutical drug product manufacturing" Oral, Society of Chemical Engineers, Japan (SCEJ) 51st Autumn Meeting, 24-26 September 2020, Virtual meeting
92.	Kensaku Matsunami, Ingmar Nopens, Hirokazu Sugiyama, Thomas De Beer "Analysis of the effects of process parameters on start-up operation in continuous wet granulation" Oral, The Research Encouragement Prize of the Division of SIS, Society of Chemical Engineers, Japan (SCEJ) 51st Autumn Meeting, 24-26 September 2020, Virtual meeting
91.	Haruku Shirahata, Sara Badr, Hirokazu Sugiyama "Holistic design of biopharmaceutical production processes considering single-use technology and continuous manufacturing" Oral, Society of Chemical Engineers, Japan (SCEJ) 51st Autumn Meeting, 24-26 September 2020, Virtual meeting
90.	Hirokazu Sugiyama [Requested talk] "Systems med&pharma: as a new section in SIS division and a new field" Oral, Society of Chemical Engineers, Japan (SCEJ) 51st Autumn Meeting, 24-26 September 2020, Virtual meeting
89.	Junu Kim, Hironori Yonekura, Takeaki Watanabe, Satoshi Yoshikawa, Hayao Nakanishi, Hirokazu Sugiyama "Decision support method for the choice between batch and flow syntheses in drug substance manufacturing" Oral, Society of Chemical Engineers, Japan (SCEJ) 51st Autumn Meeting, 24-26 September 2020, Virtual meeting
88.	Yusuke Hayashi, Benedikt Scholz, Hirokazu Sugiyama "Scale-up of slow freezing processes for hiPS cells using CFD simulation" Abstract, Society of Chemical Engineers, Japan (SCEJ) 85th Annual Meeting, 2020
87.	Keisho Yabuta, Haruka Futamura, Koji Kawasaki, Hirokazu Sugiyama "Model-based design of H2O2 decontamination processes in sterile drug product manufacturing" Abstract, Society of Chemical Engineers, Japan (SCEJ) 85th Annual Meeting, 2020
86.	Haruku Shirahata, Sara Badr, Hirokazu Sugiyama "Holistic design of biopharmaceutical production processes considering single-use technology and continuous manufacturing" Abstract, Society of Chemical Engineers, Japan (SCEJ) 85th Annual Meeting, 2020
85.	Kensaku Matsunami, Ingmar Nopens, Hirokazu Sugiyama, Thomas De Beer "Analysis of the effects of process parameters on start-up operation in continuous wet granulation" Abstract, Society of Chemical Engineers, Japan (SCEJ) 85th Annual Meeting, 2020
84.	Kozue Okamura, Sara Badr, Hirokazu Sugiyama "Process simulation for the decision making on cell cultivation modes in monoclonal antibody production" Abstract, Society of Chemical Engineers, Japan (SCEJ) 85th Annual Meeting, 2020
83.	Yusuke Hayashi, Ikki Horiguchi, Masahiro Kino-oka, Hirokazu Sugiyama "Simulation-based optimization of temperature profiles in slow freezing of hiPS cells" Abstract, Society of Chemical Engineers, Japan (SCEJ) 85th Annual Meeting, 2020
82.	Junu Kim, Hironori Yonekura, Takeaki Watanabe, Satoshi Yoshikawa, Hayao Nakanishi, Hirokazu Sugiyama "Decision support method for the choice between batch and flow syntheses in drug substance manufacturing" Abstract, Society of Chemical Engineers, Japan (SCEJ) 85th Annual Meeting, 2020
81.	Masahiro Yamada, Yasuyuki Yoshioka, Hayao Nakanishi, Hirokazu Sugiyama "Design method for injectable manufacturing processes considering continuous and batch modes" Abstract, Society of Chemical Engineers, Japan (SCEJ) 85th Annual Meeting, 2020
80.	Yusuke Hayashi*, Ikki Horiguchi, Masahiro Kino-oka, Hirokazu Sugiyama "数理モデルを用いたヒトiPS細胞緩慢凍結プロセスの動的最適化" Abstract, The 19th Congress of the Japanese Society for Regenerative Medicine (JSRM), 2020
79.	Anicia Zeberli* "Data-driven operation support" Oral, ISPE Japan Affiliate Annual Meeting 2019, 30-31 May 2019, Tower Hall Funabori, Tokyo
78.	Yusuke Hayashi* "Process design of iPS cell freezing" Oral, ISPE Japan Affiliate Annual Meeting 2019, 30-31 May 2019, Tower Hall Funabori, Tokyo
77.	Haruku Shirahata* "Selection of single-use vs multi-use" Oral, ISPE Japan Affiliate Annual Meeting 2019, 30-31 May 2019, Tower Hall Funabori, Tokyo
76.	Masahiro Yamada* "Lot-size determination in injectable manufacturing" Oral, ISPE Japan Affiliate Annual Meeting 2019, 30-31 May 2019, Tower Hall Funabori, Tokyo
75.	Kensaku Matsunami* "Continuous manufacturing of solid drug products" Oral, ISPE Japan Affiliate Annual Meeting 2019, 30-31 May 2019, Tower Hall Funabori, Tokyo
74.	Kozue Okamura* "Continuous manufacturing of biopharmaceuticals" Oral, ISPE Japan Affiliate Annual Meeting 2019, 30-31 May 2019, Tower Hall Funabori, Tokyo
73.	Hirokazu Sugiyama* "Smart manufacturing and nexus problem of drugs" Oral, ISPE Japan Affiliate Annual Meeting 2019, 30-31 May 2019, Tower Hall Funabori, Tokyo
72.	Sara Badr*, Kozue Okamura, Nozomi Takahashi, Haruku Shirahata, Hirokazu Sugiyama "Design and assessment of process alternatives for integrated monoclonal antibody production: Opportunities for continuous manufacturing" Oral, The Research Encouragement Prize of the Division of SIS, SCEJ 84th Annual Meeting, 13-15 March 2019, Shibaura Institute of Technology, Tokyo
71.	Haruku Shirahata*, Yuki Shinno, Shuta Hagimori, Sara Badr, Hirokazu Sugiyama "Online decision-support tool for the equipment technology choice in parenterals manufacturing of biopharmaceuticals" Oral, SCEJ 84th Annual Meeting, 13-15 March 2019, Shibaura Institute of Technology, Tokyo
70.	Kensaku Matsunami*, Shuichi Tanabe, Keita Yaginuma, Hirokazu Sugiyama "Economic evaluation of solid drug product manufacturing processes considering the choice of continuous manufacturing" Oral, Technical Achievement Award of the Division of SIS, SCEJ 84th Annual Meeting, 13-15 March 2019, Shibaura Institute of Technology, Tokyo
69.	Hirokazu Sugiyama*, Kozue Okamura, Nozomi Takahashi, Haruku Shirahata, Sara Badr "Simulation and assessment of monoclonal antibody production processes considering continuous manufacturing" Oral, SCEJ 84th Annual Meeting, 13-15 March 2019, Shibaura Institute of Technology, Tokyo
68.	Masaki Shiokaramatsu*, Kazuhiro Fukumori, Ikki Horiguchi, Masahiro Kino-oka, Hirokazu Sugiyama "Lot-sizing in suspended filling processes of human induced pluripotent stem cells" Poster, SCEJ 84th Annual Meeting, 13-15 March 2019, Shibaura Institute of Technology, Tokyo
67.	Koichi Hayashi*, Sara Badr, Hirokazu Sugiyama "Modeling and process assessment of batch and continuous manufacturing in API synthesis" Poster, SCEJ 84th Annual Meeting, 13-15 March 2019, Shibaura Institute of Technology, Tokyo
66.	Yusuke Hayashi*, Ikki Horiguchi, Masahiro Kino-oka, Hirokazu Sugiyama "Design of freezing processes for human induced pluripotent stemm cells towards industiral manufacturing" Poster, SCEJ 84th Annual Meeting, 13-15 March 2019, Shibaura Institute of Technology, Tokyo
65.	Nozomi Takahashi*, Sara Badr, Hirokazu Sugiyama "Simulation and design of chromatography columns in monoclonal antibody purification" Poster, SCEJ 84th Annual Meeting, 13-15 March 2019, Shibaura Institute of Technology, Tokyo
64.	Kozue Okamura*, Sara Badr, Hirokazu Sugiyama "Dynamic simulation and process assessment of cell cultivation modes in monoclonal antibody production" Poster, Student Award (Poster), SCEJ 84th Annual Meeting, 13-15 March 2019, Shibaura Institute of Technology, Tokyo
63.	Hirokazu Sugiyama*, Haruku Shirahata, Philipp Zuercher, Sara Badr "Models for supporting the choice between single-use and multi-use technologies in drug product manufacturing of biopharmaceuticals" Oral, Society of Chemical Engineers, Japan (SCEJ) 50th Autumn Meeting, 18-20 September 2018, Kagoshima University, Kagoshima
62.	Anicia Zeberli*, Sara Badr, Christian Siegmund, Markus Mattern, Hirokazu Sugiyama "Data-driven predictive monitoring and operation support for decontamination processes in biopharmaceutical manufacturing" Oral, Society of Chemical Engineers, Japan (SCEJ) 50th Autumn Meeting, 18-20 September 2018, Kagoshima University, Kagoshima
61.	Gioele Casola*, Christian Siegmund, Markus Mattern, Hirokazu Sugiyama "Framework for data-driven process improvement and operations support in biopharmaceutical drug product manufacturing" Oral, Society of Chemical Engineers, Japan (SCEJ) 50th Autumn Meeting, 18-20 September 2018, Kagoshima University, Kagoshima
60.	Yusuke Hayashi*, Ikki Horiguchi, Masahiro Kino-oka, Masahiko Hirao, Hirokazu Sugiyama "Freeze-thaw process design of induced pluripotent stem cells using mechanistic models" Oral, Society of Chemical Engineers, Japan (SCEJ) 50th Autumn Meeting, 18-20 September 2018, Kagoshima University, Kagoshima
59.	Kensaku Matsunami, Takuya Nagato, Koji Hasegawa, Masahiko Hirao, Hirokazu Sugiyama "Process evaluation models for continuous tablet manufacturing based on design of experiments" Oral, Society of Chemical Engineers, Japan (SCEJ) 50th Autumn Meeting, 18-20 September 2018, Kagoshima University, Kagoshima
58.	Masahiro Yamada*, Sara Badr, Shouko Fukuda, Manabu Nakaya, Yasuyuki Yoshioka, Masahiko Hirao, Hirokazu Sugiyama "Determination of lot-size in injectable manufacturing by the integrated use of process information" Oral, Society of Chemical Engineers, Japan (SCEJ) 50th Autumn Meeting, 18-20 September 2018, Kagoshima University, Kagoshima
57.	Hirokazu Sugiyama* [Invited lecture] "Decision-support tools for biopharmaceutical manufacturing"Design problem of pharmaceutical manufacturing processes" Oral, Society of Chemical Engineers, Japan (SCEJ) 83rd Annual Meeting, 13-15 March 2018, Kansai University, Osaka
56.	Shohei Fukuhara*, Osamu Nishidate, Shin Kikuchi, Yoshifumi Takahashi, Masahiko Hirao, Hirokazu Sugiyama "Method for reducing EHS risks in drug substance manufacturing considering process characteristics" Poster, Society of Chemical Engineers, Japan (SCEJ) 83rd Annual Meeting, 13-15 March 2018, Kansai University, Osaka
55.	Keisho Yabuta*, Haruka Futamura, Koji Kawasaki, Masahiko Hirao, Hirokazu Sugiyama "Development of models for designing decontamination processes in pharmaceutical manufacturing" Oral, Society of Chemical Engineers, Japan (SCEJ) 83rd Annual Meeting, 13-15 March 2018, Kansai University, Osaka
54.	Hirokazu Sugiyama* "Process systems engineering research for continuous drug manufacturing" Oral, Society of Chemical Engineers, Japan (SCEJ) 83rd Annual Meeting, 13-15 March 2018, Kansai University, Osaka
53.	Gioele Casola*, Christian Siegmund, Markus Mattern, Hirokazu Sugiyama "Data-driven approaches for process improvement and operation support in biopharmaceutical drug product manufacturing" Oral, Society of Chemical Engineers, Japan (SCEJ) 83rd Annual Meeting, 13-15 March 2018, Kansai University, Osaka
52.	Yusuke Hayashi*, Masahiro Kino-oka, Ikki Horiguchi, Masahiko Hirao, Hirokazu Sugiyama "Freeze-thaw process design for industrial manufacturing of induced pluripotent stem cells" Poster, Society of Chemical Engineers, Japan (SCEJ) 83rd Annual Meeting, 13-15 March 2018, Kansai University, Osaka
51.	Norikazu Harada*, Naohisa Yahagi, Masahiko Hirao, Hirokazu Sugiyama "Methodology for selecting reduction measures of unused medicine considering patient characteristics" Poster, Society of Chemical Engineers, Japan (SCEJ) 83rd Annual Meeting, 13-15 March 2018, Kansai University, Osaka
50.	Masahiro Yamada*, Yasuyuki Yoshioka, Manabu Nakaya, Shouko Fukuda, Masahiko Hirao, Hirokazu Sugiyama "Lot-sizing method in parenterals manufacturing processes based on economic evaluation" Poster, Society of Chemical Engineers, Japan (SCEJ) 83rd Annual Meeting, 13-15 March 2018, Kansai University, Osaka
49.	Kensaku Matsunami*, Masahiko Hirao, Hirokazu Sugiyama "Design method of solid drug product manufacturing processes in clinical development" Poster, Society of Chemical Engineers, Japan (SCEJ) 83rd Annual Meeting, 13-15 March 2018, Kansai University, Osaka
48.	Anicia Zeberli*, Thomas Roedl, Stephanie Knueppel, Christian Siegmund, Markus Mattern, Hirokazu Sugiyama "Big data-platform for supporting design and operation of biopharmaceutical decontamination processes" Poster, Society of Chemical Engineers, Japan (SCEJ) 83rd Annual Meeting, 13-15 March 2018, Kansai University, Osaka
47.	Haruku Shirahata*, Shant Dakessian, Masahiko Hirao, Hirokazu Sugiyama "Multi-layer and multi-objective design platform for parenterals manufacturing processes" Oral, Society of Chemical Engineers, Japan (SCEJ) 49th Autumn Meeting, 20-22 September 2017, Nagoya University, Aichi
46.	Kensaku Matsunami*, Takuya Nagato, Koji Hasegawa, Masahiko Hirao, Hirokazu Sugiyama "Product quality evaluation in batch and continuous manufacturing processes of pharmaceutical tablets" Oral, Society of Chemical Engineers, Japan (SCEJ) 49th Autumn Meeting, 20-22 September 2017, Nagoya University, Aichi
45.	Hirokazu Sugiyama* "Process synthesis in drug product manufacturing integrating equipment technology information" Oral, Society of Chemical Engineers, Japan (SCEJ) 49th Autumn Meeting, 20-22 September 2017, Nagoya University, Aichi
44.	Gioele Casola* "Model 4: Improvement of CIP/SIP processes considering uncertainty" Oral, ISPE Japan Affiliate Annual Meeting 2017 (15th Aniversary Meeting), 18-19 May 2017, Toyama International Conference Center, Toyama
43.	Kensaku Matsunami* "Model 3: Decision on the choice of continuous and batch technologies in solid drug product manufacturing" Oral, ISPE Japan Affiliate Annual Meeting 2017 (15th Aniversary Meeting), 18-19 May 2017, Toyama International Conference Center, Toyama
42.	Keisho Yabuta* "Model 2: Design of decontamination processes using hydrogen peroxide" Oral, ISPE Japan Affiliate Annual Meeting 2017 (15th Aniversary Meeting), 18-19 May 2017, Toyama International Conference Center, Toyama
41.	Haruku Shirahata* "Model 1: Decision on the choice of single- and multi-use technologies in sterile drug product manufacturing" Oral, ISPE Japan Affiliate Annual Meeting 2017 (15th Aniversary Meeting), 18-19 May 2017, Toyama International Conference Center, Toyama
40.	Hirokazu Sugiyama* "Background and objectives of the workshop" Oral, ISPE Japan Affiliate Annual Meeting 2017 (15th Aniversary Meeting), 18-19 May 2017, Toyama International Conference Center, Toyama
39.	Hirokazu Sugiyama* "再生医療製品の実生産に向けたプロセスシステム工学(In Japanese)" Oral, The 16th Congress of the Japanese Society for Regenerative Medicine, 7-9 March 2017, Sendai International Center, Miyagi
38.	Hirokazu Sugiyama* "Model-based design in the manufacturing of pharmaceuticals and regenerative medicine" Oral, Society of Chemical Engineers, Japan (SCEJ) 82nd Annual Meeting, 6-8 March 2017, Shibaura Institute of Technology, Tokyo
37.	Kensaku Matsunami*, Takuya Nagato, Koji Hasegawa, Masahiko Hirao, Hirokazu Sugiyama "Product quality evaluation of batch and continuous technologies in pharmaceutical tablet manufacturing processes" Poster, Society of Chemical Engineers, Japan (SCEJ) 82nd Annual Meeting, 6-8 March 2017, Shibaura Institute of Technology, Tokyo
36.	Masaki Shiokaramatsu*, Masahiro Kino-oka, Masahiko Hirao, Hirokazu Sugiyama "Design of working cell bank of allogeneic iPS cells using Monte Carlo simulation" Poster, Society of Chemical Engineers, Japan (SCEJ) 82nd Annual Meeting, 6-8 March 2017, Shibaura Institute of Technology, Tokyo
35.	Masaaki Ito*, Y. Akimoto, K. Takahashi, Y. Kato, N. Kikuchi, Masahiko Hirao, Hirokazu Sugiyama "Method for material loss reduction in drug product manufacturing processes" Poster, Society of Chemical Engineers, Japan (SCEJ) 82nd Annual Meeting, 6-8 March 2017, Shibaura Institute of Technology, Tokyo
34.	Anicia Zeberli*, Gioele Casola, Christian Siegmund, Markus Mattern, Hirokazu Sugiyama "Application of computational fluid dynamics for equipment redesign in sterile manufacturing of biopharmaceuticals" Poster, Society of Chemical Engineers, Japan (SCEJ) 82nd Annual Meeting, 6-8 March 2017, Shibaura Institute of Technology, Tokyo
33.	Keisho Yabuta*, Haruka Futamura, Koji Kawasaki, Masahiko Hirao, Hirokazu Sugiyama "Design methodology of decontamination processes using hydrogen peroxide in pharmaceutical manufacturing" Poster, Society of Chemical Engineers, Japan (SCEJ) 82nd Annual Meeting, 6-8 March 2017, Shibaura Institute of Technology, Tokyo
32.	Haruku Shirahata*, Masahiko Hirao, Hirokazu Sugiyama "Design methodology of parenterals manufacturing processes considering the choice between single-use and multi-use technologies" Poster, Student Award (Poster), Society of Chemical Engineers, Japan (SCEJ) 82nd Annual Meeting, 6-8 March 2017, Shibaura Institute of Technology, Tokyo
31.	Hirokazu Sugiyama* "Process systems engineering for pharmaceutical manufacturing" Oral, The 22nd SCEJ Symposium on Fluidization & Particle Processing, 8-9 December 2016, The University of Tokyo, Tokyo
30.	Gioele Casola*, Christian Siegmund, Markus Mattern, Hirokazu Sugiyama "Biopharmaceutical process optimization: needs and benefits of numerical simulation approaches" Poster, The 22nd SCEJ Symposium on Fluidization & Particle Processing, 8-9 December 2016, The University of Tokyo, Tokyo
29.	Kensaku Matsunami*, Takuya Miyano, Hiroaki Arai, Hiroshi Nakagawa, Masahiko Hirao, Hirokazu Sugiyama "Process systems approaches for pharmaceutical tablet manufacturing considering batch and continuous technologies" Poster, The 22nd SCEJ Symposium on Fluidization & Particle Processing, 8-9 December 2016, The University of Tokyo, Tokyo
28.	Hirokazu Sugiyama* "The role of integration engineering in bioprocess innovation" Oral [Invited lecture], Society of Chemical Engineers, Japan (SCEJ) 48th Autumn Meeting, 6-8 September 2016, Tokushima University, Tokushima
27.	Hirokazu Sugiyama* "Process systems engineering research on pharmaceutical continuous manufacturing" Oral, Society of Chemical Engineers, Japan (SCEJ) 48th Autumn Meeting, 6-8 September 2016, Tokushima University, Tokushima
26.	Gioele Casola, Christian Siegmund, Markus Mattern, Hirokazu Sugiyama "Process performance assessment based on stochastic simulation in sterile drug product manufacturing" Oral, Society of Chemical Engineers, Japan (SCEJ) 48th Autumn Meeting, 6-8 September 2016, Tokushima University, Tokushima
25.	Keisho Yabuta*, Haruka Futamura, Koji Kawasaki, Masahiko Hirao, Hirokazu Sugiyama "Developing process models of hydrogen peroxide decontamination in pharmaceutical manufacturing" Oral, Society of Chemical Engineers, Japan (SCEJ) 48th Autumn Meeting, 6-8 September 2016, Tokushima University, Tokushima
24.	Haruku Shirahata*, Masahiko Hirao, Hirokazu Sugiyama "Risk evaluation models for the design of parenterals manufacturing processes" Oral, Society of Chemical Engineers, Japan (SCEJ) 48th Autumn Meeting, 6-8 September 2016, Tokushima University, Tokushima
23.	Hirokazu Sugiyama* "Next steps of Pharma PSE research and expansion as COP" Oral, ISPE Japan Affiliate Annual Meeting 2016, 14- 15 April 2016, Tower Hall Funabori, Tokyo
22.	Akira Hashimoto* "Analyzing generation of unused medicine and its reduction support method" Oral, ISPE Japan Affiliate Annual Meeting 2016, 14- 15 April 2016, Tower Hall Funabori, Tokyo
21.	Haruku Shirahata* "Comparative evaluation of single-use and multi-use technologies as a process alternativet" Oral, ISPE Japan Affiliate Annual Meeting 2016, 14- 15 April 2016, Tower Hall Funabori, Tokyo
20.	Hirokazu Sugiyama* "Design problem of pharmaceutical manufacturing processes" Oral, Society of Chemical Engineers, Japan (SCEJ) 81st Annual Meeting, 13-15 March 2016, Kansai University, Osaka
19.	Kensaku Matsunami*, T. Miyano, H. Arai, H. Nakagawa, Masahiko Hirao, Hirokazu Sugiyama "Design method for pharmaceutical tablet production considering batch & continuous technologies" Poster, Student Award (Poster), Society of Chemical Engineers, Japan (SCEJ) 81st Annual Meeting, 13-15 March 2016, Kansai University, Osaka
18.	Menghe Xu, Mai Matsuura, Yusuke Morikawa, Hirokazu Sugiyama* "Designing solvent recovery processes in drug substance manufacturing" Poster, Student Award (Poster), Society of Chemical Engineers, Japan (SCEJ) 81st Annual Meeting, 13-15 March 2016, Kansai University, Osaka
17.	Hirokazu Sugiyama* "Process systems engineering as a design support tool for pharmaceutical production processes" Oral, Society of Chemical Engineers, Japan (SCEJ) 47th Autumn Meeting, 9-11 September 2015, Hokkaido University, Hokkaido
16.	Keisho Yabuta, Masahiko Hirao, Hirokazu Sugiyama* "Development of process models for enhancing yield in sterile drug product manufacturing" Oral, Society of Chemical Engineers, Japan (SCEJ) 47th Autumn Meeting, 9-11 September 2015, Hokkaido University, Hokkaido
15.	Hirokazu Sugiyama* "Frontier of engineering research on OPEX" Oral, ISPE Japan Affiliate Annual Meeting 2015, 16- 17 April 2015, Tower Hall Funabori, Tokyo
14.	Keisho Yabuta* "Process improvement in sterile drug product manufacturing using mathematical models" Oral, ISPE Japan Affiliate Annual Meeting 2015, 16- 17 April 2015, Tower Hall Funabori, Tokyo
13.	Haruku Shirahata* "Supporting method for the choice between single- and multi-use technologies in manufacturing sterile drug products" Oral, ISPE Japan Affiliate Annual Meeting 2015, 16- 17 April 2015, Tower Hall Funabori, Tokyo
12.	Hirokazu Sugiyama* "Modeling, simulation and optimization research for pharmaceutical manufacturing" Oral, SIS Division, the SCEJ Young Investigator Researcher Award, Society of Chemical Engineers, Japan (SCEJ) 80th Annual Meeting, 19-21 March 2015, Shibaura Institute of Technology, Tokyo
11.	Akiko Segawa*, Hirokazu Sugiyama, S. Yoshikawa, T. Toyama, H. Nakanishi, Masahiko Hirao "Method for reducing environmental, health and safety(EHS) risks in pharmaceutical drug substance manufacturing based on multiobjective evaluation" Poster, Student Award (Poster), Society of Chemical Engineers, Japan (SCEJ) 80th Annual Meeting, 19-21 March 2015, Shibaura Institute of Technology, Tokyo
10.	Keisho Yabuta*, Hirokazu Sugiyama, Masahiko Hirao "Construction of mathematical model for pharmaceutical batch process" Poster, Society of Chemical Engineers, Japan (SCEJ) 80th Annual Meeting, 19-21 March 2015, Shibaura Institute of Technology, Tokyo
9.	Haruku Shirahata*, Hirokazu Sugiyama, Masahiko Hirao "Supporting method for the choice between single-and multi-use technologies in manufacturing sterile drug products" Poster, Society of Chemical Engineers, Japan (SCEJ) 80th Annual Meeting, 19-21 March 2015, Shibaura Institute of Technology, Tokyo
8.	Takayuki Iida*, Kosuke Ota, Tomohito Sasozaki, Hirokazu Sugiyama "Multiobjective design method for use process of pharmaceutical ingredients considering quality and cost-effectiveness" Poster, Society of Chemical Engineers, Japan (SCEJ) 80th Annual Meeting, 19-21 March 2015, Shibaura Institute of Technology, Tokyo
7.	Gioele Casola*, Hirokazu Sugiyama, S. Yoshikawa, H. Nakanishi, Masahiko Hirao "Retrofitting methodology for pharmaceutical drug purification process using simulation technologies" Poster, Society of Chemical Engineers, Japan (SCEJ) 80th Annual Meeting, 19-21 March 2015, Shibaura Institute of Technology, Tokyo
6.	Hirokazu Sugiyama*, Lukas Gallus Eberle, Rainer Schmidt "Improving Lead Time of Pharmaceutical Production Processes Using Monte-Carlo Simulation" Oral, Society of Chemical Engineers, Japan (SCEJ) 46th Autumn Meeting, 17-19 September 2014, Kyushu University, Fukuoka
5.	Hirokazu Sugiyama* "Case Study 1 Methods for product loss reduction in sterile drug product manufacturing" Oral, ISPE Japan Affiliate Annual Meeting 2014, 10- 11 April 2014, Tower Hall Funabori, Tokyo
4.	Hirokazu Sugiyama* "Applying process systems engineering in pharmaceutical industry: a new paradigm" Oral [Invited Presentation], Society of Chemical Engineers, Japan (SCEJ) 79th Annual Meeting, 18-20 March 2014, Gifu University, Gifu
3.	Hirokazu Sugiyama*, Masaaki Ito, Masahiko Hirao "Process-based approaches for improving quality and cost-effectiveness in pharmaceutical manufacturing" Oral, Society of Chemical Engineers, Japan (SCEJ) 79th Annual Meeting, 18-20 March 2014, Gifu University, Gifu
2.	Masaaki Ito*, Hirokazu Sugiyama, Masahiko Hirao "Methods for supporing process improvement in pharmaceutical manufacturing" Poster, Society of Chemical Engineers, Japan (SCEJ) 79th Annual Meeting, 18-20 March 2014, Gifu University, Gifu
1.	Hirokazu Sugiyama* "Integration engineering towards better quality and productivity in pharmaceutical production processes" Oral [Keynote Lecture], Society of Chemical Engineers, Japan (SCEJ) 45th Autumn Meeting, 16-18 September 2013, Okayama University, Okayama

Software

・	SoliDecision This is a prototype tool that enables holistic economic assessment in solid drug product manufacturing.
・	TECHoice This is a prototype tool that enables comprehensive and quantitative evaluation of single-use and multi-use technologies in sterile filling processes of biopharmaceutical manufacturing.

Awards

・	Kozue Okamura Student Award (Poster), Society of Chemical Engineering of Japan, March 2021
・	Kensaku Matsunami Dean of the School of Engineering Award, The University of Tokyo, March 2021
・	Kozue Okamura Dean of the School of Engineering Award, The University of Tokyo, March 2021
・	Shungo Matsueda Dean of the Faculty of Engineering Award, The University of Tokyo, March 2021
・	Kozue Okamura Best presentation award, Graduate School of Engineering, Department of Chemical System Engineering, The University of Tokyo, March 2021
・	Kensaku Matsunami The Research Encouragement Prize of the Division of SIS, Society of Chemical Engineering of Japan, November 2020
・	Haruku Shirahata Dean of the School of Engineering Award, The University of Tokyo, March 2020
・	Sara Badr The Research Encouragement Prize of the Division of SIS, Society of Chemical Engineering of Japan, April 2019
・	Kensaku Matsunami, Shuichi Tanabe, Keita Yaginuma, Hirokazu Sugiyama Technical Achievement Award of the Division of SIS, Society of Chemical Engineering of Japan, April 2019
・	Yusuke Hayashi Best presentation award, Graduate School of Engineering, Department of Chemical System Engineering, The University of Tokyo, March 2019
・	Kozue Okamura Student Award (Poster), Society of Chemical Engineering of Japan, March 2019
・	Hirokazu Sugiyama, Particle Design Award, the New Pharmaceutical Technology and Engineering Foundation, March 2019
・	Gioele Casola Young Investigator Researcher Award of the Division of SIS, Society of Chemical Engineering of Japan, October 2018
・	Kensaku Matsunami Dean of the School of Engineering Award, The University of Tokyo, March 2018
・	Kensaku Matsunami Best presentation award, Graduate School of Engineering, Department of Chemical System Engineering, The University of Tokyo, March 2018
・	Kensaku Matsunami Student Award (Poster), Society of Chemical Engineering of Japan, March 2018
・	Haruku Shirahata Best presentation award, Graduate School of Engineering, Department of Chemical System Engineering, The University of Tokyo, March 2017
・	Haruku Shirahata Student Award (Poster), Society of Chemical Engineering of Japan, March 2017
・	Keisho Yabuta Excellent Student-Paper Award, PSE Asia 2016, August 2016
・	Haruku Shirahata Excellent Student-Paper Award, PSE Asia 2016, August 2016
・	Menghe Xu Student Award (Poster), Society of Chemical Engineering of Japan, March 2016
・	Kensaku Matsunami Student Award (Poster), Society of Chemical Engineering of Japan, March 2016
・	Hirokazu Sugiyama Young Investigator Researcher Award of the Division of SIS, Society of Chemical Engineering of Japan, April 2015
・	Akiko Segawa Student Award (Poster), Society of Chemical Engineering of Japan, March 2015