2025

1. Keita Hirono, Yusuke Hayashi, Yuuki Ogawa, Masahiro Kino-oka, Hirokazu Sugiyama
   "A Mathematical Model for Determining Probabilistic Design Space in Mesenchymal Stem Cell Passage Culture"
   Biotechnology & Bioengineering, Accepted
2. Gianluca Lombardini, Sara Badr, Christian Schmid, Stephanie Knüppel,Hirokazu Sugiyama
   "Anomaly detection for drug product manufacturing considering data limitations and shifts: A case study on industrial freeze-dryers"
   Computers & Chemical Engineering, 198, 109106
3. Yusuke Hayashi, Saho Okazaki, Kazuya Tanabe, Takuya Nagato, Hirokazu Sugiyama
   "Development of Concentration-Prediction Models in Multiple Manufacturing Environments Using NIR Spectroscopy"
   Journal of Chemical Engineering of Japan, 58, 2466828
4. Junu Kim, Kozue Okamura, Mohamed Rami Gaddem, Yusuke Hayashi, Sara Badr, Hirokazu Sugiyama
   "Impact of modeling and simulation on pharmaceutical process development"
   Current Opinion in Chemical Development, 47, 101093

2024

1. Kozue Okamura, Kota Oishi, Sara Badr, Akira Yamada, Hirokazu Sugiyama
   "Data-driven parameterization and development of mechanistic cell cultivation models in monoclonal antibody production processes: Shifts in cell metabolic behavior"
   Computers & Chemical Engineering, Accepted
2. Kosuke Nemoto, Yusuke Hayashi, Hirokazu Sugiyama
   "Indicator-based assessment of potential supply risks for pharmaceutical excipients: Method and application"
   International Journal of Pharmaceutics, Accepted
3. Benedikt X. Scholz, Yusuke Hayashi, Yuka Higashi, Yuki Uno, Mohamed Rami Gaddem, Masahiro Kino-oka, Hirokazu Sugiyama
   "Computational Fluid Dynamics Model-based Design of Continuous Forced Convection Freezing Processes for Human Induced Pluripotent Stem Cells Considering Supercooling of Extracellular Solutions"
   Chemical Engineering Research and Design, Accepted
4. Kozue Okamura, Sara Badr, Yusuke Ichida, Akira Yamada, Hirokazu Sugiyama
   “Modeling of cell cultivation for monoclonal antibody production processes considering lactate metabolic shifts”
   Biotechnology progresss, Accepted
5. Mohamed Rami Gaddem, Yusuke Hayashi, Benedikt Scholz, Haruka Futamura, Koji Kawasaki, Hirokazu Sugiyama
   “Model-based investigation of a novel decontamination technology: Ultrasound assisted aerosolized hydrogen peroxide”
   Chemical Engineering Research and Design , 205, 517–528 (2024)
6. Mohamed Rami Gaddem, Junu Kim, Kensaku Matsunami, Yusuke Hayashi, Sara Badr, Hirokazu Sugiyama
   “Roles of mechanistic, data-driven, and hybrid modeling approaches for pharmaceutical process design and operation”
   Current Opinion in Chemical Engineering , 44 (2024)
7. Keita Hirono, Yusuke Hayashi, Isuru A. Udugama, Yuto Takemoto, Ryuji Kato, Masahiro Kinooka, Hirokazu Sugiyama “Image-based hybrid model incorporating initial spatial distribution for mesenchymal stem cell cultivation process design”
   AIChE Journal, Accepted
8. Junu Kim, Yusuke Hayashi, Sara Badr, Kazuya Okamoto, Toshikazu Hakogi, Haruo Furukawa, Satoshi Yoshikawa, Hayao Nakanishi, Hirokazu Sugiyama
   "Kinetic study and model-based design space determination for a drug substance flow synthesis using amination reaction via nucleophilic aromatic substitution"
   Organic Process Research & Development, 28, 5, 1793–1805 (2024)
9. Yusuke Hayashi, Yuki Uno, Masahiro Kino-oka, Hirokazu Sugiyama
   “Computer-aided exploration of multiobjective optimal temperature profiles in slow freezing for human induced pluripotent stem cells”
   Cryobiology, 115, 104885 (2024)
10. Junu Kim, Kensaku Matsunami, Yusuke Ichida, Kozue Okamura, Sara Badr, Hirokazu Sugiyama
    "Scenario analysis of vaccine supply for COVID-19 in Japan using mathematical models of infectious diseases"
    Journal of Chemical Engineering of Japan, 57 (2024)

2023

1. Kozue Okamura, Hiroki Tsuchiya, Risa Hamada, Yusuke Hayashi, Sara Badr, Seiichi Ohta, Hirokazu Sugiyama
   "A systems evaluation model for the development of companion diagnostics and associated molecularly targeted therapies"
   Journal of Pharmaceutical Innovation, 199, 507–514 (2023)
2. Junu Kim, Yusuke Hayashi, Sara Badr, Kazuya Okamoto, Toshikazu Hakogi, Haruo Furukawa, Satoshi Yoshikawa, Hayao Nakanishi, and Hirokazu Sugiyama
   "Hybrid Modeling of an Active Pharmaceutical Ingredient Flow Synthesis in a Ring-Opening Reaction of an Epoxide with a Grignard Reagent"
   Industrial & Engineering Chemistry Research, 62, 43, 17824–17834 (2023)
3. Yusuke Hayashi, Saho Okazaki, Kensaku Matsunami, Kazuya Tanabe, Takuya Nagato, Hirokazu Sugiyama
   "Development of concentration prediction models for personalized tablet manufacturing using near-infrared spectroscopy"
   Chemical Engineering Research and Design, 199, 507–514 (2023)
4. Junu Kim, Yusuke Hayashi, Sara Badr, Kazuya Okamoto, Toshikazu Hakogi, Haruo Furukawa, Satoshi Yoshikawa, Hayao Nakanishi, Hirokazu Sugiyama
   "Mechanistic insights into the amination via nucleophilic aromatic substitution"
   Reaction Chemistry & Engineering, 8, 2060–2070 (2023)
5. Masahiro Yamada, Sara Badr, Yusuke Hayashi, Kenichi Zenitani, Kokichi Kubota, Hayao Nakanishi, Hirokazu Sugiyama
   "A comprehensive design approach for injectable manufacturing processes considering new technologies and operational aspects"
   Journal of Chemical Engineering of Japan, 56, 2201310 (2023)
6. Benedikt X. Scholz, Yusuke Hayashi, Isuru A. Udugama, Masahiro Kino-oka, Hirokazu Sugiyama
   "A CFD model-based design of seeding processes for two-dimensional mesenchymal stem cell cultivation"
   Computers & Chemical Engineering, 171, 108157 (2023)
7. Isuru A. Udugama, Sara Badr, Keita Hirono, Benedikt X. Scholz, Yusuke Hayashi, Masahiro Kino-oka, Hirokazu Sugiyama
   "The Role of Process Systems Engineering in Applying Quality by Design (QbD) in Mesenchymal Stem Cell Production"
   Computers & Chemical Engineering, 172, 108144 (2023)
8. Yusuke Hayashi, Akinori Shigeyama, Hirokazu Sugiyama
   "A screening support method of cryoprotective agents for regenerative medical products considering environmental impacts"
   Chemical Engineering Research and Design, 191, 83–92 (2023)
9. Kensaku Matsunami, Tomohiro Miura, Keita Yaginuma, Shuichi Tanabe, Sara Badr, Hirokazu Sugiyama
   "Surrogate modeling of dissolution behavior toward efficient design of tablet manufacturing processes"
   Computers & Chemical Engineering, 171, 108141 (2023)
10. Junu Kim, Yusuke Hayashi, Sara Badr, Hayao Nakanishi, Hirokazu Sugiyama
    "Impact of solvent selection on batch and flow syntheses for heterogeneous hydrogenation in drug substance manufacturing: A model-based analysis"
    Chemical Engineering Research and Design, 189, 156–166 (2023)

2022

1. Kozue Okamura, Sara Badr, Sei Murakami, Hirokazu Sugiyama
   "Hybrid Modeling of CHO Cell Cultivation in Monoclonal Antibody Production with an Impurity Generation Module"
   Industrial & Engineering Chemistry Research, 61, 14898–14909 (2022)
2. Philipp Zürcher, Sara Badr, Stephanie Knüppel, Hirokazu Sugiyama
   "Data-driven approach towards long-term equipment condition assessment in sterile drug product manufacturing"
   ACS Omega, 7, 36415–36426 (2022)
3. Philipp Zürcher, Sara Badr, Stephanie Knüppel, Hirokazu Sugiyama
   "Data-driven equipment condition monitoring and reliability assessment for sterile drug product manufacturing: method and application for an operating facility"
   Chemical Engineering Research and Design, 188, 301–314 (2022)
4. Fabian S. F. Hartmann, Isuru A. Udugama, Gerd M. Seibold, Hirokazu Sugiyama, Krist V. Gernaey
   "Digital models in biotechnology: Towards multi-scale integration and implementation"
   Biotechnology Advances, 60, 108015 (2022)
5. Benedikt X. Scholz, Yusuke Hayashi, Isuru A. Udugama, Masahiro Kino-oka, Hirokazu Sugiyama
   "A multilayered approach to scale-up forced convection-based freezing of human induced pluripotent stem cells"
   Computers & Chemical Engineering, 163, 107851 (2022)
6. Keita Hirono, Isuru A. Udugama, Yusuke Hayashi, Masahiro Kino-oka, Hirokazu Sugiyama
   "A dynamic and probabilistic design space determination method for mesenchymal stem cell cultivation processes"
   Industrial & Engineering Chemistry Research, 61, 7009–7019 (2022)
7. Yusuke Hayashi, Kota Oishi, Hirokazu Sugiyama
   "Cost-effectiveness analysis in the manufacture of allogeneic human induced pluripotent cells in Japan by agent-based modeling"
   Chemical Engineering Research and Design, 182, 172–182 (2022)
8. Masahiro Yamada, Sara Badr, Isuru A. Udugama, Shouko Fukuda, Manabu Nakaya, Yasuyuki Yoshioka, Hirokazu Sugiyama
   "A systematic techno-economic approach to decide between continuous and batch operation modes for injectable manufacturing"
   International Journal of Pharmaceutics, 613, 121353 (2022)
9. Yusuke Hayashi, Masahiro Kino-oka, Hirokazu Sugiyama
   "Hybrid-model-based design of fill-freeze-thaw processes for human induced pluripotent stem cells considering productivity and quality"
   Computers & Chemical Engineering, 156, 107566 (2022)
10. Junu Kim, Hironori Yonekura, Takeaki Watanabe, Satoshi Yoshikawa, Hayao Nakanishi, Sara Badr, Hirokazu Sugiyama
    "Model-based comparison of batch and flow syntheses of an active pharmaceutical ingredient using heterogeneous hydrogenation"
    Computers & Chemical Engineering, 156, 107541 (2022)

2021

1. Eri Amasawa, Hiroaki Kuroda, Kozue Okamura, Sara Badr, and Hirokazu Sugiyama
   "Cost–Benefit Analysis of Monoclonal Antibody Cultivation Scenarios in Terms of Life Cycle Environmental Impact and Operating Cost"
   ACS Sustainable Chemistry & Engineering, 9, 14012–14021 (2021)
2. Kensaku Matsunami, Alexander Ryckaert, Michiel Peeters, Sara Badr, Hirokazu Sugiyama, Ingmar Nopens, Thomas De Beer
   "Analysis of the Effects of Process Parameters on Start-Up Operation in Continuous Wet Granulation"
   Processes, 9, 1502 (2021)
3. Junu Kim, Kensaku Matsunami, Kozue Okamura, Sara Badr, Hirokazu Sugiyama
   "Determination of critical decision points for COVID-19 measures in Japan"
   Scientific Reports, 11, 16416 (2021)
4. 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"
   Computers & Chemical Engineering, 153, 107422 (2021)
5. 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, 16, 213–225 (2021)
6. Yusuke Hayashi, Yuka Nakajima, Hirokazu Sugiyama
   "Computational screening of cryoprotective agents for regenerative medical products using quantum chemistry and molecular dynamics simulations"
   Cryobiology, 100, 101–109 (2021)
7. 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, 54, 152–161 (2021)
8. 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)
9. 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)
10. 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)

2020

1. 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)
2. 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)
3. 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)
4. 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) [open access, invited article]
5. 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)
6. Kensaku Matsunami, Takuya Nagato, Koji Hasegawa, Hirokazu Sugiyama
   "Determining key parameters of continuous wet granulation for tablet quality and productivity: A case in ethenzamide"
   International Journal of Pharmaceutics, 579, 119160 (2020)
7. 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) [open access, invited article]
8. 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)

2019

1. 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)
2. 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)
3. 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) [open access, invited article]
4. 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)
5. 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) [invited article]
6. 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) [open access]
7. 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, 122, 114–128 (2019) [invited article]
8. 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)

2018

1. 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) [open access, invited article]
2. 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)
3. 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)

2017

1. 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)
2. 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)
3. 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)

2016

1. 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)
2. Lukas Gallus Eberle, Elisabet Capón-Carcía, Hirokazu Sugiyama, Andreas Graser, Rainer Schmidt, Konrad Hungerbühler
   "Rigorous approach to scheduling of sterile drug product manufacturing"
   Computers & Chemical Engineering, 94, 221–234 (2016)
3. 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)

2015

1. 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(4), 287–301 (2015)
2. 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(4), 313–323 (2015)
3. 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)
4. Hirokazu Sugiyama, Masaaki Ito, Masahiko Hirao
   "Planning Method for Reducing Product Losses in Manufacturing Sterile Drug Products"
   Journal of Chemical Engineering of Japan, 48(10), 848–855 (2015)