


Sugiyama-Badr Laboratory
2023
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)
DOI: 10.1039/D3RE00215B
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)
DOI: 10.1080/00219592.2023.2201310
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)
DOI: 10.1016/j.compchemeng.2023.108157
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)
DOI: 10.1016/j.compchemeng.2023.108144
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)
DOI: 10.1016/j.cherd.2023.01.021
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)
DOI: 10.1016/j.compchemeng.2023.108141
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)
DOI: 10.1016/j.cherd.2022.11.012
2022
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)
DOI: 10.1021/acs.iecr.2c00736
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)
DOI: 10.1021/acsomega.2c04182
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)
DOI: 10.1016/j.cherd.2022.09.005
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)
DOI: 10.1016/j.biotechadv.2022.108015
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)
DOI: 10.1016/j.compchemeng.2022.107851
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)
DOI: 10.1021/acs.iecr.2c00374
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)
DOI: 10.1016/j.cherd.2022.03.038
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)
DOI: 10.1016/j.ijpharm.2021.121353
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)
DOI: 10.1016/j.compchemeng.2021.107566
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)
DOI: 10.1016/j.compchemeng.2021.107541
2021
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)
DOI: 10.1021/acssuschemeng.1c01435
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)
DOI: 10.3390/pr9091502
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)
DOI: 10.1038/s41598-021-95617-z
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)
DOI: 10.1016/j.compchemeng.2021.107422
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)
DOI: 10.1007/s12247-020-09434-4
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)
DOI: 10.1016/j.cryobiol.2021.03.002
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)
DOI: 10.1252/jcej.20we090
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
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
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
2020
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
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
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
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]
DOI: 10.1016/j.coche.2020.01.003
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
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)
DOI: 10.1016/j.ijpharm.2020.119160
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]
DOI: 10.1186/s42480-020-0028-2
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
2019
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
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
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, 448 (2019) [open access, invited article]
DOI: 10.3390/pr7070448
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
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]
DOI: 10.1016/j.compchemeng.2018.12.019
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]
DOI: 10.1016/j.ijpharm.2019.01.028
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]
DOI: 10.1016/j.compchemeng.2018.06.001
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
2018
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]
DOI: 10.1021/acs.iecr.7b05230
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
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
2017
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
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
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
2016
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
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)
DOI: 10.1016/j.compchemeng.2016.07.028
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
2015
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)
DOI: 10.1007/s12247-015-9226-5
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)
DOI: 10.1007/s12247-015-9228-3
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)
DOI: 10.1016/j.compchemeng.2015.05.024
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)
DOI: 10.1252/jcej.14we422