Sugiyama-Badr Laboratory

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
DOI: 10.1016/j.compchemeng.2024.108822

Kosuke Nemoto, Yusuke Hayashi, Hirokazu Sugiyama
“Indicator-based assessment of potential supply risks for pharmaceutical excipients: Method and application”
International Journal of Pharmaceutics, Accepted
DOI: 10.1016/j.ijpharm.2024.124498

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
DOI: 10.1016/j.cherd.2024.07.037

Kozue Okamura, Sara Badr, Yusuke Ichida, Akira Yamada, Hirokazu Sugiyama
“Modeling of cell cultivation for monoclonal antibody production processes considering lactate metabolic shifts”
Kozue Okamura, Sara Badr, Yusuke Ichida, Akira Yamada, Hirokazu Sugiyama, Accepted
DOI: https://doi.org/10.1021/acs.oprd.3c00380

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)
DOI: https://doi.org/10.1016/j.cherd.2024.04.013

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)
DOI: https://doi.org/10.1016/j.coche.2024.101019

K. Hirono, Y. Hayashi, I.A. Udugama, Y. Takemoto, R. Kato, M. Kino-oka, H. Sugiyama
“Image-based hybrid model incorporating initial spatial distribution for mesenchymal stem cell cultivation process design”
AIChE Journal, Accepted
DOI: https://doi.org/10.1002/aic.18452

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)
DOI: 10.1021/acs.oprd.3c00380

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)
DOI: https://doi.org/10.1016/j.cryobiol.2024.104885

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)
DOI: https://doi.org/10.1080/00219592.2024.2313318

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)
DOI: https://doi.org/10.1007/s12247-023-09788-5

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)
DOI: https://doi.org/10.1021/acs.iecr.3c02137

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) DOI: 10.1016/j.cherd.2023.10.009

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

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, 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, 108144 (2023) DOI: 10.1016/j.compchemeng.2023.108144

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, 108141 (2023) DOI: 10.1016/j.compchemeng.2023.108141

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

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

Daniel R. Lewin, Emilia M. Kondili, Ian T. Cameron, Grégoire Léonard, Seyed Soheil Mansouri, Fernando G. Martins, Luis Ricardez-Sandoval, Hirokazu Sugiyama, Edwin Zondervan
"Agile process systems engineering education: What to teach, and how to teach"
Computers & Chemical Engineering, 170, 108134 (2023) DOI: 10.1016/j.compchemeng.2023.108134

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

Kozue Okamura, Sara Badr, Sei Murakami, and 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) 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

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

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

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

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

Hiroaki Arai, Takuya Nagato, Tatsuo Koide, Etsuo Yonemochi, Hiromitsu Yamamoto, Hirokazu Sugiyama
"Tablet quality-prediction model using quality material attributes: toward flexible switching between batch and continuous granulation"
Journal of Pharmaceutical Innovation, 16, 588–602 (2021) DOI: 10.1007/s12247-020-09466-w

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

Keita Yaginuma, Shuichi Tanabe, Hirokazu Sugiyama, Manabu Kano
"Prediction performance and economic efficiency of soft sensors for in-line water content monitoring in fluidized bed granulation: PP-based model vs. NIRS-based model"
Chemical and Pharmaceutical Bulletin, 69, 548–556 (2021), DOI: 10.1248/cpb.c20-01016

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

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

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

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

Hayato Ishimoto, Manabu Kano, Hirokazu Sugiyama, Hirofumi Takeuchi, Katsuhide Terada, Atsushi Aoyama, Takuji Shoda, Yosuke Demizu, Jinen Shimamura, Reiji Yokoyama, Yuji Miyamoto, Koji Hasegawa, Masaru Serizawa, Kazuomi Unosawa, Kazuo Osaki, Naochika Asai, Yoshihiro Matsuda
"Approach to establishment of control strategy for oral solid dosage forms using continuous manufacturing"
Chemical and Pharmaceutical Bulletin, 69, 211–217 (2021), DOI: 10.1248/cpb.c20-00824

Yasuhiro Suzuki, Hirokazu Sugiyama, Manabu Kano, Ryutaro Shimono, Gosuke Shimada, Ryoichi Furukawa, Eichi Mano, Keiichi Motoyama, Tatsuo Koide, Yasuhiro Matsui, Kazuki Kurasaki, Issei Takayama, Shunin Hikage, Noriko Katori, Masahiko Kikuchi, Hiroshi Sakai, Yoshihiro Matsuda
"Control strategy and methods for continuous direct compression processes"
Asian Journal of Pharmaceutical Sciences, 16, 253–262, DOI: 10.1016/j.ajps.2020.11.005

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

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

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

Eri Amasawa, Mikiaki Hasegawa, Naoki Yokokawa, Hirokazu Sugiyama, Masahiko Hirao
"Environmental performance of an electric vehicle composed of 47% polymers and polymer composites"
Sustainable Materials and Technologies, 25, e00189 (2020), DOI: 10.1016/j.susmat.2020.e00189

Naoki Yokokawa, Yutaro Masuda, Eri Amasawa, Hirokazu Sugiyama, Masahiko Hirao
"Systematic packaging design tools integrating functional and environmental consequences on product life cycle: Case studies on laundry detergent and milk"
Packaging Technology and Science, 33, 445–459 (2020), DOI: 10.1002/pts.2526

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

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), DOI: 10.1186/s42480-020-0028-2

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

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

Eri Amasawa, Tsubasa Shibata, Hirokazu Sugiyama, Masahiko Hirao
"Environmental potential of reusing, renting, and sharing consumer products: systematic analysis approach"
Journal of Cleaner Production, 242, 118487 (2020), DOI: 10.1016/j.jclepro.2019.118487

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

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

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

Naoki Yokokawa, Emi Kikuchi-Uehara, Eri Amasawa, Hirokazu Sugiyama, Masahiko Hirao
"Environmental analysis of packaging-derived changes in food production and consumer behavior"
Journal of Industrial Ecology, 23(5), 1253–1263 (2019), DOI: 10.1111/jiec.12918

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

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), DOI: 10.1016/j.compchemeng.2018.12.019

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

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

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

Eri Amasawa, Yurie Suzuki, Dami Moon, Jun Nakatani, Hirokazu Sugiyama, Masahiko Hirao
"Designing interventions for behavioral shifts toward product sharing: The case of laundry activities in Japan"
Sustainability, 10(8), 2687 (2018), DOI: 10.3390/su10082687

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, 1272–1284 (2018), DOI: 10.1002/aic.16020

Naoki Yokokawa, Emi Kikuchi-Uehara, Hirokazu Sugiyama, Masahiko Hirao "Framework for analyzing the effects of packaging on food loss reduction by considering consumer behavior" Journal of Cleaner Production, 174, 26–34 (2018), DOI: 10.1016/j.jclepro.2017.10.242

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 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

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, 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

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

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

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, 848–855 (2015), DOI: 10.1252/jcej.14we422

Teruyuki Shimizu, Yasunori Kikuchi, Hirokazu Sugiyama, Masahiko Hirao "Design method for a local energy cooperative network using distributed energy technologies" Applied Energy, 154, 781–793 (2015), DOI: 10.1016/j.apenergy.2015.05.032

I-Ching Chen, Yasunori Kikuchi, Yasuhiro Fukushima, Hirokazu Sugiyama, Masahiko Hirao "Developing technology introduction strategies based on visualized scenario analysis: application in energy systems design" Environmental Progress & Sustainable Energy, 34, 832–840 (2015), DOI: 10.1002/ep.12064

Lukas Gallus Eberle, Hirokazu Sugiyama, Rainer Schmidt "Improving lead time of pharmaceutical production processes using Monte Carlo simulation" Computers & Chemical Engineering, 68, 255–263 (2014), DOI: 10.1016/j.compchemeng.2014.05.017

Georg Müller, Hirokazu Sugiyama, Simon Stocker, Rainer Schmidt "Reducing energy consumption in pharmaceutical production: framework and case study" Journal of Pharmaceutical Innovation, 9, 212–226 (2014), DOI: 10.1007/s12247-014-9188-z

杉山 弘和, シュミット ライナー "医薬品製造における継続的改善のビジネスプロセスモデル" 化学工学論文集, 40, 201–210 (2014), DOI: 10.1252/kakoronbunshu.40.201

Yasunori Kikuchi, Masahiko Hirao, Hirokazu Sugiyama, Stavros Papadokonstantakis, Konrad Hungerbühler, Takashi Ookubo, Akinobu Sasaki "Design of recycling system for poly (methyl methacrylate) (PMMA). Part 2: process hazards and material flow analysis"International Journal of Life Cycle Assessment, 19, 307–319 (2014), DOI: 10.1007/s11367-013-0625-x

Alireza Banimostafa, Thuy Thi Hong Nguyen, Yasunori Kikuchi, Stavros Papadokonstantakis, Hirokazu Sugiyama, Masahiko Hirao, Konrad Hungerbühler "Safety, health and environmental assessment of bioethanol production from sugarcane, corn and corn stover" Green Processing and Synthesis, 1, 449–461 (2012), DOI: 10.1515/gps-2012-0042

Hirokazu Sugiyama, Lars Sukowski, Rainer Schmidt ""Japan Quality" in pharmaceutical technical operations. Part II: Building a blueprint for better performance in the Japanese market" Pharmazeutische Industrie, 73, 912–918 (2011)

Hirokazu Sugiyama, Lars Sukowski, Rainer Schmidt ""Japan Quality" in pharmaceutical technical operations. Part I: Understanding differences in quality expectations between Western and Japanese markets" Pharmazeutische Industrie, 73, 754–759 (2011)

Thuy Thi Hong Nguyen, Yasunori Kikuchi, Hirokazu Sugiyama, Masaru Noda, Masahiko Hirao "Techno-economic and environmental assessment of bioethanol based chemical process: A case on ethyl acetate" Environmental Progress & Sustainable Energy, 30, 675–684 (2011), DOI: 10.1002/ep.10517

Thomas Albrecht, Stavros Papadokonstantakis, Hirokazu Sugiyama, Konrad Hungerbühler "Demonstrating multi-objective screening of chemical batch process alternatives during early design phases" Process Safety and Environmental Protection, 88, 529–550 (2010), DOI: 10.1016/j.cherd.2009.11.009

Thuy Thi Hong Nguyen, Hirokazu Sugiyama, Masaru Noda, Masahiko Hirao, "Structural framework supporting selection of extraction processes under sustainable criteria" Journal of Chemical Engineering of Japan, 43, 186–195 (2010), DOI: 10.1252/jcej.09we121

Andrea Anja Bumann, Stavros Papadokonstantakis, Hirokazu Sugiyama, Ulrich Fischer, Konrad Hungerbühler "Evaluation and analysis of a proxy indicator for the estimation of gate-to-gate energy consumption in the early process design phases: The case of organic solvent production" Energy, 35, 2407–2418 (2010), DOI: 10.1016/j.energy.2010.02.023

Hirokazu Sugiyama, Ulrich Fischer, Elena Antonijuan, Volker H. Hoffmann, Masahiko Hirao, Konrad Hungerbühler "How do different process options and evaluation settings affect economic and environmental assessments? A case study on methyl methacrylate (MMA) production processes" Process Safety and Environmental Protection, 87, 361–370 (2009), DOI: 10.1016/j.psep.2009.08.002

Hirokazu Sugiyama, Masahiko Hirao, Ulrich Fischer, Konrad Hungerbühler "Activity modeling for integrating Environmental, Health and Safety (EHS) consideration as a new element in industrial chemical process design" Journal of Chemical Engineering of Japan, 41, 884–897 (2008, Outstanding paper award), DOI: 10.1252/jcej.07we263

Hirokazu Sugiyama, Ulrich Fischer, Masahiko Hirao, Konrad Hungerbühler "Decision-making framework for chemical process design including different stages of Environmental, Health and Safety (EHS) assessment" AIChE Journal, 54, 1037–1053 (2008), DOI: 10.1002/aic.11430

Isaac Kweku Adu, Hirokazu Sugiyama, Ulrich Fischer, Konrad Hungerbühler "Comparison of methods for assessing Environmental, Health and Safety (EHS) hazards in early phases of chemical process design" Process Safety and Environmental Protection, 86, 77–93 (2008), DOI: 10.1016/j.psep.2007.10.005

Hirokazu Sugiyama, Masahiko Hirao, Ramon Mendivil, Ulrich Fischer, Konrad Hungerbühler "A hierarchical methodology for chemical process design based on Life Cycle Assessment" Process Safety and Environmental Protection, 84, 63–74 (2006, Top 75 most cited award, 2006-2009), DOI: 10.1205/psep.04142

Hirokazu Sugiyama, Yasuhiro Fukushima, Masahiko Hirao, Stefanie Hellweg, Konrad Hungerbühler "Using standard statistics to consider uncertainty in industry-based Life Cycle Inventory databases" International Journal of Life Cycle Assessment, 10, 399–405 (2005), DOI: 10.1065/lca2005.05.211

平尾 雅彦, 杉山 弘和 "環境影響を考慮した化学プロセス設計のための統合情報基盤" 日本コンピュータ化学会論文誌, 2, 79–86 (2003), DOI: 10.2477/jccj.2.79

Yusuke Hayashi, Benedikt X. Scholz, Hirokazu Sugiyama "A CFD-model-based approach to continuous freezing process design for human induced pluripotent stem cells" 33rd European Symposium on Computer Aided Process Engineering, Elsevier, Computer Aided Chemical Engineering, 52, 65–70 (2023)

Sara Badr, Kota Oishi, Kozue Okamura, Sei Murakami, Hirokazu Sugiyama "Hybrid modelling and data-driven parameterization of monoclonal antibody cultivation processes: Shifts in cell metabolic behavior" Elsevier, Computer Aided Chemical Engineering, 52, 985–990 (2023)

Daniel R. Lewin, Ian T. Cameron, Emilia M. Kondili, Grégoire Léonard, Seyed Sohei Mansouri, Fernando G. Martins, Luis Ricardez-Sandoval, Hirokazu Sugiyama, Edwin Zondervan "Agile Process Systems Engineering (PSE) education – 2. How to teach to achieve desired outcomes mastery by graduates" 32nd European Symposium on Computer Aided Process Engineering, Elsevier, Computer Aided Chemical Engineering, 51, 1675–1680 (2022), DOI: 10.1016/B978-0-323-95879-0.50280-0

Emilia M. Kondili, Ian T. Cameron, Grégoire Léonard, Daniel R. Lewin, Seyed Soheil Mansouri, Fernando G. Martins, Luis Ricardez-Sandoval, Hirokazu Sugiyama, Edwin Zondervan "Agile Process Systems Engineering (PSE) education – 1. What should be taught to achieve desired outcomes mastery by graduates?" 32nd European Symposium on Computer Aided Process Engineering, Elsevier, Computer Aided Chemical Engineering, 51, 1663–1668 (2022), DOI: 10.1016/B978-0-323-95879-0.50278-2

Rafiqul Gani, Xi Chen, Mario R. Eden, Seyed S. Mansouri, Mariano Martin, Iqbal M. Mujtaba, Orakotch Padungwatanaroj, Kosan Roh, Luis Ricardez-Sandoval, Hirokazu Sugiyama, Jinsong Zhao, Edwin Zondervan "Challenges and Opportunities for Process Systems Engineering in a Changed World" 14th International Symposium on Process System Engineering, Elsevier, Computer Aided Chemical Engineering, 49, 7–20 (2022), DOI: 10.1016/B978-0-323-85159-6.50002-6

Yusuke Hayashi, Kota Oishi, Hirokazu Sugiyama "An agent-based model for cost-effectiveness analysis in the manufacture of allogeneic human induced pluripotent cells in Japan" 14th International Symposium on Process System Engineering, Elsevier, Computer Aided Chemical Engineering, 49, 2203–2208 (2022) DOI: 10.1016/B978-0-323-85159-6.50367-5

Masahiro Yamada, Isuru A. Udugama, Sara Badr, Kenichi Zenitani, Kokichi Kubota, Hayao Nakanishi, Hirokazu Sugiyama "Pharma PSE: a multiscale approach for reimagining pharmaceutical manufacturing" 14th International Symposium on Process System Engineering, Elsevier, Computer Aided Chemical Engineering, 49, 2191–2196 (2022) DOI: 10.1016/B978-0-323-85159-6.50365-1

Kozue Okamura, Sara Badr, Sei Murakami, Hirokazu Sugiyama "Hybrid modelling of CHO-MK cell cultivation in monoclonal antibody production" 14th International Symposium on Process System Engineering, Elsevier, Computer Aided Chemical Engineering, 49, 2137–2142 (2022) DOI: 10.1016/B978-0-323-85159-6.50356-0

Philipp Samuel Zuercher, Sara Badr, Stephanie Knueppel, Hirokazu Sugiyama "Data-driven operation support for equipment deterioration detection in drug product manufacturing" 14th International Symposium on Process System Engineering, Elsevier, Computer Aided Chemical Engineering, 49, 1519–1524 (2022) DOI: 10.1016/B978-0-323-85159-6.50253-0

Junu Kim, Hironori Yonekura, Takeaki Watanabe, Satoshi Yoshikawa, Hayao Nakanishi, Hirokazu Sugiyama, Sara Badr "Rigorous modeling for assessing batch and flow syntheses of drug substance in heterogeneous hydrogenation" 14th International Symposium on Process System Engineering, Elsevier, Computer Aided Chemical Engineering, 49, 877–882 (2022) DOI: 10.1016/B978-0-323-85159-6.50146-9

Sara Badr, Kozue Okamura, Nozomi Takahashi, Hirokazu Sugiyama "Techno-economic assessment of upstream and downstream process alternatives for the production of monoclonal antibodies" 14th International Symposium on Process System Engineering, Elsevier, Computer Aided Chemical Engineering, 49, 745–750 (2022) DOI: 10.1016/B978-0-323-85159-6.50124-X

Kensaku Matsunami, Sara Badr, Hirokazu Sugiyama "Framework for designing solid drug product manufacturing processes based on economic and quality assessment" 14th International Symposium on Process System Engineering, Elsevier, Computer Aided Chemical Engineering, 49, 223–228 (2022) DOI: 10.1016/B978-0-323-85159-6.50037-3

Hirokazu Sugiyama "Pharma PSE: a multiscale approach for reimagining pharmaceutical manufacturing" 14th International Symposium on Process System Engineering, Elsevier, Computer Aided Chemical Engineering, 49, 59–64 (2022) DOI: 10.1016/B978-0-323-85159-6.50009-9

Keita Hirono, Isuru A. Udugama, Yusuke Hayashi, Masahiro Kino-oka, Hirokazu Sugiyama "Design space determination of mesenchymal stem cell cultivation by dynamic modeling under uncertainty" 32nd European Symposium on Computer Aided Process Engineering, Elsevier, Computer Aided Chemical Engineering, 51, 721–726 (2022) DOI: 10.1016/B978-0-323-95879-0.50121-1

Yusuke Hayashi, Ikki Horiguchi, Masahiro Kino-oka, Hirokazu Sugiyama "Model-based design of freezing temperature profile for human induced pluripotent stem cells" Cryobiology, 97, 274 (2020) DOI: 10.1016/j.cryobiol.2020.10.099

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" Sauro Pierucci, Flavio Manenti, Giulia Luisa Bozzano & Davide Manca (Eds.): 30th European Symposium on Computer Aided Process Engineering, Elsevier, Computer Aided Chemical Engineering, 48, 1609–1614 (2020) DOI: 10.1016/B978-0-12-823377-1.50269-X

Keisho Yabuta, Haruka Futamura, Koji Kawasaki, Hirokazu Sugiyama "Integrated design of process configuration and scheduling for hydrogen peroxide decontamination in biopharmaceutical injectable manufacturing" Sauro Pierucci, Flavio Manenti, Giulia Luisa Bozzano & Davide Manca (Eds.): 30th European Symposium on Computer Aided Process Engineering, Elsevier, Computer Aided Chemical Engineering, 48, 853–858 (2020) DOI: 10.1016/B978-0-12-823377-1.50143-9

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" Sauro Pierucci, Flavio Manenti, Giulia Luisa Bozzano & Davide Manca (Eds.): 30th European Symposium on Computer Aided Process Engineering, Elsevier, Computer Aided Chemical Engineering, 48, 265–270 (2020) DOI: 10.1016/B978-0-12-823377-1.50045-8

Samir Diab, Sara Badr, Hirokazu Sugiyama, Dimitrios I. Gerogiorgis "Dynamic simulation and visualisation of ph-modulated fed-batch fermentation for mab production from CHO cell cultures" Sauro Pierucci, Flavio Manenti, Giulia Luisa Bozzano & Davide Manca (Eds.): 30th European Symposium on Computer Aided Process Engineering, Elsevier, Computer Aided Chemical Engineering, 48, 1657–1662 (2020) DOI: 10.1016/B978-0-12-823377-1.50277-9

Yusuke Hayashi, Ikki Horiguchi, Masahiro Kino-oka, Hirokazu Sugiyama "Integrated white-box models for designing freezing processes of human induced pluripotent stem cells considering diversity within a container" In. Anton A. Kiss, Edwin Zondervan, Richard Lakerveld & Leyla Özkan (Eds.): 29th European Symposium on Computer Aided Process Engineering, Elsevier, Computer Aided Chemical Engineering, 46, 877–882 (2019) DOI: 10.1016/B978-0-12-818634-3.50147-8

Haruku Shirahata, Samir Diab, Hirokazu Sugiyama, Dimitrios I. Gerogiorgis "Dynamic modelling and simulation of Chinese hamster ovary (CHO) cell fermentation for advanced biopharmaceutical manufacturing" In. Anton A. Kiss, Edwin Zondervan, Richard Lakerveld & Leyla Özkan (Eds.): 29th European Symposium on Computer Aided Process Engineering, Elsevier, Computer Aided Chemical Engineering, 46, 673–678 (2019) DOI: 10.1016/B978-0-12-818634-3.50113-2

Gioele Casola, Christian Siegmund, Markus Mattern, Hirokazu Sugiyama "Data Mining-based algorithm for pre-processing biopharmaceutical manufacturing records" In. Mario R. Eden, Marianthi Ierapetritou & Gavin P. Towler (Eds.): the 13th International Symposium on Process Systems Engineering – PSE 2018, Elsevier, Computer Aided Chemical Engineering, 44, 2263–2268 (2018) DOI: 10.1016/B978-0-444-64241-7.50372-4

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" In. Mario R. Eden, Marianthi Ierapetritou & Gavin P. Towler (Eds.): the 13th International Symposium on Process Systems Engineering – PSE 2018, Elsevier, Computer Aided Chemical Engineering, 44, 2131–2136 (2018) DOI: 10.1016/B978-0-444-64241-7.50350-5

Haruku Shirahata, Shant Dakessian, Masahiko Hirao, Hirokazu Sugiyama "Multilayer and multiobjective design platform for drug product manufacturing processes of biopharmaceuticals" In. Mario R. Eden, Marianthi Ierapetritou & Gavin P. Towler (Eds.): the 13th International Symposium on Process Systems Engineering – PSE 2018, Elsevier, Computer Aided Chemical Engineering, 44, 301–306 (2018) DOI: 10.1016/B978-0-444-64241-7.50045-8

Hirokazu Sugiyama, Yusuke Morikawa, Mai Matsuura, Menghe Xu "Quantitative analysis on the relevance of regulatory constraints in designing pharmaceutical manufacturing processes" In. Mario R. Eden, Marianthi Ierapetritou & Gavin P. Towler (Eds.): the 13th International Symposium on Process Systems Engineering – PSE 2018, Elsevier, Computer Aided Chemical Engineering, 44, 2119–2124 (2018) DOI: 10.1016/B978-0-444-64241-7.50348-7

Naoki Yokokawa, Yutaro Masuda, Eri Amasawa, Hirokazu Sugiyama, Masahiko Hirao "Network visualization of design variables and functions for sustainable packaging designs" In. Mario R. Eden, Marianthi Ierapetritou & Gavin P. Towler (Eds.): the 13th International Symposium on Process Systems Engineering – PSE 2018, Elsevier, Computer Aided Chemical Engineering, 44, 1771–1776 (2018) DOI: 10.1016/B978-0-444-64241-7.50290-1

Keisho Yabuta, Haruka Futamura, Koji Kawasaki, Masahiko Hirao, Hirokazu Sugiyama "Models for designing hydrogen peroxide decontamination processes in sterile drug product manufacturing" In. Anton Friedl, Jiří J. Klemeš, Stefan Radl, Petar S. Varbanov & Thomas Wallek (Eds.): 28th European Symposium on Computer Aided Process Engineering, Elsevier, Computer Aided Chemical Engineering, 43, 1613–1618 (2018) DOI: 10.1016/B978-0-444-64235-6.50281-3

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" In. Anton Friedl, Jiří J. Klemeš, Stefan Radl, Petar S. Varbanov & Thomas Wallek (Eds.): 28th European Symposium on Computer Aided Process Engineering, Elsevier, Computer Aided Chemical Engineering, 43, 1655–1660 (2018) DOI: 10.1016/B978-0-444-64235-6.50288-6

Haruku Shirahata, Masahiko Hirao, Hirokazu Sugiyama "Risk Evaluation Models for the Design of Parenterals Manufacturing Processes" In. Antonio Espuña, Moisès Graells & Luis Puigjaner (Eds.): 27th European Symposium on Computer Aided Process Engineering, Elsevier, Computer Aided Chemical Engineering, 40, 2791–2796 (2017) DOI: 10.1016/B978-0-444-63965-3.50467-0

Hirokazu Sugiyama, Kensaku Matsunami, Keisho Yabuta "Process Systems Engineering Approaches for Drug Product Manufacturing: from Tablets to Injectables" In. Antonio Espuña, Moisès Graells & Luis Puigjaner (Eds.): 27th European Symposium on Computer Aided Process Engineering, Elsevier, Computer Aided Chemical Engineering, 40, 2785–2790 (2017) DOI: 10.1016/B978-0-444-63965-3.50466-9

Gioele Casola, Christian Siegmund, Markus Mattern, Hirokazu Sugiyama "Integrated Process Performance Assessment Considering Uncertainty in Biopharmaceutical Manufacturing Operations" In. Antonio Espuña, Moisès Graells & Luis Puigjaner (Eds.): 27th European Symposium on Computer Aided Process Engineering, Elsevier, Computer Aided Chemical Engineering, 40, 2227–2232 (2017) DOI: 10.1016/B978-0-444-63965-3.50373-1

Gioele Casola, Lukas Gallus Eberle, Christian Siegmund, Markus Mattern, Hirokazu Sugiyama "Mid-term scheduling model based on state-task-network considering plant specific constraints in pharmaceutical manufacturing" In. Zdravko Kravanja & Miloš Bogataj (Eds.): 26th European Symposium on Computer Aided Process Engineering, Elsevier, Computer Aided Chemical Engineering, 38, 1141–1146 (2016) DOI: 10.1016/B978-0-444-63428-3.50195-8

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 environmental, health and safety risks" In. Zdravko Kravanja & Miloš Bogataj (Eds.): 26th European Symposium on Computer Aided Process Engineering, Elsevier, Computer Aided Chemical Engineering, 38, 79–84 (2016) DOI: 10.1016/B978-0-444-63428-3.50018-7

Hirokazu Sugiyama, Masaaki Ito, Masahiko Hirao "Process-based method for reducing product losses in pharmaceutical manufacturing" In. K. V. Gernaey, J. K. Huusom & R. Gani (Eds.): 12th International Symposium on Process Systems Engineering and 25th European Symposium on Computer Aided Process Engineering, Elsevier, Computer Aided Chemical Engineering, 36, pp. 2189–2194 (2015) DOI: 10.1016/B978-0-444-63576-1.50056-X

Gioele Casola, Hirokazu Sugiyama, Satoshi Yoshikawa, Hayao Nakanishi, Masahiko Hirao "Systematic retrofitting methodology for recrystallization of thermally unstable active pharmaceutical ingredients" In. K. V. Gernaey, J. K. Huusom & R. Gani (Eds.): 12th International Symposium on Process Systems Engineering and 25th European Symposium on Computer Aided Process Engineering, Elsevier, Computer Aided Chemical Engineering, 36, pp. 2171–2176 (2015) DOI: 10.1016/B978-0-444-63576-1.50059-5

Lukas Gallus Eberle, Hirokazu Sugiyama, Stavros Papadokonstantakis, Andreas Graser, Rainer Schmidt, Konrad Hungerbühler, "Improving pharmaceutical batch production processes with data-based tiered approach" In. K. V. Gernaey, J. K. Huusom & R. Gani (Eds.): 12th International Symposium on Process Systems Engineering and 25th European Symposium on Computer Aided Process Engineering, Elsevier, Computer Aided Chemical Engineering, 36, pp. 1967–1972 (2015) DOI: 10.1016/B978-0-444-63576-1.50022-4

Lukas Gallus Eberle, Elisabet Capón-Garcia, Martin Senninger, Hirokazu Sugiyama, Andreas Graser, Rainer Schmidt, Konrad Hungerbühler "Optimal scheduling of liquid drug product manufacturing" In. K. V. Gernaey, J. K. Huusom & R. Gani (Eds.): 12th International Symposium on Process Systems Engineering and 25th European Symposium on Computer Aided Process Engineering, Elsevier, Computer Aided Chemical Engineering, 36, 2033–2038 (2015) DOI: 10.1016/B978-0-444-63576-1.50033-9

Hirokazu Sugiyama, Masahiko Hirao "Integration framework for improving quality and cost-effectiveness in pharmaceutical production processes" In. J. J. Klemeš, P. S. Varbanov & P. Y. Liew (Eds.): Proceedings of the 24th European Symposium on Computer Aided Process Engineering, Elsevier, Computer Aided Chemical Engineering, 33, pp. 379–384 (2014) DOI: 10.1016/B978-0-444-63456-6.50064-8

Lukas Gallus Eberle, Hirokazu Sugiyama, Stavros Papadokonstantakis, Andreas Graser, Rainer Schmidt, Konrad Hungerbühler "Data-based approach for efficient yield enhancement in pharma production" In. J. J. Klemeš, P. S. Varbanov & P. Y. Liew (Eds.): Proceedings of the 24th European Symposium on Computer Aided Process Engineering, Elsevier, Computer Aided Chemical Engineering, 33, pp. 463–468 (2014) DOI: 10.1016/B978-0-444-63456-6.50078-8

Baharuddin Maghfuri, Hirokazu Sugiyama, Yasunori Kikuchi, Masahiko Hirao "Design methodology of biomass utilization system considering impacts on petroleum refining industry" In. J. J. Klemeš, P. S. Varbanov & P. Y. Liew (Eds.): Proceedings of the 24th European Symposium on Computer Aided Process Engineering, Elsevier, Computer Aided Chemical Engineering, 33, pp. 1003–1008 (2014) DOI: 10.1016/B978-0-444-63455-9.50002-7

Hirokazu Sugiyama, Rainer Schmidt "Business model of continuous improvement in pharmaceutical production processes" In. A. Kraslawski & I. Turunen (Eds.): Proceedings of the 23rd European Symposium on Computer Aided Process Engineering, Elsevier, Computer Aided Chemical Engineering, 32, pp. 697-702 (2013) DOI: 10.1016/B978-0-444-63234-0.50117-2

Lukas Gallus Eberle, Hirokazu Sugiyama, Rainer Schmidt "Improving lead time of sterile drug product manufacturing using Monte Carlo simulation" In. A. Kraslawski & I. Turunen (Eds.): Proceedings of the 23rd European Symposium on Computer Aided Process Engineering, Elsevier, Computer Aided Chemical Engineering, 32, pp. 685–690 (2013) DOI: 10.1016/B978-0-444-63234-0.50115-9

Hirokazu Sugiyama, Rainer Schmidt "Model-based optimization in pharmaceutical technical operations – yield measurement and increase in Roche’s Parenterals production Kaiseraugst" In. I. D. L. Bogle & M. Fairweather (Eds): 22nd European Symposium on Computer Aided Process Engineering, Elsevier, Computer Aided Chemical Engineering, 31, pp. 577–581 (2012) DOI: 10.1016/B978-0-444-59519-5.50116-7

Hirokazu Sugiyama, Rainer Schmidt "Realizing continuous improvement in pharmaceutical technical operations – business process model in Roche’s Parenterals production Kaiseraugst" In. I. D. L. Bogle & M. Fairweather (Eds): 22nd European Symposium on Computer Aided Process Engineering, Elsevier, Computer Aided Chemical Engineering, 31, pp. 422–426 (2012) DOI:10.1016/B978-0-444-59519-5.50085-X

Yasunori Kikuchi, Stavros Papadokonstantakis, Alireza Banimostafa, Hirokazu Sugiyama, Konrad Hungerbühler, Masahiko Hirao "Analysis and modeling of information required for process assessment on environment, health, and safety by IDEF0 and UML" In. I.A. Karimi & R. Srinivasan (Eds): 11th International Symposium on Process Systems Engineering, Computer Aided Chemical Engineering, 31, 1392–1396 (2012) DOI: 10.1016/B978-0-444-59506-5.50109-7

Thuy Thi Hong Nguyen, Yasunori Kikuchi, Masaru Noda, Hirokazu Sugiyama, Masahiko Hirao "Design and assessment of bio-ethanol based chemical process for sustainability" In. S. Pierucci & G. B. Ferraris (Eds): 20th European Symposium on Computer Aided Process Engineering, Elsevier, Aided Chemical Engineering, 28, pp. 1955–1960 (2010)

Stavros Papadokonstantakis, Agarwal Siddharta, Hirokazu Sugiyama, Konrad Hungerbühler "Uncertainty patterns and sensitivity analysis of an indicator based process design framework" In. B. Braunschweig & X. Joulia (Eds.): 18th European Symposium on Computer Aided Process Engineering, Elsevier, Computer Aided Chemical Engineering, 25, pp. 145–150 (2008) DOI: 10.1016/S1570-7946(08)80029-6

Masahiko Hirao, Hirokazu Sugiyama, Ulrich Fischer, Konrad Hungerbühler "IDEF0 activity modeling for integrated process design considering Environmental, Health and Safety (EHS) aspects" In. B. Braunschweig & X. Joulia (Eds.): 18th European Symposium on Computer Aided Process Engineering, Elsevier, Computer Aided Chemical Engineering, 25, pp. 1065–1070 (2008) DOI: 10.1016/S1570-7946(08)80184-8

Hirokazu Sugiyama, Ulrich Fischer, Masahiko Hirao, Konrad Hungerbühler "A chemical process design framework including different stages of Environmental, Health and Safety (EHS) assessment" In. V. Plesu & P.S. Agachi (Eds.): 17th European Symposium on Computer Aided Process Engineering, Elsevier, Computer Aided Chemical Engineering, 24, pp. 1157–1162 (2007) DOI: 10.1016/S1570-7946(07)80217-3

Hirokazu Sugiyama, Ulrich Fischer, Masahiko Hirao, Konrad Hungerbühler "A chemical process design framework including different stages of Environmental, Health and Safety (EHS) assessment" In. W. Marquardt & C. Pantelides (Eds.): 16th European Symposium on Computer Aided Process Engineering and 9th international symposium on Process Systems Engineering, Elsevier, Computer Aided Chemical Engineering, 21, pp. 1021–1026 (2006) DOI: 10.1016/S1570-7946(06)80180-X

Hirokazu Sugiyama, Masahiko Hirao "Development of process design methodology based on Life Cycle Assessment" In. B. Chen & A. Westerberg (Eds.): 8th international symposium on Process Systems Engineering, Elsevier, Computer Aided Chemical Engineering, 15, pp. 624–629 (2003) DOI: 10.1016/S1570-7946(03)80614-4

Kensaku Matsunami, Sara Badr, Hirokazu Sugiyama "Design framework and tools for solid drug product manufacturing processes" In: A. Fytopoulos et al. (eds.), Optimization of Pharmaceutical Processes, Springer, Optimization and Its Applications, 189, 393–412 (2022) DOI: 10.1007/978-3-030-90924-6_15

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)

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)

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)

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)

Hirokazu Sugiyama*, "Hybrid-modeling approaches for the design and operation of pharmaceutical processes", The 3rd PSE state-of-the-art Workshop, 7–10 April 2024, Hangzhou Jinxi Hotel, Hangzhou, China

Hirokazu Sugiyama*, "Bridging PSE and pharma: Challenges and opportunities for modeling, simulation, and optimization", Keynote lecture, 11th World Congress of Chemical Engineering (WCCE11), 10–6 June 2023, UCA Convention Center, Buenos Aires, Argentina

Hirokazu Sugiyama*, "Role of physical, statistical, and hybrid modelling approaches for pharmaceutical manufacturing", PSE Beacons, PSE Asia 2022, 10–14 December 2022, IIT Madras (Online), India

Hirokazu Sugiyama* "Pharma PSE: a multiscale approach for reimagining pharmaceutical manufacturing", Keynote lecture, The 14th International Symposium on Process Systems Engineering (PSE 2021+), 19–23 June 2022, Kyoto University Clock Tower Centennial Hall, Kyoto, Japan/Virtual meeting

Hirokazu Sugiyama* "Process Systems Engineering for Pharmaceutical Process Design and Operation", Keynote lecture, 2019 3rd International Conference on Functional Materials and Chemical Engineering (ICFMCE-2019), 15–17 December 2019, Chulalongkorn University, Bangkok, Thailand

Hirokazu Sugiyama* "Continuous Manufacturing from Decision-Making Perspective", Invited talk, 2019 ISPE Asia Pacific Pharmaceutical Manufacturing Conference, 30 September–1 October 2019, Marina Mandarin Singapore, Singapore

Hirokazu Sugiyama* "Process systems engineering for pharmaceutical manufacturing", Seminar at Prof. Morbidelli Group, Institute for Chemical and Bioengineering, 25 February 2019, ETH Zurich Hönggerberg, Zurich, Switzerland

Hirokazu Sugiyama* "Roles of process systems engineering in the design and operation of pharmaceutical manufacturing processes", Keynote lecture, The 8th International Symposium on Design, Operation, and Control of Chemical Processes (PSE Asia 2019), 13–16 January 2019, Chulalongkorn University, Bangkok, Thailand

Hirokazu Sugiyama* "Process systems engineering for pharmaceutical manufacturing", KIChE-SCEJ Joint Symposium, 25 October 2018, Daegu EXCO, Daegu, Korea

Hirokazu Sugiyama* "Decision support tools for pharmaceutical production" Seminar, Institute for Chemical and Bioengineering, 17 January 2018, ETH Zurich Hönggerberg, Zurich, Switzerland

Hirokazu Sugiyama* "Research needs and opportunities for process systems engineering in pharmaceutical manufacturing" keynote, 6th Conference on Emerging Energy & Process Technology 2017 (CONCEPT 2017), 27 November 2017, Double Tree by Hilton Hotel, Johor Bahru, Malaysia

Hirokazu Sugiyama* "Pharma PSE: pharmaceutical process systems engineering" Sustainable Chemistry – Farewell Symposium for the Safety & Environmental Technology Group, Institute for Chemical and Bioengineering, 7–8 September 2017, ETH Zurich Hönggerberg, Zurich, Switzerland

Hirokazu Sugiyama* "Design problem of pharmaceutical mzanufacturing processes" Seminarreihe Sicherheit und Umweltschutz in der Chemie, Institute for Chemical and Bioengineering, 24 November 2016, ETH Zurich Hönggerberg, Zurich, Switzerland

Hirokazu Sugiyama* "Role of modeling, simulation and optimization in the design of pharmaceutical manufacturing processes" Seminarreihe Sicherheit und Umweltschutz in der Chemie, Institute for Chemical and Bioengineering, 26 January 2016, ETH Zurich Hönggerberg, Zurich, Switzerland

Hirokazu Sugiyama* "Systems Engineering Approaches for Designing Pharmaceutical Manufacturing Processes" Pharma Process Congress, 27–28 October 2015, Palau de Congressos, Barcelona, Spain

Hirokazu Sugiyama* "Integration approach for realizing superior production processes in the pharmaceutical industry" Seminarreihe Sicherheit und Umweltschutz in der Chemie, Institute for Chemical and Bioengineering, 20 June 2014, ETH Zurich Hönggerberg, Zurich, Switzerland

Hirokazu Sugiyama* "Lean Six Sigma: framework and application in Roche Parenterals production" "Pharma Quality Excellence – ICH Q10 and EU GMP Chapter 1" organized by European Compliance Academy, 10–12 October 2012, Renaissance Wien Hotel, Vienna, Austria

Hirokazu Sugiyama* "How can European pharmaceutical manufacturers achieve "Japan Quality"?" "Japan Quality" conference organized by European Compliance Academy, 14–15 May 2012, Heidelberg Marriott Hotel, Heidelberg, Germany

Hirokazu Sugiyama* "Information on cultural differences between Europe and Japan" "Japan Quality" conference organized by European Compliance Academy, 14–15 May 2012, Heidelberg Marriott Hotel, Heidelberg, Germany

Hirokazu Sugiyama* "Wie kann der pharmazeutische Hersteller „Japan-Qualität" erzielen?" (in German) "Japan-Qualität" conference organized by Concept Heidelberg, 15–16 November 2011, Dorint Kongres-Hotel Mannheim, Heidelberg, Germany

Hirokazu Sugiyama*"Informationen zu kulturellen Unterschieden zwischen Europa und Japan" (in German) "Japan-Qualität" conference organized by Concept Heidelberg, 15–16 November 2011, Dorint Kongres-Hotel Mannheim, Heidelberg, Germany

Hirokazu Sugiyama* "Operational Excellence in sterile drug product manufacturing – case study in new Parenterals production in Kaiseraugst" "Modern Sterile Facilities 2011" organized by European Compliance Academy, 15–16 November 2011, Ramada Plaza Basel, Basel, Switzerland

Hirokazu Sugiyama* "How can European pharmaceutical manufacturers achieve "Japan Quality"?" "Japan Quality" conference organized by European Compliance Academy, 6–7 June 2011, Crowne Plaza Hotel Heidelberg, Heidelberg, Germany

Hirokazu Sugiyama* "Information on cultural differences between Europe and Japan" "Japan Quality" conference organized by European Compliance Academy, 6–7 June 2011, Crowne Plaza Hotel Heidelberg, Heidelberg, Germany

Hirokazu Sugiyama* "Systematische Prozessverbesserung in einem Sterilbetrieb am Beispiel der neuen Parenteralia-Produktion von F. Hoffmann-La Roche, Schweiz" (in German) "Aseptik-Konferenz 2011" organized by Concept Heidelberg, 1–2 March 2011, Dorint Kongress Hotel Mannheim, Mannheim, Germany

Hirokazu Sugiyama* "Wie kann der pharmazeutische Hersteller „Japan-Qualität" erzielen?" (in German) "Japan-Qualität" conference organized by Concept Heidelberg, 27–28 October 2010, Best Western Queens Hotel Karlsruhe, Karlsruhe, Germany

Hirokazu Sugiyama* "Informationen zu kulturellen Unterschieden zwischen Europa und Japan" (in German) "Japan-Qualität" conference organized by Concept Heidelberg, 27–28 October 2010, Best Western Queens Hotel Karlsruhe, Karlsruhe, Germany

Hirokazu Sugiyama* "How can European pharmaceutical manufacturers achieve "Japan Quality"?" "Japan Quality" conference organized by European Compliance Academy, 24–25 June 2010, Heidelberg Marriott Hotel, Heidelberg, Germany

Hirokazu Sugiyama* "Information on cultural differences between Europe and Japan" "Japan Quality" conference organized by European Compliance Academy, 24–25 June 2010, Heidelberg Marriott Hotel, Heidelberg, Germany

Hirokazu Sugiyama* "Initiating continuous improvement at Roche's new Galenical manufacturing facility in Kaiseraugst" Seminarreihe Sicherheit und Umweltschutz in der Chemie, Institute for Chemical and Bioengineering, 13 November 2009, ETH Zurich Hönggerberg, Zurich, Switzerland

Hirokazu Sugiyama* "Wie kann der pharmazeutische Hersteller „Japan-Qualität" erzielen?" (in German) "Japan-Qualität" conference organized by Concept Heidelberg, 4–5 November 2009, Best Western Queens Hotel Karlsruhe, Karlsruhe, Germany

Hirokazu Sugiyama* "Informationen zu kulturellen Unterschieden zwischen Europa und Japan" (in German) "Japan-Qualität" conference organized by Concept Heidelberg, 4–5 November 2009, Best Western Queens Hotel Karlsruhe, Karlsruhe, Germany

Hirokazu Sugiyama* "A Decision-Making Framework for Chemical Process Development Integrating Environmental, Health and Safety Aspects" Seminarreihe Sicherheit und Umweltschutz in der Chemie, Institute for Chemical and Bioengineering, 26 January 2007 (date changed), ETH Zurich Hönggerberg, Zurich, Switzerland

Hirokazu Sugiyama* "A new inventory data model and method for uncertainty evaluation in Life Cycle Assessment" International workshop on LCI-Quality, 20–21 October 2003, Forschungszentrum Karlsruhe, Karlsruhe, Germany