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Development of innovative process design methodology for pharmaceutical manufacturing and tool implementation

Research Project

Project/Area Number 17H04964
Research Category

Grant-in-Aid for Young Scientists (A)

Allocation TypeSingle-year Grants
Research Field Reaction engineering/Process system
Research InstitutionThe University of Tokyo

Principal Investigator

Sugiyama Hirokazu  東京大学, 大学院工学系研究科(工学部), 准教授 (70701340)

Project Period (FY) 2017-04-01 – 2021-03-31
Project Status Completed (Fiscal Year 2020)
Budget Amount *help
¥18,330,000 (Direct Cost: ¥14,100,000、Indirect Cost: ¥4,230,000)
Fiscal Year 2020: ¥6,240,000 (Direct Cost: ¥4,800,000、Indirect Cost: ¥1,440,000)
Fiscal Year 2019: ¥6,630,000 (Direct Cost: ¥5,100,000、Indirect Cost: ¥1,530,000)
Fiscal Year 2018: ¥2,470,000 (Direct Cost: ¥1,900,000、Indirect Cost: ¥570,000)
Fiscal Year 2017: ¥2,990,000 (Direct Cost: ¥2,300,000、Indirect Cost: ¥690,000)
Keywords医薬品製造 / プロセス設計 / スーパーストラクチャー / 数理モデル / シミュレーション / シングルユース / 連続生産 / iPS細胞 / バイオ医薬品 / 固形剤 / ソフトウェア / 社会実装 / 医薬品開発 / アルゴリズム / 意思決定 / ソフトウェア実装 / 多目的評価 / 注射剤 / ヒトiPS細胞 / 多目的意思決定 / モデル化 / 感度解析 / 多目的プロセス設計 / データ駆動型 / 化学工学 / プロセスシステム工学 / ソフトウエア
Outline of Final Research Achievements

In this research, we worked on the development of design methods for pharmaceutical manufacturing processes, and the implementation of support tools. For sterile filling processes of biopharmaceutical injectables (compounding, sterile filtration, filling, etc.), a method was developed to support the selection of single-use and multi-use technologies, and a prototype version of the software was released online. For solid drug product manufacturing processes (mixing, granulation, drying, tableting, etc.), a superstructure was constructed considering continuous technology, and the design method and software were developed. For iPS cell freezing processes, models for determining design variables such as cooling temperature profiles were were developed, which could be applied to process design. These achievements could contribute to the systematization of pharmaceutical manufacturing process design.

Academic Significance and Societal Importance of the Research Achievements

本研究成果の学術的意義は、医薬品製造プロセスの設計に関して、従来あいまいだった目的関数、設計変数、制約条件を定義し、これらを定量的に扱うための数理モデルを構築したうえで、新しい設計のアプローチを示した点にある。固形剤や注射剤、幹細胞などの幅広い対象で、構築したモデルや手法を応用したことで、構築したアプローチの有用性が示された。また、ソフトウェアツールとしての実装は、実際のプロセス設計への応用に大きく貢献するものである。本研究成果は、医薬品製造プロセスのより迅速な設計や、新薬の早期上市と高効率プロセスでの生産といった、様々な社会的意義を持つものである。

Report

(5 results)
  • 2020 Annual Research Report   Final Research Report ( PDF )
  • 2019 Annual Research Report
  • 2018 Annual Research Report
  • 2017 Annual Research Report
  • Research Products

    (142 results)

All 2021 2020 2019 2018 2017 Other

All Int'l Joint Research (5 results) Journal Article (50 results) (of which Int'l Joint Research: 10 results,  Peer Reviewed: 32 results,  Open Access: 5 results) Presentation (82 results) (of which Int'l Joint Research: 31 results,  Invited: 27 results) Book (2 results) Remarks (2 results) Patent(Industrial Property Rights) (1 results)

  • [Int'l Joint Research] F. Hoffmann-La Roche(スイス)

    • Related Report
      2020 Annual Research Report
  • [Int'l Joint Research] エジンバラ大学(英国)

    • Related Report
      2018 Annual Research Report
  • [Int'l Joint Research] ロシュ(スイス)

    • Related Report
      2018 Annual Research Report
  • [Int'l Joint Research] ETH Zurich/F. Hoffmann-La Roche(Switzerland)

    • Related Report
      2017 Annual Research Report
  • [Int'l Joint Research] The University of Edinburgh(United Kingdom)

    • Related Report
      2017 Annual Research Report
  • [Journal Article] Computational screening of cryoprotective agents for regenerative medical products using quantum chemistry and molecular dynamics simulations2021

    • Author(s)
      Hayashi Yusuke, Nakajima Yuka, Sugiyama Hirokazu
    • Journal Title

      Cryobiology

      Volume: in press Pages: 101-109

    • DOI

      10.1016/j.cryobiol.2021.03.002

    • Related Report
      2020 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Model-based assessment of temperature profiles in slow freezing for human induced pluripotent stem cells2021

    • Author(s)
      Hayashi Yusuke, Horiguchi Ikki, Kino-oka Masahiro, Sugiyama Hirokazu
    • Journal Title

      Computers & Chemical Engineering

      Volume: 144 Pages: 107150-107150

    • DOI

      10.1016/j.compchemeng.2020.107150

    • Related Report
      2020 Annual Research Report
    • Peer Reviewed / Int'l Joint Research
  • [Journal Article] Model-based assessment of temperature profiles in slow freezing for human induced pluripotent stem cells2021

    • Author(s)
      Hayashi Yusuke, Horiguchi Ikki, Kino-oka Masahiro, Sugiyama Hirokazu
    • Journal Title

      Computers & Chemical Engineering

      Volume: 144 Issue: 11 Pages: 107150-107150

    • DOI

      10.1002/term.3127

    • Related Report
      2020 Annual Research Report
    • Peer Reviewed
  • [Journal Article] 固形剤製造プロセスの経済性評価シミュレーションとツール実装2021

    • Author(s)
      杉山 弘和, 松並 研作
    • Journal Title

      化学装置

      Volume: 1 Pages: 57-62

    • Related Report
      2020 Annual Research Report
  • [Journal Article] Apoptosis‐based method for determining lot sizes in the filling of human‐induced pluripotent stem cells2020

    • Author(s)
      Sugiyama Hirokazu, Shiokaramatsu Masaki, Kagihiro Masashi, Fukumori Kazuhiro, Horiguchi Ikki, Kino‐oka Masahiro
    • Journal Title

      Journal of Tissue Engineering and Regenerative Medicine

      Volume: 14 Issue: 9 Pages: 1641-1651

    • DOI

      10.1016/j.xphs.2020.05.024

    • Related Report
      2020 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Multi-stage and multi-objective decision-support tool for biopharmaceutical drug product manufacturing: Equipment technology evaluation2020

    • Author(s)
      Z?rcher Philipp, Shirahata Haruku, Badr Sara, Sugiyama Hirokazu
    • Journal Title

      Chemical Engineering Research and Design

      Volume: 161 Pages: 240-252

    • DOI

      10.1016/j.cherd.2020.07.004

    • Related Report
      2020 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Pharma PSE Spotlight 第12回:無菌製剤製造における除染プロセスとスケジューリングの統合設計2020

    • Author(s)
      藪田 啓奨, 杉山 弘和
    • Journal Title

      Pharm Tech Japan

      Volume: 36 Pages: 2421-2426

    • Related Report
      2020 Annual Research Report
  • [Journal Article] Pharma PSE Spotlight 第13回:ヒトiPS細胞の緩慢凍結プロセスにおける冷却温度プロファイルのモデルベースト評価2020

    • Author(s)
      林 勇佑, 杉山 弘和
    • Journal Title

      Pharm Tech Japan

      Volume: 37 Pages: 255-259

    • Related Report
      2020 Annual Research Report
  • [Journal Article] 固形製剤の製法設計のためのシミュレーションツール2020

    • Author(s)
      松並 研作, 杉山 弘和
    • Journal Title

      Pharm Tech Japan

      Volume: 36 Pages: 1257-1262

    • Related Report
      2020 Annual Research Report
  • [Journal Article] Integrated design of H2O2 decontamination processes and scheduling in sterile drug product manufacturing2020

    • Author(s)
      Keisho Yabuta, Haruka Futamura, Koji Kawasaki, Hirokazu Sugiyama
    • Journal Title

      Journal of Pharmaceutical Innovation

      Volume: accepted Issue: 1 Pages: 38-52

    • DOI

      10.1007/s12247-019-09410-7

    • Related Report
      2019 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Determining key parameters of continuous wet granulation for tablet quality and productivity: A case in ethenzamide2020

    • Author(s)
      Kensaku Matsunami, Takuya Nagato, Koji Hasegawa, Hirokazu Sugiyama
    • Journal Title

      International Journal of Pharmaceutics

      Volume: 579 Pages: 119160-119160

    • DOI

      10.1016/j.ijpharm.2020.119160

    • Related Report
      2019 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Superstructure-based process synthesis and economic assessment under uncertainty for solid drug product manufacturing2020

    • Author(s)
      Kensaku Matsunami, Fabian Sternal, Keita Yaginuma, Shuichi Tanabe, Hiroshi Nakagawa, Hirokazu Sugiyama
    • Journal Title

      BMC Chemical Engineering

      Volume: 2 Issue: 1 Pages: 6-6

    • DOI

      10.1186/s42480-020-0028-2

    • Related Report
      2019 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] Slow freezing process design for human induced pluripotent stem cells by modeling intracontainer variation2019

    • Author(s)
      Yusuke Hayashi, Ikki Horiguchi, Masahiro Kino-oka, Hirokazu Sugiyama
    • Journal Title

      Computers and Chemical Engineering

      Volume: 132 Pages: 106597-106597

    • DOI

      10.1016/j.compchemeng.2019.106597

    • Related Report
      2019 Annual Research Report
    • Peer Reviewed
  • [Journal Article] A distribution-based approach for determining lot sizes in the filling of human-induced pluripotent stem cells2019

    • Author(s)
      Hirokazu Sugiyama, Masaki Shiokaramatsu, Masahiro Kino-oka
    • Journal Title

      Regenerative Therapy

      Volume: 12 Pages: 94-101

    • DOI

      10.1016/j.reth.2019.04.012

    • Related Report
      2019 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] Dynamic modelling, simulation and economic evaluation of two CHO cell-based production modes towards developing biopharmaceutical manufacturing processes2019

    • Author(s)
      Haruku Shirahata, Samir Diab, Hirokazu Sugiyama, Dimitrios I. Gerogiorgis
    • Journal Title

      Chemical Engineering Research and Design

      Volume: 150 Pages: 218-233

    • DOI

      10.1016/j.cherd.2019.07.016

    • Related Report
      2019 Annual Research Report
    • Peer Reviewed / Int'l Joint Research
  • [Journal Article] Online decision-support tool "TECHoice" for the equipment technology choice in sterile filling processes of biopharmaceuticals2019

    • Author(s)
      Haruku Shirahata, Sara Badr, Yuki Shinno, Shuta Hagimori, Hirokazu Sugiyama
    • Journal Title

      Processes

      Volume: 7 Issue: 7 Pages: 448-448

    • DOI

      10.3390/pr7070448

    • Related Report
      2019 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] Integrated white-box models for designing freezing processes of human induced pluripotent stem cells considering diversity within a container2019

    • Author(s)
      Yusuke Hayashi, Ikki Horiguchi, Masahiro Kino-oka, Hirokazu Sugiyama
    • Journal Title

      Computer Aided Chemical Engineering

      Volume: 46 Pages: 877-882

    • DOI

      10.1016/b978-0-12-818634-3.50147-8

    • ISBN
      9780128186343
    • Related Report
      2019 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Dynamic modelling and simulation of Chinese hamster ovary (CHO) cell fermentation for advanced biopharmaceutical manufacturing2019

    • Author(s)
      Haruku Shirahata, Samir Diab, Hirokazu Sugiyama, Dimitrios I. Gerogiorgi
    • Journal Title

      Computer Aided Chemical Engineering

      Volume: 46 Pages: 673-678

    • DOI

      10.1016/b978-0-12-818634-3.50113-2

    • ISBN
      9780128186343
    • Related Report
      2019 Annual Research Report
    • Peer Reviewed / Int'l Joint Research
  • [Journal Article] Pharma PSE Spotlight 第8回: エテンザミドを用いた医薬品錠剤製造におけるバッチ・連続技術の大スケール実験的検討2019

    • Author(s)
      松並 研作, 杉山 弘和
    • Journal Title

      Pharm Tech Japan

      Volume: 35 Pages: 1533-1537

    • Related Report
      2019 Annual Research Report
  • [Journal Article] Pharma PSE Spotlight 第9回: バイオ医薬品無菌充填工程を対象とするオンライン技術選択支援ツール"TECHoice"2019

    • Author(s)
      白畑 春来, 杉山 弘和
    • Journal Title

      Pharm Tech Japan

      Volume: 35 Pages: 2605-2610

    • Related Report
      2019 Annual Research Report
  • [Journal Article] Pharma PSE Spotlight 第10回:容器内ばらつきのモデル化によるヒトiPS細胞の緩慢凍結プロセス設計2019

    • Author(s)
      林 勇佑, 杉山 弘和
    • Journal Title

      Pharm Tech Japan

      Volume: 35 Pages: 2965-2968

    • Related Report
      2019 Annual Research Report
  • [Journal Article] Pharma PSE Spotlight 第11回:経済性評価に基づく注射剤製造プロセスのロットサイズ決定2019

    • Author(s)
      山田 真弘, 杉山 弘和
    • Journal Title

      Pharm Tech Japan

      Volume: 36 Pages: 871-875

    • Related Report
      2019 Annual Research Report
  • [Journal Article] Pharma PSE Research at The University of Tokyo2019

    • Author(s)
      Hirokazu Sugiyama
    • Journal Title

      PD2M Newsletter

      Volume: 2 Pages: 1-1

    • Related Report
      2019 Annual Research Report
  • [Journal Article] Multiobjective decision-support tools for the choice between single-use and multi-use technologies in sterile filling of biopharmaceuticals2019

    • Author(s)
      Shirahata Haruku、Hirao Masahiko、Sugiyama Hirokazu
    • Journal Title

      Computers & Chemical Engineering

      Volume: 122 Pages: 114-128

    • DOI

      10.1016/j.compchemeng.2018.06.001

    • Related Report
      2018 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Data mining algorithm for pre-processing biopharmaceutical drug product manufacturing records2019

    • Author(s)
      Casola Gioele、Siegmund Christian、Mattern Markus、Sugiyama Hirokazu
    • Journal Title

      Computers & Chemical Engineering

      Volume: 124 Pages: 253-269

    • DOI

      10.1016/j.compchemeng.2018.12.001

    • Related Report
      2018 Annual Research Report
    • Peer Reviewed / Int'l Joint Research
  • [Journal Article] Alternative generation and multiobjective evaluation using a design framework: Case study on sterile filling processes of biopharmaceuticals2019

    • Author(s)
      Shirahata Haruku、Badr Sara、Dakessian Shant、Sugiyama Hirokazu
    • Journal Title

      Computers & Chemical Engineering

      Volume: 123 Pages: 286-299

    • DOI

      10.1016/j.compchemeng.2018.12.019

    • Related Report
      2018 Annual Research Report
    • Peer Reviewed / Int'l Joint Research
  • [Journal Article] Relevance of regulatory constraints in designing pharmaceutical manufacturing processes: A case study on waste solvent recovery2019

    • Author(s)
      Sugiyama Hirokazu、Morikawa Yusuke、Matsuura Mai、Xu Menghe
    • Journal Title

      Sustainable Production and Consumption

      Volume: 17 Pages: 136-147

    • DOI

      10.1016/j.spc.2018.09.003

    • Related Report
      2018 Annual Research Report
    • Peer Reviewed
  • [Journal Article] A large-scale experimental comparison of batch and continuous technologies in pharmaceutical tablet manufacturing using ethenzamide2019

    • Author(s)
      Matsunami Kensaku、Nagato Takuya、Hasegawa Koji、Sugiyama Hirokazu
    • Journal Title

      International Journal of Pharmaceutics

      Volume: 559 Pages: 210-219

    • DOI

      10.1016/j.ijpharm.2019.01.028

    • Related Report
      2018 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] Pharma PSE Spotlight 第7回: バイオ医薬品無菌充填におけるシングルユース・マルチユース技術の多目的選択支援ツール2019

    • Author(s)
      白畑 春来, 杉山 弘和
    • Journal Title

      Pharm Tech Japan

      Volume: 35 Pages: 377-383

    • Related Report
      2018 Annual Research Report
  • [Journal Article] Design-oriented regression models for H 2 O 2 decontamination processes in sterile drug product manufacturing considering rapidity and sterility2018

    • Author(s)
      Yabuta Keisho、Futamura Haruka、Kawasaki Koji、Hirao Masahiko、Sugiyama Hirokazu
    • Journal Title

      International Journal of Pharmaceutics

      Volume: 548 Issue: 1 Pages: 466-473

    • DOI

      10.1016/j.ijpharm.2018.06.055

    • Related Report
      2018 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Decision Support Method for the Choice between Batch and Continuous Technologies in Solid Drug Product Manufacturing2018

    • Author(s)
      Matsunami Kensaku、Miyano Takuya、Arai Hiroaki、Nakagawa Hiroshi、Hirao Masahiko、Sugiyama Hirokazu
    • Journal Title

      Industrial & Engineering Chemistry Research

      Volume: 57 Issue: 30 Pages: 9798-9809

    • DOI

      10.1021/acs.iecr.7b05230

    • Related Report
      2018 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] Approach for Multicriteria Equipment Redesign in Sterile Manufacturing of Biopharmaceuticals2018

    • Author(s)
      Zeberli Anicia、Casola Gioele、Badr Sara、Siegmund Christian、Mattern Markus、Sugiyama Hirokazu
    • Journal Title

      Journal of Pharmaceutical Innovation

      Volume: in press Issue: 1 Pages: 15-25

    • DOI

      10.1007/s12247-018-9355-8

    • Related Report
      2018 Annual Research Report
    • Peer Reviewed / Int'l Joint Research
  • [Journal Article] Models for Designing Hydrogen Peroxide Decontamination Processes in Sterile Drug Product Manufacturing2018

    • Author(s)
      Yabuta Keisho、Futamura Haruka、Kawasaki Koji、Hirao Masahiko、Sugiyama Hirokazu
    • Journal Title

      Computer Aided Process Engineering

      Volume: 43 Pages: 1613-1618

    • DOI

      10.1016/b978-0-444-64235-6.50281-3

    • Related Report
      2018 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Industrial Scale Experiments towards the Development of Process Evaluation Models for Continuous Pharmaceutical Tablet Manufacturing2018

    • Author(s)
      Matsunami Kensaku、Nagato Takuya、Hasegawa Koji、Hirao Masahiko、Sugiyama Hirokazu
    • Journal Title

      Computer Aided Process Engineering

      Volume: 43 Pages: 1655-1660

    • DOI

      10.1016/b978-0-444-64235-6.50288-6

    • Related Report
      2018 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Multilayer and Multiobjective Design Platform for Drug Product Manufacturing Processes of Biopharmaceuticals2018

    • Author(s)
      Shirahata Haruku、Dakessian Shant、Hirao Masahiko、Sugiyama Hirokazu
    • Journal Title

      Computer Aided Process Engineering

      Volume: 44 Pages: 301-306

    • DOI

      10.1016/b978-0-444-64241-7.50045-8

    • Related Report
      2018 Annual Research Report
    • Peer Reviewed / Int'l Joint Research
  • [Journal Article] Quantitative Analysis on the Relevance of Regulatory Constraints in Designing Pharmaceutical Manufacturing Processes2018

    • Author(s)
      Sugiyama Hirokazu、Morikawa Yusuke、Matsuura Mai、Xu Menghe
    • Journal Title

      Computer Aided Process Engineering

      Volume: 44 Pages: 2119-2124

    • DOI

      10.1016/b978-0-444-64241-7.50348-7

    • Related Report
      2018 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Economic Evaluation of Batch and Continuous Manufacturing Technologies for Solid Drug Products during Clinical Development2018

    • Author(s)
      Matsunami Kensaku、Tanabe Shuichi、Nakagawa Hiroshi、Hirao Masahiko、Sugiyama Hirokazu
    • Journal Title

      Computer Aided Process Engineering

      Volume: 44 Pages: 2131-2136

    • DOI

      10.1016/b978-0-444-64241-7.50350-5

    • Related Report
      2018 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Data mining-based algorithm for pre-processing biopharmaceutical manufacturing records2018

    • Author(s)
      Casola Gioele、Siegmund Christian、Mattern Markus、Sugiyama Hirokazu
    • Journal Title

      Computer Aided Process Engineering

      Volume: 44 Pages: 2263-2268

    • DOI

      10.1016/b978-0-444-64241-7.50372-4

    • ISBN
      9780444642417
    • Related Report
      2018 Annual Research Report
    • Peer Reviewed / Int'l Joint Research
  • [Journal Article] Pharma PSE Spotlight 第4回: 注射剤製造における賦形剤使用プロセスの多目的設計手法2018

    • Author(s)
      杉山 弘和
    • Journal Title

      Pharm Tech Japan

      Volume: 34 Pages: 300-304

    • Related Report
      2018 Annual Research Report
  • [Journal Article] Pharma PSE Spotlight 第5回: 無菌製剤製造における収率向上のためのプロセスモデル2018

    • Author(s)
      藪田 啓奨, 杉山 弘和
    • Journal Title

      Pharm Tech Japan

      Volume: 34 Pages: 1329-1334

    • Related Report
      2018 Annual Research Report
  • [Journal Article] 製剤と粒子設計: 意思決定の切り口からみた製剤の連続生産2018

    • Author(s)
      杉山 弘和, 松並 研作
    • Journal Title

      Pharm Tech Japan

      Volume: 34 Pages: 2261-2265

    • Related Report
      2018 Annual Research Report
  • [Journal Article] Pharma PSE Spotlight 第6回: 過酸化水素除染プロセスの多目的設計に向けた統計モデル2018

    • Author(s)
      藪田 啓奨, 杉山 弘和
    • Journal Title

      Pharm Tech Japan

      Volume: 34 Pages: 2941-2946

    • Related Report
      2018 Annual Research Report
  • [Journal Article] Uncertainty-conscious Methodology for Process Performance Assessment in Biopharmaceutical Drug Product Manufacturing2017

    • Author(s)
      Casola Gioele, Siegmund Christian, Mattern Markus, Sugiyama Hirokazu
    • Journal Title

      AIChE Journal

      Volume: 64 Issue: 4 Pages: 1272-1284

    • DOI

      10.1002/aic.16020

    • Related Report
      2017 Annual Research Report
    • Peer Reviewed / Int'l Joint Research
  • [Journal Article] Risk Evaluation Models for the Design of Parenterals Manufacturing Processes2017

    • Author(s)
      Haruku Shirahata, Masahiko Hirao, Hirokazu Sugiyama
    • Journal Title

      Computer Aided Chemical Engineering

      Volume: 40 Pages: 2791-2796

    • DOI

      10.1016/b978-0-444-63965-3.50467-0

    • Related Report
      2017 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Process Systems Engineering Approaches for Drug Product Manufacturing: from Tablets to Injectables2017

    • Author(s)
      Hirokazu Sugiyama, Kensaku Matsunami, Keisho Yabuta
    • Journal Title

      Computer Aided Chemical Engineering

      Volume: 40 Pages: 2785-2790

    • DOI

      10.1016/b978-0-444-63965-3.50466-9

    • Related Report
      2017 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Integrated Process Performance Assessment Considering Uncertainty in Biopharmaceutical Manufacturing Operations2017

    • Author(s)
      Gioele Casola, Christian Siegmund, Markus Mattern, Hirokazu Sugiyama
    • Journal Title

      Computer Aided Chemical Engineering

      Volume: 40 Pages: 2227-2232

    • DOI

      10.1016/b978-0-444-63965-3.50373-1

    • Related Report
      2017 Annual Research Report
    • Peer Reviewed / Int'l Joint Research
  • [Journal Article] Pharma PSE Spotlight 第1回:無菌製剤製造における製品ロス低減のための計画手法2017

    • Author(s)
      杉山 弘和, 伊藤 正晃
    • Journal Title

      Pharm Tech Japan

      Volume: 33 Pages: 975-979

    • Related Report
      2017 Annual Research Report
  • [Journal Article] Pharma PSE Spotlight 第2回: 注射剤製造におけるシングルユース・マルチユース技術の選択支援手法2017

    • Author(s)
      白畑 春来, 杉山 弘和
    • Journal Title

      Pharm Tech Japan

      Volume: 33 Pages: 1529-1535

    • Related Report
      2017 Annual Research Report
  • [Journal Article] Pharma PSE Spotlight 第3回: ISPE日本本部 Pharma PSE COPの紹介2017

    • Author(s)
      杉山 弘和
    • Journal Title

      Pharm Tech Japan

      Volume: 33 Pages: 2911-2916

    • Related Report
      2017 Annual Research Report
  • [Journal Article] 連続生産を対象とするプロセスシステム工学研究2017

    • Author(s)
      松並 研作, 杉山 弘和
    • Journal Title

      Pharm Tech Japan

      Volume: 33 Pages: 2619-2625

    • Related Report
      2017 Annual Research Report
  • [Presentation] Model-based design of freezing temperature profile for human induced pluripotent stem cells2020

    • Author(s)
      Yusuke Hayashi, Ikki Horiguchi, Masahiro Kino-oka, Hirokazu Sugiyama
    • Organizer
      The 57th Annual Meeting of the Society for Cryobiology (CRYO2020)
    • Related Report
      2020 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Multiobjective dynamic optimization of slow freezing processes for human induced pluripotent stem cells by modeling intracontainer condition2020

    • Author(s)
      Yusuke Hayashi, Ikki Horiguchi, Masahiro Kino-Oka, Hirokazu Sugiyama
    • Organizer
      The 30th European Symposium on Computer-Aided Process Engineering (ESCAPE-30)
    • Related Report
      2020 Annual Research Report
    • Int'l Joint Research
  • [Presentation] ヒトiPS細胞の緩慢凍結における温度プロファイルの最適化シミュレーション2020

    • Author(s)
      林 勇佑, 堀口 一樹, 紀ノ岡 正博, 杉山 弘和
    • Organizer
      化学工学会 第51回秋季大会
    • Related Report
      2020 Annual Research Report
  • [Presentation] 数値流体力学シミュレーションを用いたヒトiPS細胞緩慢凍結プロセスのスケールアップ検討2020

    • Author(s)
      林 勇佑, Scholz Benedikt, 杉山 弘和
    • Organizer
      第20回日本再生医療学会総会
    • Related Report
      2020 Annual Research Report
  • [Presentation] 連続生産を考慮した製法選択 Selection of production methods considering continuous manufacturing2020

    • Author(s)
      杉山 弘和
    • Organizer
      連続生産の実現・推進を考える会 特別講演会
    • Related Report
      2019 Annual Research Report
    • Invited
  • [Presentation] 医薬品製造プロセスにおけるAI活用2020

    • Author(s)
      杉山 弘和
    • Organizer
      AI・IoT・ビッグデータ活用の基礎とプロセスへの実装
    • Related Report
      2019 Annual Research Report
    • Invited
  • [Presentation] プロセスの視点から見た過酸化水素除染:迅速性と連続性2020

    • Author(s)
      杉山 弘和
    • Organizer
      第8回 最新の医薬、再生医療に関するGMP、技術動向を考える会
    • Related Report
      2019 Annual Research Report
    • Invited
  • [Presentation] 無菌製剤製造における過酸化水素除染プロセスのモデルベースト設計2020

    • Author(s)
      藪田 啓奨, 二村 はるか, 川崎 康司, 杉山 弘和
    • Organizer
      化学工学会第85年会
    • Related Report
      2019 Annual Research Report
  • [Presentation] CFDシミュレーションを用いたヒトiPS細胞緩慢凍結プロセスのスケールアップ検討2020

    • Author(s)
      林 勇佑, Scholz Benedikt, 杉山 弘和
    • Organizer
      化学工学会第85年会
    • Related Report
      2019 Annual Research Report
  • [Presentation] シングルユース技術・連続生産を考慮したバイオ医薬品製造プロセスの俯瞰的設計2020

    • Author(s)
      白畑 春来, Badr Sara, 杉山 弘和
    • Organizer
      化学工学会第85年会
    • Related Report
      2019 Annual Research Report
  • [Presentation] Analysis of the effects of process parameters on start-up operation in continuous wet granulation2020

    • Author(s)
      Matsunami Kensaku, Nopens Ingmar, Sugiyama Hirokazu, De Beer Thomas
    • Organizer
      化学工学会第85年会
    • Related Report
      2019 Annual Research Report
  • [Presentation] ヒトiPS細胞の緩慢凍結における温度プロファイルの最適化シミュレーション2020

    • Author(s)
      林 勇佑, 堀口 一樹, 紀ノ岡 正博, 杉山 弘和
    • Organizer
      化学工学会第85年会
    • Related Report
      2019 Annual Research Report
  • [Presentation] 原薬製造におけるバッチ・フロー合成の選択支援手法2020

    • Author(s)
      金 俊佑, 米倉 寛智, 渡邊 健朗, 吉川 覚, 中西 勇夫, 杉山 弘和
    • Organizer
      化学工学会第85年会
    • Related Report
      2019 Annual Research Report
  • [Presentation] 連続・バッチ方式を考慮した注射剤製造プロセスの設計手法2020

    • Author(s)
      山田 真弘, 吉岡 泰之, 中西 勇夫, 杉山 弘和
    • Organizer
      化学工学会第85年会
    • Related Report
      2019 Annual Research Report
  • [Presentation] Process Systems Engineering for Pharmaceutical Process Design and Operation2019

    • Author(s)
      Hirokazu Sugiyama
    • Organizer
      3rd International Conference on Functional Materials and Chemical Engineering (ICFMCE-2019)
    • Related Report
      2019 Annual Research Report
    • Int'l Joint Research / Invited
  • [Presentation] Continuous Manufacturing from Decision-Making Perspective2019

    • Author(s)
      Hirokazu Sugiyama
    • Organizer
      2019 ISPE Asia Pacific Pharmaceutical Manufacturing Conference
    • Related Report
      2019 Annual Research Report
    • Int'l Joint Research / Invited
  • [Presentation] 連続生産とプロセス設計2019

    • Author(s)
      杉山 弘和
    • Organizer
      第9回レギュラトリーサイエンス学会学術大会
    • Related Report
      2019 Annual Research Report
    • Invited
  • [Presentation] 製剤製造を対象とする多目的かつ実践的なプロセス設計手法の開発2019

    • Author(s)
      杉山 弘和
    • Organizer
      第17回技術講演会
    • Related Report
      2019 Annual Research Report
    • Invited
  • [Presentation] 製薬プロセスシステム工学と意思決定支援2019

    • Author(s)
      杉山 弘和
    • Organizer
      インターフェックスジャパン セミナー
    • Related Report
      2019 Annual Research Report
    • Invited
  • [Presentation] Data-driven predictive monitoring and operation support for change-over processes in biopharmaceutical drug product manufacturing2019

    • Author(s)
      Anicia Zeberli, Sara Badr, Christian Siegmund, Markus Mattern, Hirokazu Sugiyama
    • Organizer
      2019 AIChE Annual Meeting
    • Related Report
      2019 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Economic evaluation tool for holistic design of solid drug product manufacturing processes considering continuous technology2019

    • Author(s)
      Kensaku Matsunami, Fabian Sternal, Keita Yaginuma, Shuichi Tanabe, Hiroshi Nakagawa, Hirokazu Sugiyama
    • Organizer
      2019 AIChE Annual Meeting
    • Related Report
      2019 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Slow freezing process design for human induced pluripotent stem cells by modeling intracontainer variation2019

    • Author(s)
      Yusuke Hayashi, Ikki Horiguchi, Masahiro Kino-oka, Hirokazu Sugiyama
    • Organizer
      2019 AIChE Annual Meeting
    • Related Report
      2019 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Alternative generation and evaluation using a design framework: Case study on drug substance manufacturing processes of biopharmaceuticals2019

    • Author(s)
      Haruku Shirahata, Sara Badr, Hirokazu Sugiyama
    • Organizer
      2019 AIChE Annual Meeting
    • Related Report
      2019 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Simulation-based design of slow freezing processes for human induced pluripotent stem cells considering intracontainer variation2019

    • Author(s)
      Yusuke Hayashi, Ikki Horiguchi, Masahiro Kino-oka, Hirokazu Sugiyama
    • Organizer
      18th Asian Pacific Confederation of Chemical Engineering Congress (APCChE 2019)
    • Related Report
      2019 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Simultaneous design of process and scheduling for pharmaceutical decontamination2019

    • Author(s)
      Keisho Yabuta, Haruka Futamura, Koji Kawasaki, Hirokazu Sugiyama
    • Organizer
      18th Asian Pacific Confederation of Chemical Engineering Congress (APCChE 2019)
    • Related Report
      2019 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Machine learning applications for predictive operation support in change-over processes of biopharmaceutical drug product manufacturing2019

    • Author(s)
      Yusuke Hayashi, Ikki Horiguchi, Masahiro Kino-oka, Masahiko Hirao, Hirokazu Sugiyama
    • Organizer
      18th Asian Pacific Confederation of Chemical Engineering Congress (APCChE 2019)
    • Related Report
      2019 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Freeze-thaw process design of induced pluripotent stem cells using white-box models2019

    • Author(s)
      Yusuke Hayashi, Ikki Horiguchi, Masahiro Kino-oka, Masahiko Hirao, Hirokazu Sugiyama
    • Organizer
      The 29th European Symposium on Computer-Aided Process Engineering (ESCAPE-29)
    • Related Report
      2019 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Dynamic modelling and simulation of Chinese hamster ovary (CHO) cell fermentation for advanced biopharmaceutical manufacturing2019

    • Author(s)
      Haruku Shirahata, Samir Diab, Hirokazu Sugiyama, Dimitrios Gerogiorgis
    • Organizer
      The 29th European Symposium on Computer-Aided Process Engineering (ESCAPE-29)
    • Related Report
      2019 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Holistic and model-based design of oral drug manufacturing processes considering uncertainty in clinical development2019

    • Author(s)
      Kensaku Matsunami, Hirokazu Sugiyama
    • Organizer
      The 8th International Symposium on Design, Operation, and Control of Chemical Processes (PSE Asia 2019)
    • Related Report
      2018 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Model-based determination of lot-size in pharmaceutical injectable manufacturing2019

    • Author(s)
      Masahiro Yamada, Sara Badr, Shouko Fukuda, Manabu Nakaya, Yasuyuki Yoshioka, Masahiko Hirao, Hirokazu Sugiyama
    • Organizer
      The 8th International Symposium on Design, Operation, and Control of Chemical Processes (PSE Asia 2019)
    • Related Report
      2018 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Roles of process systems engineering in the design and operation of pharmaceutical manufacturing processes2019

    • Author(s)
      Hirokazu Sugiyama
    • Organizer
      The 8th International Symposium on Design, Operation, and Control of Chemical Processes (PSE Asia 2019)
    • Related Report
      2018 Annual Research Report
    • Int'l Joint Research / Invited
  • [Presentation] 連続生産を考慮した固形製剤製造プロセスの経済性評価2019

    • Author(s)
      松並 研作, 田邉 修一, 柳沼 啓太, 杉山 弘和
    • Organizer
      化学工学会 第84年会
    • Related Report
      2018 Annual Research Report
  • [Presentation] バイオ医薬品注射剤製造における装置技術選択のためのオンライン支援ツール2019

    • Author(s)
      白畑 春来, 新納 裕樹, 萩森 秀太, Badr Sara, 杉山 弘和
    • Organizer
      化学工学会 第84年会
    • Related Report
      2018 Annual Research Report
  • [Presentation] Industrial scale experiments towards the development of process evaluation models for continuous pharmaceutical tablet manufacturing2018

    • Author(s)
      Kensaku Matsunami, Takuya Nagato, Koji Hasegawa, Masahiko Hirao, Hirokazu Sugiyama
    • Organizer
      28th European Symposium on Computer Aided Process Engineering (ESCAPE-28)
    • Related Report
      2018 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Models for designing hydrogen peroxide decontamination processes in sterile drug product manufacturing2018

    • Author(s)
      Keisho Yabuta, Haruka Futamura, Koji Kawasaki, Masahiko Hirao, Hirokazu Sugiyama
    • Organizer
      28th European Symposium on Computer Aided Process Engineering (ESCAPE-28)
    • Related Report
      2018 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Data mining-based algorithm for pre-processing biopharmaceutical manufacturing records2018

    • Author(s)
      Gioele Casola, Christian Siegmund, Markus Mattern, Hirokazu Sugiyama
    • Organizer
      13th International Symposium on Process Systems Engineering (PSE 2018)
    • Related Report
      2018 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Quantitative analysis on the relevance of regulatory constraints in designing pharmaceutical manufacturing processes2018

    • Author(s)
      Hirokazu Sugiyama, Yusuke Morikawa, Mai Matsuura, Menghe Xu
    • Organizer
      13th International Symposium on Process Systems Engineering (PSE 2018)
    • Related Report
      2018 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Economic evaluation of batch and continuous manufacturing technologies for solid drug products during clinical development2018

    • Author(s)
      Kensaku Matsunami, Shuichi Tanabe, Hiroshi Nakagawa, Masahiko Hirao, Hirokazu Sugiyama
    • Organizer
      13th International Symposium on Process Systems Engineering (PSE 2018)
    • Related Report
      2018 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Multilayer and multiobjective design platform for drug product manufacturing processes of biopharmaceuticals2018

    • Author(s)
      Haruku Shirahata, Shant Dakessian, Masahiko Hirao, Hirokazu Sugiyama
    • Organizer
      13th International Symposium on Process Systems Engineering (PSE 2018)
    • Related Report
      2018 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Data-driven real-time operation support for decontamination processes in biopharmaceutical drug product manufacturing2018

    • Author(s)
      Anicia Zeberli, Sara Badr, Christian Siegmund, Markus Mattern, Hirokazu Sugiyama
    • Organizer
      2018 AIChE Annual Meeting
    • Related Report
      2018 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Multi-stage and multi-objective design tool for process design in sterile filling of biopharmaceuticals2018

    • Author(s)
      Haruku Shirahata, Philipp Zuercher, Sara Badr, Hirokazu Sugiyama
    • Organizer
      2018 AIChE Annual Meeting
    • Related Report
      2018 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Process modelling, simulation and optimisation for continuous biopharmaceutical manufacturing2018

    • Author(s)
      Samir Diab, Haruku Shirahata, Hirokazu Sugiyama, Dimitrios I. Gerogiorgis
    • Organizer
      2018 AIChE Annual Meeting
    • Related Report
      2018 Annual Research Report
    • Int'l Joint Research
  • [Presentation] プロセス情報の統合利用による注射剤製造のロットサイズ決定2018

    • Author(s)
      山田 真弘, Badr Sara, 福田 咲香, 中家 学, 吉岡 泰之, 平尾 雅彦, 杉山 弘和
    • Organizer
      化学工学会 第50回秋季大会
    • Related Report
      2018 Annual Research Report
  • [Presentation] 実験計画法に基づく錠剤連続製造のプロセス評価モデル2018

    • Author(s)
      松並 研作, 長門 琢也, 長谷川 浩司, 平尾 雅彦, 杉山 弘和
    • Organizer
      化学工学会 第50回秋季大会
    • Related Report
      2018 Annual Research Report
  • [Presentation] Framework for data-driven process improvement and operations support in biopharmaceutical drug product manufacturing2018

    • Author(s)
      Casola Gioele, Siegmund Christian, Mattern Markus, Sugiyama Hirokazu
    • Organizer
      化学工学会 第50回秋季大会
    • Related Report
      2018 Annual Research Report
  • [Presentation] Data-driven predictive monitoring and operation support for decontamination processes in biopharmaceutical manufacturing2018

    • Author(s)
      Zeberli Anicia, Badr Sara, Siegmund Christian, Mattern Markus, Sugiyama Hirokazu
    • Organizer
      化学工学会 第50回秋季大会
    • Related Report
      2018 Annual Research Report
  • [Presentation] バイオ医薬品注射剤製造におけるシングルユース・マルチユース技術の選択支援モデル2018

    • Author(s)
      杉山 弘和, 白畑 春来, Zuercher Philipp, Badr Sara
    • Organizer
      化学工学会 第50回秋季大会
    • Related Report
      2018 Annual Research Report
  • [Presentation] バイオ医薬品製造における技術選択のオンライン支援ツール2018

    • Author(s)
      白畑春来, 新納裕樹, 萩森秀太, Rizki Darmawan, Sara Badr, 杉山弘和
    • Organizer
      MATLAB EXPO 2018 Japan
    • Related Report
      2018 Annual Research Report
  • [Presentation] バイオ医薬品の製造プロセス設計における意思決定支援2018

    • Author(s)
      杉山 弘和
    • Organizer
      化学工学会関東支部 バイオプロセス講演・見学会
    • Related Report
      2018 Annual Research Report
    • Invited
  • [Presentation] 医薬品製造におけるシステムズ・アプローチの役割2018

    • Author(s)
      杉山 弘和
    • Organizer
      医療薬学フォーラム2018・第26回クリニカルファーマシーシンポジウム
    • Related Report
      2018 Annual Research Report
    • Invited
  • [Presentation] 医薬品製造のためのプロセスシステム工学2018

    • Author(s)
      杉山 弘和
    • Organizer
      第7回医薬品製造に関する技術動向を考える会
    • Related Report
      2018 Annual Research Report
    • Invited
  • [Presentation] バイオ医薬品の製造プロセス設計における意思決定支援-品質と効率の両立-2018

    • Author(s)
      杉山 弘和
    • Organizer
      国立医薬品食品衛生研究所特別講演会
    • Related Report
      2018 Annual Research Report
    • Invited
  • [Presentation] 製薬プロセスシステム工学の最近の進捗2018

    • Author(s)
      杉山 弘和
    • Organizer
      大阪大学細胞製造コトづくり講座
    • Related Report
      2018 Annual Research Report
    • Invited
  • [Presentation] 意思決定の切り口から見た連続生産2018

    • Author(s)
      杉山 弘和
    • Organizer
      ISPE日本本部 第17回冬季大会
    • Related Report
      2018 Annual Research Report
    • Invited
  • [Presentation] Process systems engineering for pharmaceutical manufacturing2018

    • Author(s)
      Hirokazu Sugiyama
    • Organizer
      KIChE-SCEJ Joint Symposium
    • Related Report
      2018 Annual Research Report
    • Int'l Joint Research / Invited
  • [Presentation] Research needs and opportunities for process systems engineering in pharmaceutical manufacturing2017

    • Author(s)
      Hiorkazu Sugiyama
    • Organizer
      6th Conference on Emerging Energy & Process Technology 2017 (CONCEPT 2017)
    • Related Report
      2017 Annual Research Report
    • Int'l Joint Research / Invited
  • [Presentation] Large-scale experimental comparison of batch and continuous technologies for pharmaceutical tablet manufacturing2017

    • Author(s)
      Kensaku Matsunami, Takuya Nagato, Koji Hasegawa, Masahiko Hirao, Hirokazu Sugiyama
    • Organizer
      AIChE annual meeting 2017
    • Related Report
      2017 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Risk evaluation models for the design of parenterals manufacturing processes2017

    • Author(s)
      Haruku Shirahata, Masahiko Hirao, Hirokazu Sugiyama
    • Organizer
      The 27th European Symposium on Computer-Aided Process Engineering (ESCAPE-27)
    • Related Report
      2017 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Process systems engineering approaches for drug product manufacturing: from tablets to injectables2017

    • Author(s)
      Hirokazu Sugiyama, Kensaku Matsunami, Keisho Yabuta
    • Organizer
      The 27th European Symposium on Computer-Aided Process Engineering (ESCAPE-27)
    • Related Report
      2017 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Integrated process performance assessment considering uncertainty in biopharmaceutical manufacturing operations2017

    • Author(s)
      Gioele Casola, Christian Siegmund, Markus Mattern, Hirokazu Sugiyama
    • Organizer
      The 27th European Symposium on Computer-Aided Process Engineering (ESCAPE-27)
    • Related Report
      2017 Annual Research Report
    • Int'l Joint Research
  • [Presentation] 製剤製造における装置技術情報を統合したプロセス合成2017

    • Author(s)
      杉山 弘和
    • Organizer
      化学工学会第49回秋季大会
    • Related Report
      2017 Annual Research Report
  • [Presentation] 医薬品錠剤のバッチ・連続製造プロセスにおける製品品質評価2017

    • Author(s)
      松並 研作, 長門 琢也, 長谷川 浩司, 平尾 雅彦, 杉山 弘和
    • Organizer
      化学工学会第49回秋季大会
    • Related Report
      2017 Annual Research Report
  • [Presentation] 注射剤製造プロセスの多階層・多目的設計プラットフォーム2017

    • Author(s)
      白畑 春来, Shant Dakessian, 平尾 雅彦, 杉山 弘和
    • Organizer
      化学工学会第49回秋季大会
    • Related Report
      2017 Annual Research Report
  • [Presentation] 医薬品製造におけるモデルベースト設計の役割2017

    • Author(s)
      杉山 弘和
    • Organizer
      2017年ISPE日本本部年次大会
    • Related Report
      2017 Annual Research Report
  • [Presentation] 医薬品・再生医療製品の製造におけるモデルベースト設計2017

    • Author(s)
      杉山 弘和
    • Organizer
      第16回日本再生医療学会総会
    • Related Report
      2017 Annual Research Report
    • Invited
  • [Presentation] 連続製造を対象とするプロセスシステム工学研究2017

    • Author(s)
      杉山 弘和
    • Organizer
      第25回静岡フォーラム・第50回研究交流セミナー
    • Related Report
      2017 Annual Research Report
    • Invited
  • [Presentation] プロセス選択肢としての連続生産2017

    • Author(s)
      杉山 弘和
    • Organizer
      ISPE日本本部 第16回冬季大会
    • Related Report
      2017 Annual Research Report
    • Invited
  • [Presentation] Pharma PSE 研究最前線 ~除染・シングルユース・連続製造~2017

    • Author(s)
      杉山 弘和
    • Organizer
      第6回最新の医薬・医療に関するGMP・技術動向を考える会 パイロットセミナー
    • Related Report
      2017 Annual Research Report
    • Invited
  • [Presentation] バイオプロセスイノベーションと情報統合2017

    • Author(s)
      杉山 弘和
    • Organizer
      INCHEM TOKYO 2017産学官マッチングフォーラム
    • Related Report
      2017 Annual Research Report
    • Invited
  • [Presentation] 医薬品製造における意思決定とスマート化 ~プロセス設計から継続的改善まで~2017

    • Author(s)
      杉山 弘和
    • Organizer
      バレオコンエグゼクティブセミナー2017
    • Related Report
      2017 Annual Research Report
    • Invited
  • [Presentation] Pharma PSE: Developing Novel Design Methodologies for Pharmaceutical Manufacturing Processes2017

    • Author(s)
      杉山 弘和
    • Organizer
      日本学術振興会プロセスシステム工学第143委員会 平成29年度第3回研究会
    • Related Report
      2017 Annual Research Report
    • Invited
  • [Presentation] 医薬品製造の課題とプロセスシステム工学による解決のアプローチ2017

    • Author(s)
      杉山 弘和
    • Organizer
      化学工学会開発型企業の会 2017年度第2回技術交流会
    • Related Report
      2017 Annual Research Report
    • Invited
  • [Presentation] アクティビティモデリング手法IDEF0の基礎2017

    • Author(s)
      杉山 弘和
    • Organizer
      産業技術総合研究所福島再生可能エネルギー研究所 セミナー
    • Related Report
      2017 Annual Research Report
    • Invited
  • [Presentation] Big data-platform for supporting design and operation of biopharmaceutical decontamination processes2017

    • Author(s)
      Zeberli Anicia, Roedl Thomas, Knueppel Stephanie, Siegmund Christian, Mattern Markus, Sugiyama Hirokazu
    • Organizer
      化学工学会第83年会
    • Related Report
      2017 Annual Research Report
  • [Presentation] 臨床開発時における固形製剤製造プロセスの設計手法2017

    • Author(s)
      松並 研作, 平尾 雅彦, 杉山 弘和
    • Organizer
      化学工学会第83年会
    • Related Report
      2017 Annual Research Report
  • [Presentation] 経済性評価に基づく注射剤製造プロセスのロットサイズ決定手法2017

    • Author(s)
      山田 真弘, 吉岡 泰之, 中家 学, 福田 咲香, 平尾 雅彦, 杉山 弘和
    • Organizer
      化学工学会第83年会
    • Related Report
      2017 Annual Research Report
  • [Presentation] 患者特性を考慮した残薬削減対策の選択支援手法2017

    • Author(s)
      原田 典和, 矢作 尚久, 平尾 雅彦, 杉山 弘和
    • Organizer
      化学工学会第83年会
    • Related Report
      2017 Annual Research Report
  • [Presentation] iPS細胞の産業化に向けた凍結・解凍プロセス設計2017

    • Author(s)
      林 勇佑, 紀ノ岡 正博, 堀口 一樹, 平尾 雅彦, 杉山 弘和
    • Organizer
      化学工学会第83年会
    • Related Report
      2017 Annual Research Report
  • [Presentation] Data-driven approaches for process improvement and operation support in biopharmaceutical drug product manufacturing2017

    • Author(s)
      Casola Gioele, Siegmund Christian, Mattern Markus, Sugiyama Hirokazu
    • Organizer
      化学工学会第83年会
    • Related Report
      2017 Annual Research Report
  • [Presentation] 医薬品の連続生産を対象とするプロセスシステム工学研究2017

    • Author(s)
      杉山 弘和
    • Organizer
      化学工学会第83年会
    • Related Report
      2017 Annual Research Report
  • [Presentation] プロセス特性を考慮した原薬製造における環境・健康・安全リスク低減手法2017

    • Author(s)
      福原 祥平, 西舘 修, 菊地 真, 高橋 美文, 平尾 雅彦, 杉山 弘和
    • Organizer
      化学工学会第83年会
    • Related Report
      2017 Annual Research Report
  • [Presentation] Decision-support tools for biopharmaceutical manufacturing2017

    • Author(s)
      Hirokazu Sugiyama
    • Organizer
      化学工学会第83年会
    • Related Report
      2017 Annual Research Report
    • Invited
  • [Book] 固形剤の連続製造プロセス設計と経済性評価2020

    • Author(s)
      松並 研作, 杉山 弘和
    • Total Pages
      9
    • Publisher
      技術情報協会
    • ISBN
      9784861048203
    • Related Report
      2020 Annual Research Report
  • [Book] "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2019

    • Author(s)
      杉山 弘和, 松並 研作
    • Total Pages
      10
    • Publisher
      シーエムシー出版
    • ISBN
      9784781314259
    • Related Report
      2019 Annual Research Report
  • [Remarks] 東京大学 平尾・杉山研ホームページ

    • URL

      http://www.pse.t.u-tokyo.ac.jp/index.html

    • Related Report
      2019 Annual Research Report
  • [Remarks] 平尾・杉山研究室

    • URL

      http://www.pse.t.u-tokyo.ac.jp/index.html

    • Related Report
      2018 Annual Research Report
  • [Patent(Industrial Property Rights)] 情報提供装置及びプログラム2018

    • Inventor(s)
      杉山 弘和, 白畑 春来, ツルヒャー フィリップ サミュエル
    • Industrial Property Rights Holder
      杉山 弘和, 白畑 春来, ツルヒャー フィリップ サミュエル
    • Industrial Property Rights Type
      特許
    • Industrial Property Number
      2018-163033
    • Filing Date
      2018
    • Related Report
      2018 Annual Research Report

URL: 

Published: 2017-04-28   Modified: 2022-01-27  

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