Informa
BioProcess International Asia
2025年10月20-22日
日本, 京都, Westin Miyako Kyoto

2025年10月22日（星期三） – 主要會議 第2天 - 日本時間（GMT+09:00）

2025年10月22日（星期三） – 主要會議 第2天 - 日本時間（GMT+09:00）
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08:00 - 08:2525分鐘
Registration and Coffee
報到・咖啡
    08:25 - 08:305 分鐘
    Plenary Session - Global Regulatory Alignment and Harmonization
    全體會議 - 全球監管協調與統一
    Chairperson’s Welcome and Opening Remarks: Global Regulatory Alignment and Harmonization
    主席致歡迎詞及開幕詞：全球監管協調與統一
      08:30 - 09:0030 分鐘
      Plenary Session - Global Regulatory Alignment and Harmonization
      全體會議 - 全球監管協調與統一
      Early Development of a Global Regulatory Strategy
      儘早制定全球監管戰略
      • Jack Wong - CEO and Founder, Asia Regulatory Professionals Association (ARPA)
      09:00 - 09:3030 分鐘
      Plenary Session - Global Regulatory Alignment and Harmonization
      全體會議 - 全球監管協調與統一
      Strategies for Meeting U.S. FDA Cell Therapy IND Requirements: A Case Study Approach
      滿足美國 FDA 細胞療法 IND 要求的策略：案例研究方法
      • Minghua Liu - CMC Consultant, Regulatory Affairs, Eliquent Life Sciences
      09:30 - 10:0030 分鐘
      Plenary Session - Global Regulatory Alignment and Harmonization
      全體會議 - 全球監管協調與統一
      Scientific Track Presentation: Sponsored by Genedata
      科學專題簡報 - Genedata提供
      • Mizue Hisano, PhD - Scientific Business Consultant, Genedata Bioprocess, Genedata
      10:00 - 10:4545 分鐘
      Networking Refreshment Break in Poster/Exhibit Hall
      海報/展覽廳的交流茶歇
        10:45 - 11:1530 分鐘
        BPI Track 1: Adopting AI, Automation, and Advanced Analytics
        BPI Track 1:AI、自動化和高級分析的引進
        PAT and AI in Biologics Production: Fact or Fiction
        生物制剂生产中的 PAT 和 AI：是事实还是虚构？
        • Niki Wong - Director, Global Technical Operations CMC, AbbVie Operations Singapore Pte Ltd
        10:45 - 11:1530 分鐘
        BPI Track 2: Regulatory & CMC Strategies for Emerging Modalities
        BPI Track 2:新興模式上的監管和CMC策略
        How Startups and Researchers Can Collaborate with Government and Support Organizations
        新創公司和研究人員如何與政府和支援團體合作
        • Maggie Lo - Senior VP, Life and Health Technology, Office for Attracting Strategic Enterprises
        11:15 - 11:4530 分鐘
        BPI Track 1: Adopting AI, Automation, and Advanced Analytics
        BPI Track 1:AI、自動化和高級分析的引進
        AI-Driven Bioprocessing: Innovations in Upstream and Downstream Development
        AI 驅動的生物加工：上下游開發創新
        • Mark Duerkop - Chief Executive Officer, Novasign, Austria
        11:15 - 11:4530 分鐘
        BPI Track 2: Regulatory & CMC Strategies for Emerging Modalities
        BPI Track 2:新興模式上的監管和CMC策略
        Future Direction on CMC of Next Generation ADCs
        下一代ADC的CMC未來方向
        • Gang Qin, PhD - President, GeneQuantum Healthcare (Suzhou) Co., Ltd.
        11:45 - 12:1530 分鐘
        BPI Track 1: Adopting AI, Automation, and Advanced Analytics
        BPI Track 1:AI、自動化和高級分析的引進
        The Future of Biopharma: AI-Enabled Automation and Continuous Processing for Faster, Smarter Production
        生物製藥的未來：AI 支援的自動化和連續處理，實現快速智慧生產
        • Mrinal Bachute - Head Industry Connect, Associate Professor, Symbiosis Institute of Technology, Symbiosis International University
        11:45 - 12:1530 分鐘
        BPI Track 2: Regulatory & CMC Strategies for Emerging Modalities
        BPI Track 2:新興模式上的監管和CMC策略
        Introducing Best Practice for Assessment and Qualification of Component Interchangeability in Single Use Assemblies
        • Yuusuke Saito - Engineer, Chugai Pharma manufacturing
        12:15 - 12:4530 分鐘
        BPI Track 1: Adopting AI, Automation, and Advanced Analytics
        BPI Track 1:AI、自動化和高級分析的引進
        Enabling AI-ready data for smarter bioprocess development
        • Sean Stowe - Principal Solutions Consultant, IDBS
        12:15 - 12:4530 分鐘
        BPI Track 2: Regulatory & CMC Strategies for Emerging Modalities
        BPI Track 2:新興模式上的監管和CMC策略
        Crafting Polysorbate Free Stable Biologics
          12:45 - 13:5570 分鐘
          Luncheon in the Poster/Exhibit Hall
          海報/展覽廳的午餐會
            13:55 - 14:005 分鐘
            BPI Track 1: Achievements in Intensified, Continuous, and Sustainable Bioprocessing
            BPI Track 1: 強化、連續和永續生物加工方面的成就
            Chairperson’s Remarks: Achievements in Intensified, Continuous, and Sustainable Bioprocessing
            主席致辭：強化、連續和永續生物加工方面的成就
            • Takashi Kaminagayoshi - Head of Biotherapeutics Process Development - Japan, Takeda Pharmaceutical Company Limited, Japan
            13:55 - 14:005 分鐘
            BPI Track 2: Regulatory & CMC Strategies for Emerging Modalities
            BPI Track 2:新興模式上的監管和CMC策略
            Chairperson’s Remarks: Regulatory & CMC Strategies for Emerging Modalities
            主席致辭：新興模式上的監管和CMC策略
              14:00 - 14:3030 分鐘
              BPI Track 1: Achievements in Intensified, Continuous, and Sustainable Bioprocessing
              BPI Track 1: 強化、連續和永續生物加工方面的成就
              Revolutionising Resource Efficiency Based on mAb Production for Different Process Options
              基於不同製程方案上的單株抗體生產，徹底革新資源效率
              • Yuki Abe, Ph.D., - Director, BioPharm Services Ltd.
              14:00 - 14:3030 分鐘
              BPI Track 2: Regulatory & CMC Strategies for Emerging Modalities
              BPI Track 2:新興模式上的監管和CMC策略
              An Automated Controlled Bioreactor Platform for Scalable 3D Expansion of iPSCs
              用於iPSC可擴展3D擴增上的自動化受控生物反應器平台
              • Andy Wiranata Wijaya - Bioprocess Development Lead, Nestlé Research
              14:30 - 15:0030 分鐘
              BPI Track 1: Achievements in Intensified, Continuous, and Sustainable Bioprocessing
              BPI Track 1: 強化、連續和永續生物加工方面的成就
              Building Next-Generation Single-Use, Digitally Enabled Biomanufacturing Facilities to Improve Efficiency and Sustainability
              構建下一代一次性、數位化生物製造設施，以提高效率和可持續性
              • Makoto Sadamitsu - Head, Integrated Early Process Development, Biotherapeutics Process Development, Takeda Pharmaceutical Company Limited
              14:30 - 15:0030 分鐘
              BPI Track 2: Regulatory & CMC Strategies for Emerging Modalities
              BPI Track 2:新興模式上的監管和CMC策略
              Qualifying and Validating Cell Counting and Viability Methods: Practical Considerations
              細胞計數和活力檢測方法的鑒定和驗證：實用的考慮要點
              • Christopher Bravery, Ph.D. - Principal Consultant, Consulting on Advanced Biologicals
              15:00 - 15:3030 分鐘
              BPI Track 1: Achievements in Intensified, Continuous, and Sustainable Bioprocessing
              BPI Track 1: 強化、連續和永續生物加工方面的成就
              Simplified Approached for Process Development and Validation for Continuous Purification Process
              • Tomonori Shiotani - Researcher, Chugai Pharmaceutical Co., Ltd.
              15:00 - 15:3030 分鐘
              BPI Track 2: Regulatory & CMC Strategies for Emerging Modalities
              BPI Track 2:新興模式上的監管和CMC策略
              Advancing mRNA-LNP GMP Manufacturing: Comparative Insights into Mixing, TFF Technologies, AI/ML Applications, and Scale-Up Approaches
              mRNA-LNP 的 GMP 生產進展：關於混合、TFF 技術、AI/ML 應用和放大方法的比較見解
              • Tomomi Sato - Associate Director, Parenteral DP, Drug Product & Device Development, Takeda Pharmaceutical Company Limited
              15:30 - 16:0030 分鐘
              BPI Track 1: Achievements in Intensified, Continuous, and Sustainable Bioprocessing
              BPI Track 1: 強化、連續和永續生物加工方面的成就
              Scientific Track Presentation
              科學專題簡報
                15:30 - 16:0030 分鐘
                BPI Track 2: Regulatory & CMC Strategies for Emerging Modalities
                BPI Track 2:新興模式上的監管和CMC策略
                Development of Biosimilar for ADC Therapeutics
                  16:00 - 16:3030 分鐘
                  Networking Refreshment Break in Poster/Exhibit Hall
                  海報/展覽廳的交流茶歇
                    16:30 - 17:0030 分鐘
                    BPI Track 1: Next Generation Bioprocessing, Digitalisation and Facilities of the Future
                    BPI Track 1: 下一代生物加工、數位化和未來的設施
                    Technological Platform for Process Automation and AI Process Development
                    • Atsushi Inoue, Ph.D. - Biological Technology Lead, Astellas Pharma Inc
                    16:30 - 17:0030 分鐘
                    BPI Track 2: Development, Production and Validation Strategies for Emerging Modalities
                    BPI Track 2: 新興模式的開發、生產和驗證策略
                    Utilizing Site-Specific Integration Cell Line Platform to Improve Product Quality and Development Efficiency for Complex Next-Gen Formats
                    活用基於特定位點整合的細胞株平台，提高複雜的下一代規格的產品質量和開發效率
                    • Changlin Dou - R&D President, Chief Operating Officer, Executive Board Member, Shandong Boan Biotechnology Co., Ltd, China
                    17:00 - 17:3030 分鐘
                    BPI Track 1: Next Generation Bioprocessing, Digitalisation and Facilities of the Future
                    BPI Track 1: 下一代生物加工、數位化和未來的設施
                    Digitally Integrated Product Life Cycle - The Role of End-to-End Digital Transformation
                    數位化整合的產品生命週期 – 端到端數位化轉型的作用
                    • Seishiro Sawamura - Principal Scientist, Digital CMC, Sustainability & Technology, Takeda Pharmaceutical Company Limited
                    17:00 - 17:3030 分鐘
                    BPI Track 2: Development, Production and Validation Strategies for Emerging Modalities
                    BPI Track 2: 新興模式的開發、生產和驗證策略
                    Implementing Continuous Processing for Novel Modalities from Small to Large Scale - Overcoming Current and Planning for Future Challenges
                    從小規模到大規模，新模式上引進連續流程—克服當前挑戰並規劃未來
                    • Scott Wheelwright, Ph.D. - Chairman, CTO & Co-Founder, BioChromatographix International Pte. Ltd. (BCI)
                    17:30 - 18:0030 分鐘
                    BPI Track 1: Next Generation Bioprocessing, Digitalisation and Facilities of the Future
                    BPI Track 1: 下一代生物加工、數位化和未來的設施
                    Key Technology Considerations for High-potency Biologics (Facility Layout, Single-use Technologies, Data-Driven Process Controls, Risk-based Containment Strategy)
                    高活性生物製劑的關鍵技術考慮因素（設施佈局、一次性技術、數據驅動的製程控制、基於風險的控制策略）
                    • Osamu Shirokizawa - President and CEO, Life Scientia Ltd.
                    17:30 - 18:0030 分鐘
                    BPI Track 2: Development, Production and Validation Strategies for Emerging Modalities
                    BPI Track 2: 新興模式的開發、生產和驗證策略
                    Process Automation with AI Technology for Cell Therapies
                    透過細胞治療用AI技術實現流程自動化
                    • Yasuhiro Takagi - Senior Director, Astellas Pharma Inc., Japan
                    18:00 - 18:055 分鐘
                    Close of BPI Asia 2025
                    BPI Asia 2025閉幕

                      * 活動內容有可能不事先告知作更動及調整。

                      2025年10月21日（星期二） – 主要會議第1天
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