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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08:25 - 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
    Navigating China’s Evolving Regulatory Landscape and Bridging it with Global Development
    配合中國不斷變化的監管情勢並銜接全球發展
    • Wendy Yan - MBA, former SVP & Global Head of Regulatory Affairs, BeiGene
    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
      Adopting AI, Automation, and Advanced Analytics
      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
      Regulatory & CMC Strategies for Emerging Modalities
      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
      Adopting AI, Automation, and Advanced Analytics
      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
      Regulatory & CMC Strategies for Emerging Modalities
      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
      Adopting AI, Automation, and Advanced Analytics
      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
      Regulatory & CMC Strategies for Emerging Modalities
      新興模式上的監管和CMC策略
      Building a Harmonized CMC and Regulatory Framework for Emerging Modalities to Accelerate Their Development and Approval
      建立統一的 CMC 和監管框架，以加快新興模式的開發和審批
      • A Representative from Cell & Gene Catalyst, (pending)
      12:15 - 12:4530 分鐘
      Adopting AI, Automation, and Advanced Analytics
      AI、自動化和高級分析的引進
      Scientific Track Presentation
      科學專題簡報
        12:15 - 12:4530 分鐘
        Regulatory & CMC Strategies for Emerging Modalities
        新興模式上的監管和CMC策略
        Scientific Track Presentation
        科學專題簡報
          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
            Achievements in Intensified, Continuous, and Sustainable Bioprocessing
            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
            Regulatory & CMC Strategies for Emerging Modalities
            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
              Achievements in Intensified, Continuous, and Sustainable Bioprocessing
              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
              Regulatory & CMC Strategies for Emerging Modalities
              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 Team Lead, Nestlé Research
              14:30 - 15:0030 分鐘
              Achievements in Intensified, Continuous, and Sustainable Bioprocessing
              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 - Integrated Early Process Development Head, Takeda Pharmaceutical Company Limited
              14:30 - 15:0030 分鐘
              Regulatory & CMC Strategies for Emerging Modalities
              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
              Achievements in Intensified, Continuous, and Sustainable Bioprocessing
              強化、連續和永續生物加工方面的成就
              Panel Discussion - Impact of Sustainability Initiatives
              小組討論 - 對永續發展措施的影響
              • Yuki Abe, Ph.D., - Director, BioPharm Services Ltd.
              15:00 - 15:3030 分鐘
              Regulatory & CMC Strategies for Emerging Modalities
              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
              Achievements in Intensified, Continuous, and Sustainable Bioprocessing
              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
                Regulatory & CMC Strategies for Emerging Modalities
                新興模式上的監管和CMC策略
                Scientific Track Presentation
                科學專題簡報
                  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
                    Next Generation Bioprocessing, Digitalisation and Facilities of the Future
                    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 - Purification Process Development, Takeda Pharmaceutical Company Limited
                    16:30 - 17:0030 分鐘
                    Development, Production and Validation Strategies for Emerging Modalities
                    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
                    Next Generation Bioprocessing, Digitalisation and Facilities of the Future
                    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.
                    17:00 - 17:3030 分鐘
                    Development, Production and Validation Strategies for Emerging Modalities
                    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
                    Next Generation Bioprocessing, Digitalisation and Facilities of the Future
                    下一代生物加工、數位化和未來的設施
                    Panel Discussion: Asia's Bioprocessing Boom: Integrating Digitalization and Navigating Geopolitical Investment Strategies
                    小組討論：亞洲生物加工的急速成長：整合數位化及引領地緣政治投資策略
                    • Daisuke Kajihara - Senior Director of Bioprocess Technology Research Laboratories, Daiichi Sankyo Co., Ltd., Japan
                    17:30 - 18:0030 分鐘
                    Development, Production and Validation Strategies for Emerging Modalities
                    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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