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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08:30 - 08:355分
Optimizing Efficiency & Quality Control While Reducing Cost of Manufacturing
降低製造成本的同時優化效率和品質控制
Chairperson’s Opening Remarks: Optimizing Efficiency & Quality Control While Reducing Cost of Manufacturing
主席開場致詞：降低製造成本的同時優化效率和品質控制
  • Scott Wheelwright, PhD - Co-Founder and President, BEI
08:30 - 08:355分
Global Regulatory Alignment and Harmonization
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
    08:35 - 09:0530分
    Optimizing Efficiency & Quality Control While Reducing Cost of Manufacturing
    降低製造成本的同時優化效率和品質控制
    Accelerating Process Development and Reducing Manufacturing Cost for Biologics: A Case Study
    生物製劑上加速製程開發並降低製造成本：案例研究
      08:35 - 09:0530分
      Global Regulatory Alignment and Harmonization
      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)
      09:05 - 09:3530分
      Optimizing Efficiency & Quality Control While Reducing Cost of Manufacturing
      降低製造成本的同時優化效率和品質控制
      Streamline Biologics Process Characterization and Control Strategy Development
      簡化生物製劑製程表徵與管理策略開發
      • Sadettin Ozturk, Ph.D. - Chief Technology Officer, STRM.BIO
      09:05 - 09:3530分
      Global Regulatory Alignment and Harmonization
      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
      09:35 - 10:0530分
      Optimizing Efficiency & Quality Control While Reducing Cost of Manufacturing
      降低製造成本的同時優化效率和品質控制
      Optimizing Process Development and Clinical Production Efficiency with Continuous Improvement Projects
      透過持續改進專案優化製程開發和臨床製造效率
        09:35 - 10:0530分
        Global Regulatory Alignment and Harmonization
        全球監管協調與統一
        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
        10:05 - 10:4540分
        Networking Refreshment Break in Poster/Exhibit Hall
        海報/展覽廳的交流茶歇
          10:45 - 11:1530分
          Adopting AI, Automation, and Advanced Analytics
          AI、自動化和高級分析的引進
          Leveraging AI And Advanced Analytics to Enhance Bioprocess Efficiency
          活用 AI 和高級分析提高生物加工效率
          • Niki Wong - Director, Global Technical Operations CMC, AbbVie Operations Singapore Pte Ltd (pending)
          10:45 - 11:1530分
          Global Regulatory Alignment and Harmonization
          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
          11:15 - 11:4530分
          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
          Global Regulatory Alignment and Harmonization
          全球監管協調與統一
          Ensuring Quality and Safety for Cell & Gene Therapy Products Under Evolving Guidelines
          根據不斷發展的指導方針確保細胞和基因治療產品的品質和安全
            11:45 - 12:1530分
            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
            Global Regulatory Alignment and Harmonization
            全球監管協調與統一
            Global Regulatory Strategy, Policy Harmonization, and Bridging Japan’s Requirements with Global Development Programs
            將全球性監管策略、政策協調以及日本要求與全球發展計畫結合
              12:15 - 12:4530分
              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
                Global Regulatory Alignment and Harmonization
                全球監管協調與統一
                Scientific Track Presentation
                科學專題簡報
                  12:45 - 13:5570分
                  Luncheon in the Poster/Exhibit Hall
                  海報/展覽廳的午餐會
                    13:55 - 14:005分
                    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
                      13:55 - 14:005分
                      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
                        Achievements in Intensified, Continuous, and Sustainable Bioprocessing
                        強化、連續和永續生物加工方面的成就
                        Enabling Robust Continuous Biomanufacturing Using Digital Twins
                        利用數位孿生實現穩健的連續生物製造
                        • Christoph Herwig - Founder, Lisalis GmbH
                        14:00 - 14:3030分
                        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.
                        14:30 - 15:0030分
                        Achievements in Intensified, Continuous, and Sustainable Bioprocessing
                        強化、連續和永續生物加工方面的成就
                        Sustainability Considerations in Regards to Geographical and Process Intensification
                        地理和流程強化方面的可持續性考慮事項
                        • Yuki Abe, Ph.D., - Director, BioPharm Services Ltd.
                        14:30 - 15:0030分
                        Regulatory & CMC Strategies for Emerging Modalities
                        新興模式上的監管和CMC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, PhD - Co-Founder and President, BEI
                        15:00 - 15:3030分
                        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
                          15:00 - 15:3030分
                          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
                            15:30 - 16:0030分
                            Networking Refreshment Break in Poster/Exhibit Hall
                            海報/展覽廳的交流茶歇
                              16:00 - 16:3030分
                              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
                              Establishing Flexible, Fully Disposable GMP Facility
                              建造靈活、完全一次性的 GMP 設施
                                16:00 - 16:3030分
                                Upstream and Downstream Case Studies for Emerging Modalities
                                新興模式的上游和下游案例研究
                                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
                                16:30 - 17:0030分
                                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
                                Designing High Productivity, Cost Effective Modular Bioprocessing Facilities - Successes and Lessons Learned
                                設計高產量且經濟高效的優良模組化生物加工設施—成功案例與經驗教訓
                                  16:30 - 17:0030分
                                  Upstream and Downstream Case Studies for Emerging Modalities
                                  新興模式的上游和下游案例研究
                                  Utilizing Semi-Automated, Intensified Processes for Allogeneic Cell Therapies
                                  活用同種異體細胞治療用的半自動化、強化流程
                                    17:00 - 17:3030分
                                    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
                                    Global Strategies for Operating in an Evolving Landscape - Next Generation Bioprocessing, Digitalisation and Facilities of the Future
                                    不斷變化的情勢下有效的全球策略—下一代生物加工、數位化和未來設施
                                    • Daisuke Kajihara - Senior Director of Bioprocess Technology Research Laboratories, Daiichi Sankyo Co., Ltd., Japan
                                    17:00 - 17:3030分
                                    Upstream and Downstream Case Studies for Emerging Modalities
                                    新興模式的上游和下游案例研究
                                    Benefits and Challenges of Adopting Novel Platforms to Intensify Processes and Ensure Quality in Next-Generation Biologics Manufacturing
                                    在下一代生物製劑生產上為強化製程和保證品質引進新平台的優勢和挑戰
                                      17:30 - 17:355分
                                      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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