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） – 主要会议 第2天 - 日本时间（GMT+09:00）

2025年10月22日（星期三） – 主要会议 第2天 - 日本时间（GMT+09:00）
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08:30 - 08:355分
Optimizing Efficiency & Quality Control While Reducing Cost of Manufacturing
降低制造成本的同时优化效率和品质控制
Chairperson’s Opening Remarks: Optimizing Efficiency & Quality Control While Reducing Cost of Manufacturing
主席开场致词：降低制造成本的同时优化效率和品质控制
  • Scott Wheelwright, PhD - Co-Founder and President, BEI
08:30 - 08:355分
Global Regulatory Alignment and Harmonization
全球监管协调与统一
Chairperson’s Welcome and Opening Remarks: Global Regulatory Alignment and Harmonization
主席致欢迎词及开幕词：全球监管协调与统一
    08:35 - 09:0530分
    Optimizing Efficiency & Quality Control While Reducing Cost of Manufacturing
    降低制造成本的同时优化效率和品质控制
    Accelerating Process Development and Reducing Manufacturing Cost for Biologics: A Case Study
    生物制剂上加速制程开发并降低制造成本：案例研究
      08:35 - 09:0530分
      Global Regulatory Alignment and Harmonization
      全球监管协调与统一
      Early Development of a Global Regulatory Strategy
      尽早制定全球监管战略
      • Jack Wong - CEO and Founder, Asia Regulatory Professionals Association (ARPA)
      09:05 - 09:3530分
      Optimizing Efficiency & Quality Control While Reducing Cost of Manufacturing
      降低制造成本的同时优化效率和品质控制
      Streamline Biologics Process Characterization and Control Strategy Development
      简化生物制剂制程表征与管理策略开发
      • Sadettin Ozturk, Ph.D. - Chief Technology Officer, STRM.BIO
      09:05 - 09:3530分
      Global Regulatory Alignment and Harmonization
      全球监管协调与统一
      Strategies for Meeting U.S. FDA Cell Therapy IND Requirements: A Case Study Approach
      满足美国 FDA 细胞疗法 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
      降低制造成本的同时优化效率和品质控制
      Optimizing Process Development and Clinical Production Efficiency with Continuous Improvement Projects
      透过持续改进专案优化制程开发和临床制造效率
        09:35 - 10:0530分
        Global Regulatory Alignment and Harmonization
        全球监管协调与统一
        How Startups and Researchers Can Collaborate with Government and Support Organizations
        新创公司和研究人员如何与政府和支援团体合作
        • 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
        海报/展览厅的交流茶歇
          10:45 - 11:1530分
          Adopting AI, Automation, and Advanced Analytics
          AI、自动化和高级分析的引进
          Leveraging AI And Advanced Analytics to Enhance Bioprocess Efficiency
          活用 AI 和高级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
          全球监管协调与统一
          Navigating China’s Evolving Regulatory Landscape and Bridging it with Global Development
          配合中国不断变化的监管情势并衔接全球发展
          • Wendy Yan - MBA, former SVP & Global Head of Regulatory Affairs, BeiGene
          11:15 - 11:4530分
          Adopting AI, Automation, and Advanced Analytics
          AI、自动化和高级分析的引进
          AI-Driven Bioprocessing: Innovations in Upstream and Downstream Development
          AI 驱动的生物加工：上下游开发创新
          • Mark Duerkop - Chief Executive Officer, Novasign, Austria
          11:15 - 11:4530分
          Global Regulatory Alignment and Harmonization
          全球监管协调与统一
          Ensuring Quality and Safety for Cell & Gene Therapy Products Under Evolving Guidelines
          根据不断发展的指导方针确保细胞和基因治疗产品的品质和安全
            11:45 - 12:1530分
            Adopting AI, Automation, and Advanced Analytics
            AI、自动化和高级分析的引进
            The Future of Biopharma: AI-Enabled Automation and Continuous Processing for Faster, Smarter Production
            生物制药的未来：AI 支援的自动化和连续处理，实现快速智慧生产
            • Mrinal Bachute - Head Industry Connect, Associate Professor, Symbiosis Institute of Technology, Symbiosis International University
            11:45 - 12:1530分
            Global Regulatory Alignment and Harmonization
            全球监管协调与统一
            Global Regulatory Strategy, Policy Harmonization, and Bridging Japan’s Requirements with Global Development Programs
            将全球性监管策略、政策协调以及日本要求与全球发展计划结合
              12:15 - 12:4530分
              Adopting AI, Automation, and Advanced Analytics
              AI、自动化和高级分析的引进
              Scientific Track Presentation
              科学专题简报
                12:15 - 12:4530分
                Global Regulatory Alignment and Harmonization
                全球监管协调与统一
                Scientific Track Presentation
                科学专题简报
                  12:45 - 13:5570分
                  Luncheon in the Poster/Exhibit Hall
                  海报/展览厅的午餐会
                    13:55 - 14:005分
                    Achievements in Intensified, Continuous, and Sustainable Bioprocessing
                    强化、连续和永续生物加工方面的成就
                    Chairperson’s Remarks: Achievements in Intensified, Continuous, and Sustainable Bioprocessing
                    主席致辞：强化、连续和永续生物加工方面的成就
                      13:55 - 14:005分
                      Regulatory & CMC Strategies for Emerging Modalities
                      新兴模式上的监管和CMC策略
                      Chairperson’s Remarks: Regulatory & CMC Strategies for Emerging Modalities
                      主席致辞：新兴模式上的监管和CMC策略
                        14:00 - 14:3030分
                        Achievements in Intensified, Continuous, and Sustainable Bioprocessing
                        强化、连续和永续生物加工方面的成就
                        Enabling Robust Continuous Biomanufacturing Using Digital Twins
                        利用数位孪生实现稳健的连续生物制造
                        • Christoph Herwig - Founder, Lisalis GmbH
                        14:00 - 14:3030分
                        Regulatory & CMC Strategies for Emerging Modalities
                        新兴模式上的监管和CMC策略
                        Future Direction on CMC of Next Generation ADCs
                        下一代ADC的CMC未来方向
                        • Gang Qin, PhD - President, GeneQuantum Healthcare (Suzhou) Co., Ltd.
                        14:30 - 15:0030分
                        Achievements in Intensified, Continuous, and Sustainable Bioprocessing
                        强化、连续和永续生物加工方面的成就
                        Sustainability Considerations in Regards to Geographical and Process Intensification
                        地理和流程强化方面的可持续性考虑事项
                        • Yuki Abe, Ph.D., - Director, BioPharm Services Ltd.
                        14:30 - 15:0030分
                        Regulatory & CMC Strategies for Emerging Modalities
                        新兴模式上的监管和CMC策略
                        Implementing Continuous Processing for Novel Modalities from Small to Large Scale - Overcoming Current and Planning for Future Challenges
                        从小规模到大规模，新模式上引进连续流程—克服当前挑战并规划未来
                        • Scott Wheelwright, PhD - Co-Founder and President, BEI
                        15:00 - 15:3030分
                        Achievements in Intensified, Continuous, and Sustainable Bioprocessing
                        强化、连续和永续生物加工方面的成就
                        Scientific Track Presentation
                        科学专题简报
                          15:00 - 15:3030分
                          Regulatory & CMC Strategies for Emerging Modalities
                          新兴模式上的监管和CMC策略
                          Scientific Track Presentation
                          科学专题简报
                            15:30 - 16:0030分
                            Networking Refreshment Break in Poster/Exhibit Hall
                            海报/展览厅的交流茶歇
                              16:00 - 16:3030分
                              Next Generation Bioprocessing, Digitalisation and Facilities of the Future
                              下一代生物加工、数位化和未来的设施
                              Establishing Flexible, Fully Disposable GMP Facility
                              建造灵活、完全一次性的 GMP 设施
                                16:00 - 16:3030分
                                Upstream and Downstream Case Studies for Emerging Modalities
                                新兴模式的上游和下游案例研究
                                Process Automation with AI Technology for Cell Therapies
                                透过细胞治疗用AI技术实现流程自动化
                                • 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、数位化和未来的设施
                                Designing High Productivity, Cost Effective Modular Bioprocessing Facilities - Successes and Lessons Learned
                                设计高产量且经济高效的优良模组化生物加工设施—成功案例与经验教训
                                  16:30 - 17:0030分
                                  Upstream and Downstream Case Studies for Emerging Modalities
                                  新兴模式的上游和下游案例研究
                                  Utilizing Semi-Automated, Intensified Processes for Allogeneic Cell Therapies
                                  活用同种异体细胞治疗用的半自动化、强化流程
                                    17:00 - 17:3030分
                                    Next Generation Bioprocessing, Digitalisation and Facilities of the Future
                                    下一代生物加工、数位化和未来的设施
                                    Global Strategies for Operating in an Evolving Landscape - Next Generation Bioprocessing, Digitalisation and Facilities of the Future
                                    不断变化的情势下有效的全球策略—下一代生物加工、数位化和未来设施
                                    • 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
                                    新兴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
                                    在下一代生物制剂生产上为强化制程和保证品质引进新平台的优势和挑战
                                      17:30 - 17:355分
                                      Close of BPI Asia 2025
                                      BPI Asia 2025闭幕

                                        * 活动内容有可能不事先告知作更动及调整。

                                        2025年10月21日（星期二） – 主要会议第1天
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