September 15 -18, 2025
Hynes Convention CenterBoston, USA
Key Sessions
Jianlin (Jim) Xu Xu
N-1 perfusion business case study
Sanofi
Thursday 18th September - Main Conference Day Three - ET (Eastern Time, GMT-05:00)
Thursday 18th September - Main Conference Day Three - ET (Eastern Time, GMT-05:00)
8:00am - 8:55am55 mins
Registration Break
Registration and Morning Coffee
8:55am - 9:00am5 mins
Cell Line Development & Engineering
Chairperson Remarks: Cell Line Development & Engineering
8:55am - 9:00am5 mins
Cell Culture & Upstream Processing
Chairperson Remarks: Cell Culture & Upstream Processing
8:55am - 9:00am5 mins
Downstream Processing
Chairperson Remarks: Downstream Processing
8:55am - 9:00am5 mins
Manufacturing Strategy & Digitalization
Chairperson Remarks: Manufacturing Strategy & Digitalization
8:55am - 9:00am5 mins
Analytical, Quality and Characterization
Chairperson Remarks
8:55am - 9:00am5 mins
Development of Emerging Cell & Gene Therapies
Chairperson's Opening Remarks: Development of Emerging Cell & Gene Therapies
8:55am - 9:00am5 mins
Cell Therapy Manufacturing & Analytics
Chairperson's Opening Remarks: Cell Therapy Manufacturing & Analytics
8:55am - 9:00am5 mins
Gene Therapy Manufacturing & Analytics
Chairperson's Opening Remarks: Gene Therapy Manufacturing & Analytics
- Rajeev Boregowda - Associate Director, Bioassay & Molecular Analytical Development, Genomic Medicine CMC, Sanofi
9:00am - 9:30am30 mins
Cell Line Development & Engineering
Fireside Chat: The CLD Toolbox: Your Essentials To a High Titre, High Quality and Rapid Cell Line
9:00am - 9:30am30 mins
Cell Culture & Upstream Processing
N-1 perfusion business case study
- Jianlin (Jim) Xu Xu - Global Head of Cell Culture Platform, Sanofi
9:00am - 9:30am30 mins
Downstream Processing
Development and implementation of PAT to support scale-up and process characterization of glycoconjugate vaccines
- Brenda Carillo-Conde - Group Leader, Pfizer
9:00am - 9:30am30 mins
Manufacturing Strategy & Digitalization
Noval Technology Applied to Biologics Manufacturing
9:00am - 9:30am30 mins
Analytical, Quality and Characterization
AI & ML in Analytics – What's Real and What's Hype?
9:00am - 9:30am30 mins
Development of Emerging Cell & Gene Therapies
Starting with the End in Mind: Designing Smart for Successful Cell & Gene Therapy Development
- Jeff Masten - Senior Vice President CMC, Secretome Therapeutics
9:00am - 9:30am30 mins
Cell Therapy Manufacturing & Analytics
Expanding Access to CAR-T cell Therapies by Manufacturing CRISPR Engineered Allogeneic Cell Therapies
- Justin Skoble - Vice President of Technical Development, Caribou Biosciences, Inc.
9:00am - 9:30am30 mins
Gene Therapy Manufacturing & Analytics
BLA Filing and Process Characterization
- Sarah Thomas - Senior Vice President, Quality, REGENXBIO Inc.
9:30am - 10:00am30 mins
Cell Line Development & Engineering
Overview of available automation tools for cell line development
9:30am - 10:00am30 mins
Cell Culture & Upstream Processing
Intensified and Continuous Processing: Enhancing Upstream Efficiency
9:30am - 10:00am30 mins
Downstream Processing
AI, Automation & Machine Learning – The Future of Bioprocessing
9:30am - 10:00am30 mins
Manufacturing Strategy & Digitalization
The Evolving Landscape of Analytical Profiles: Insights into ICH Q14
9:30am - 10:00am30 mins
Analytical, Quality and Characterization
Accelerating Digital Transformation in Analytical Workflows: Integrating Real-Time Data Across Platforms
9:30am - 10:00am30 mins
Development of Emerging Cell & Gene Therapies
Development of Next-Gen Cell & Gene Therapies - Gamma-Delta T Cell Engager Technology Case Study
- Kate Rochlin - Chief Operating Officer, IN8bio
9:30am - 10:00am30 mins
Cell Therapy Manufacturing & Analytics
Scale Up and Manufacturing Challenges of Next-Generation Allogeneic Cell Therapies
- Monica Raimo - Director, Product and Process Development, Glycostem Therapeutics
9:30am - 10:00am30 mins
Gene Therapy Manufacturing & Analytics
BLA Filing and Process Characterization
- Ying Cai - MSAT Executive Director, Ultragenyx Pharmaceutical
10:00am - 10:30am30 mins
Cell Line Development & Engineering
Sponsored Presentation: Breakthrough Automation Technologies for CLD and Revolutionizing Workflows
10:00am - 10:30am30 mins
Cell Culture & Upstream Processing
Sponsored Presentation: Improving Cell Culture Productivity Through Process Intensification Strategies
10:00am - 10:30am30 mins
Downstream Processing
Sponsored Presentation: The Role of Automation in Streamlining Downstream Processing
10:00am - 10:30am30 mins
Manufacturing Strategy & Digitalization
Sponsored Presentation: Managing Comparability and Commercialization
10:00am - 10:30am30 mins
Analytical, Quality and Characterization
The Regulatory Implications of AI/ML Biologics Analytics
10:00am - 10:30am30 mins
Development of Emerging Cell & Gene Therapies
Next-Gen Innovations: Cutting Edge Technologies Driving the Future of Cell and Gene Therapies
10:00am - 10:30am30 mins
Cell Therapy Manufacturing & Analytics
Scaling Up Allogeneic Cell Therapies: Cutting-Edge Technological Breakthroughs
10:00am - 10:30am30 mins
Gene Therapy Manufacturing & Analytics
Navigating Regulatory Pathways for Gene Therapy Success from R&D to BLA
10:30am - 11:15am45 mins
Morning Break
11:15am - 11:45am30 mins
Cell Line Development & Engineering
Cell Culture for Cell and Gene Therapy: Tailoring Upstream Processes for Therapeutic Applications
11:15am - 11:45am30 mins
Cell Culture & Upstream Processing
Process Intensification Strategies for Enhancing CHO-Based Biologic Production
- Andrei Arion - Associate Scientist, Cell Line and Upstream Process Development, Alexion, AstraZeneca Rare Disease
11:15am - 11:45am30 mins
Downstream Processing
Automated End-to-end Data Paradigm for Biologics Bioprocess Development
11:15am - 11:45am30 mins
Manufacturing Strategy & Digitalization
Building the Biomanufacturing Flexible Facility of the Future: Integrating Single-Use Systems and Automation
11:15am - 11:45am30 mins
Analytical, Quality and Characterization
Automated High-Throughput Assays: Revolutionizing Efficiency and Accelerating Discovery in Biopharma Analytics
11:15am - 11:45am30 mins
Development of Emerging Cell & Gene Therapies
Stromal-Free, GMP-Compatible Bioprocess for Generating Allogeneic CAR-・ｽ・ｽ・ｽ・ｽ T Cells from Cord Blood CD34+ HSPC
- Victor Manuel Diaz Cortes - Research Director, OneChain Immunotherapeutics S.L.
11:15am - 11:45am30 mins
Cell Therapy Manufacturing & Analytics
From Bench to Bedside: Developing a Roadmap for Large Scale Manufacturing of iPSCs
11:15am - 11:45am30 mins
Gene Therapy Manufacturing & Analytics
Advances in Analytical Method Development for the Characterization of AAVs
- Wei-Chiang Chen - Associate Director, BioProcess Analytics, Genomic Medicine Unit, Sanofi
11:45am - 12:15pm30 mins
Cell Line Development & Engineering
Overcoming Cell Culture Challenges for Bispecific Antibodies
11:45am - 12:15pm30 mins
Cell Culture & Upstream Processing
Monitoring cellular senescence in intensified CHO and HEK293 cultures, and its implications to productivity
11:45am - 12:15pm30 mins
Downstream Processing
In Silico Process Development for Less Work, More Accuracy – Merging Digital Twins & Machine Learning
11:45am - 12:15pm30 mins
Manufacturing Strategy & Digitalization
The Future of Manufacturing Operations
11:45am - 12:15pm30 mins
Analytical, Quality and Characterization
Automation in Action – Transforming Large-Scale Biomanufacturing
11:45am - 12:00pm15 mins
Development of Emerging Cell & Gene Therapies
INNOVATION HOUR: Development of Next-Gen Cell and Gene Therapies Case Studies
11:45am - 12:15pm30 mins
Cell Therapy Manufacturing & Analytics
Cryopreservation Strategies and Maintaining Cell Viability at Scale
- Yuechen Zhu - Staff Development Scientist, Bayer
11:45am - 12:15pm30 mins
Gene Therapy Manufacturing & Analytics
Upstream and Downstream Process Characterization of UX701 AAV Gene Therapy for Wilson Disease
- Jun Li - Associate Director – Upstream Process Development: Gene Therapy, Ultragenyx Pharmaceutical
12:00pm - 12:15pm15 mins
Development of Emerging Cell & Gene Therapies
INNOVATION HOUR: Case Study from Satellite Bio
- Marcus Lehmann - Associate Director, Drug Product Process Development, Satellite Bio
12:15pm - 12:45pm30 mins
Cell Line Development & Engineering
Sponsored Presentation: Successful Upstream Process Development for Bispecifics and ADCs
12:15pm - 12:45pm30 mins
Cell Culture & Upstream Processing
Sponsored Presentation: Advancing Volumetric Titres: Harnessing Cutting-Edge Technologies for Improved Productivity
12:15pm - 12:45pm30 mins
Downstream Processing
Sponsored Presentation: Process Optimization and Control at Scale
12:15pm - 12:45pm30 mins
Manufacturing Strategy & Digitalization
Sponsored Presentation: Meeting the Growing Demand for Biologics: Innovative Solutions for Capacity Expansion
12:15pm - 12:45pm30 mins
Analytical, Quality and Characterization
Sponsored Presentation: Transforming QC: Automation, High-Throughput Analytics, and Real-Time Release Testing for Next-Gen Biomanufacturing
12:15pm - 12:45pm30 mins
Cell Therapy Manufacturing & Analytics
Next Generation Preservation and Storage Solutions for Cell Therapy Products
12:15pm - 12:30pm15 mins
Gene Therapy Manufacturing & Analytics
Novel Analytical Technologies to Enhance Gene Therapy Product and Process Characterization
12:45pm - 2:00pm75 mins
Lunch
2:00pm - 2:30pm30 mins
Cell Line Development & Engineering
Regulatory Considerations in Cell Line Development for Biologics Production
2:00pm - 2:30pm30 mins
Cell Culture & Upstream Processing
Aligning with Regulatory Expectations in a Fast-Paced Environment
2:00pm - 2:30pm30 mins
Downstream Processing
Formulating for Success: Overcoming Viscosity Challenges in High Concentration Formulations
2:00pm - 2:30pm30 mins
Manufacturing Strategy & Digitalization
Streamlining Tech Transfer: Overcoming Data Challenges and Modernizing Processes
2:00pm - 2:30pm30 mins
Analytical, Quality and Characterization
Analytical Innovation Showcase: Preparing for the Next Wave of Biologics Characterizations
2:00pm - 2:30pm30 mins
Development of Emerging Cell & Gene Therapies
Development of Next-Gen Cell and Gene Therapies Case Studies
- Reagan Jarvis - Chief Executive Officer and Co-founder, Anocca
2:00pm - 2:30pm30 mins
Cell Therapy Manufacturing & Analytics
Visible Particles Within Cell Therapies- A Holistic and Strategic Approach to Characterize, Identify and De-Risk The Presence Of Visible Particulates In ATMP Drug Product Formulations
- Shankar Swaminathan, PhD - Team Lead, Associate Director Drug Product Development, Astellas Institute for Regenerative Medicine
2:00pm - 2:30pm30 mins
Gene Therapy Manufacturing & Analytics
Potency Assays – Ensuring Consistency and Reliability for Gene Therapies – From Development to Standardization
2:30pm - 3:00pm30 mins
Cell Line Development & Engineering
The Growing Complexity of Biotherapeutics
2:30pm - 3:00pm30 mins
Cell Culture & Upstream Processing
Accelerating Speed to Market in Upstream Cell Culture and Bioprocessing: Overcoming Challenges and Leveraging Technologies
2:30pm - 3:00pm30 mins
Downstream Processing
Translating Biologics from Lab to Market: A Downstream Perspective
2:30pm - 3:30pm60 mins
Manufacturing Strategy & Digitalization
Beyond the Contract: Optimizing CDMO Relationships for Accelerated Drug Development
2:30pm - 3:00pm30 mins
Analytical, Quality and Characterization
Fireside Chat: Implementing Next-Generation Analytical Technologies: Overcoming Challenges in Validation, Data Management, and Regulatory Compliance
- Seth Levy - Senior Director, Bioprocess Development, Modalis Therapeutics
2:30pm - 3:00pm30 mins
Development of Emerging Cell & Gene Therapies
Application of AI and Machine Learning in Gene Therapy Process Development and Manufacturing
- Jeron Chen - Head of Data Science and Payload Innovation, Voyager Therapeutics
2:30pm - 3:00pm30 mins
Cell Therapy Manufacturing & Analytics
Application of AI and Machine Learning in Gene Therapy Process Development and Manufacturing
- Jeron Chen - Head of Data Science and Payload Innovation, Voyager Therapeutics
2:30pm - 3:00pm30 mins
Gene Therapy Manufacturing & Analytics
Application of AI and Machine Learning in Gene Therapy Process Development and Manufacturing
- Jeron Chen - Head of Data Science and Payload Innovation, Voyager Therapeutics
3:00pm - 3:30pm30 mins
Downstream Processing
Sustainable Downstream Processing: Reducing Waste and Enhancing Environmental Impact
3:00pm - 3:30pm30 mins
Analytical, Quality and Characterization
Fireside Chat: Selecting and Applying Next-Generation Analytical Technologies: A Modality-Specific Approach
3:00pm - 3:30pm30 mins
Development of Emerging Cell & Gene Therapies
Harnessing AI & Digitalization for Cell and Gene Therapy Manufacturing – Unlocking Efficiency, Control and Scalability
3:00pm - 3:30pm30 mins
Cell Therapy Manufacturing & Analytics
Harnessing AI & Digitalization for Cell and Gene Therapy Manufacturing – Unlocking Efficiency, Control and Scalability
3:00pm - 3:30pm30 mins
Gene Therapy Manufacturing & Analytics
Harnessing AI & Digitalization for Cell and Gene Therapy Manufacturing – Unlocking Efficiency, Control and Scalability
3:30pm - 3:35pm5 mins
Close of Conference
* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。
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