September 15 -18, 2025
Hynes Convention CenterBoston, USA
Key Sessions
Lina Chakrabarti
Automation in Cell Line Development
Astrazeneca
Jongyoon Han, Ph.D.
Monitoring cellular senescence in intensified CHO and HEK293 cultures, and its implications to productivity
Massachusetts Institute of Technology
Jianlin (Jim) Xu
KEYNOTE: N-1 Prefusion Platform Technology Development, Implementation, and Business Case Analysis in Commercial Manufacturing
Sanofi
Joseph Silhavy
Physics-based vs. machine-learning modeling of biomolecular separations properties
Pfizer
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)
7:45am - 8:10am25 mins
Registration Break
Registration and Morning Coffee
8:10am - 8:15am5 mins
BPI Keynote Plenary
Chairperson Remarks
8:15am - 8:50am35 mins
BPI Keynote Plenary
PLENARY KEYNOTE: Overcoming Challenges in Vaccine Manufacturing and Distribution
- Colette Ranucci - Vice President, Global Large Molecules, Technical Operations, Merck
8:50am - 9:00am10 mins
Cell Line Development & Engineering
Chairperson Remarks: Cell Line Development & Engineering
8:50am - 9:00am10 mins
Cell Culture & Upstream Processing
Chairperson Remarks: Cell Culture & Upstream Processing
8:50am - 9:00am10 mins
Downstream Processing
Chairperson Remarks: Downstream Processing
- Stefano Menegatti - Associate Professor, North Carolina State University
8:50am - 9:00am10 mins
Manufacturing Strategy & Digitalization
Chairperson Remarks: Manufacturing Strategy & Digitalization
8:50am - 9:00am10 mins
Analytical, Quality and Characterization
Chairperson Remarks
8:50am - 9:00am10 mins
Development of Emerging Cell & Gene Therapies
Chairperson’s Opening Remarks: Development of Emerging Cell & Gene Therapies
8:50am - 9:00am10 mins
Cell Therapy Manufacturing & Analytics
Chairperson’s Opening Remarks: Cell Therapy Manufacturing & Analytics
8:50am - 9:00am10 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
8:50am - 9:50am60 minsFocus Forum
Drug Product Formulation And Fill Finish
Formulation and Fill of Biologics
- Frank Riske, Ph.D. - Founder and Principal Consultant, Deep Dive Biotech Consulting
8:50am - 9:00am10 minsFocus Forum
External Manufacturing & CDMO Partnerships
Chair’s Welcome & Opening Remarks: External Manufacturing & CDMO Partnerships
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
KEYNOTE: N-1 Prefusion Platform Technology Development, Implementation, and Business Case Analysis in Commercial Manufacturing
- Jianlin (Jim) Xu - Global Head of Cell Culture Platform, Sanofi
9:00am - 9:30am30 mins
Downstream Processing
Physics-based vs. machine-learning modeling of biomolecular separations properties
- Joseph Silhavy - Senior Scientist, Pfizer
9:00am - 9:30am30 mins
Manufacturing Strategy & Digitalization
Noval Technology Applied to Biologics Manufacturing
- Wei Huang - President, Henlius Biopharmaceutical Ltd, China
9:00am - 9:30am30 mins
Analytical, Quality and Characterization
Fireside Chat: AI & ML in Analytics - What’s Real and What’s Hype?
- Kat Kozyrytska - Managing Director, Kozyrytska Consulting
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
- Francesca Vitelli, PhD - Former VP Cell Therapy and Viral Vector PD and MSAT, Intellia Therapeutics, Inc
- 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
Fast Forward - CMC Planning and Execution to Support an Accelerated Approval Pathway
- Sarah Thomas - Senior Vice President, Quality, REGENXBIO Inc.
9:00am - 9:30am30 minsFocus Forum
External Manufacturing & CDMO Partnerships
The Make vs. Buy Crossroads: Defining Your Optimal Outsourcing Strategy
9:10am - 9:30am20 mins
Innovation and Community Stage (Exhibit Hall)
SPEX Poster Showcase
9:30am - 10:00am30 mins
Cell Line Development & Engineering
Automation in Cell Line Development
- Lina Chakrabarti - Associate Principal Scientist, Astrazeneca
9:30am - 10:00am30 mins
Cell Culture & Upstream Processing
Streamlining CHO Expression Across Research, PD and Manufacturing for Speed to the Clinic
- Keshab Rijal - Principal Scientist, Amgen
9:30am - 10:00am30 mins
Downstream Processing
AI, Automation & Machine Learning - The Future of Bioprocessing
- Abraham Lenhoff - Allan P. Colburn Professor, University of Delaware
9:30am - 10:00am30 mins
Manufacturing Strategy & Digitalization
Transfer of PAT methods from the process development space to the GMP space
- Yuxin He - Sr Engineer II, Moderna
9:30am - 10:00am30 mins
Analytical, Quality and Characterization
Quantification of rAAV Genome Copies Using End-to-End Robotic and Data Automation
- Wei Zhang - Director, Analytical Development, Ultragenyx Gene Therapy
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
Closed-System Large-scale Manufacturing of Allogeneic Therapeutic NK Cells from Hematopoietic Stem Cells
- 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
9:30am - 10:00am30 minsFocus Forum
External Manufacturing & CDMO Partnerships
PANEL: Unlocking Value Through External Partnerships: Beyond Cost Savings
9:40am - 10:20am40 mins
Innovation and Community Stage (Exhibit Hall)
DREAM and Talent - Careers in Science
9:50am - 10:20am30 minsFocus Forum
Drug Product Formulation And Fill Finish
Sponsored Presentation: Stabilization of Biologics To Improve Efficacy and Reduce Degradation
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
Sponsored Presentation: 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
10:00am - 10:30am30 minsFocus Forum
External Manufacturing & CDMO Partnerships
Sponsored Presentation: Overcome Roadblocks to Expanding Manufacturing Capabilities through Strategic CDMO/Partner Collaboration
10:20am - 10:25am5 minsFocus Forum
Drug Product Formulation And Fill Finish
Chairperson Opening Remarks
- Shahid Uddin - Senior Director, Formulation Development and Laboratory Operations, CMC, Immunocore
10:20am - 10:30am10 mins
Innovation and Community Stage (Exhibit Hall)
SPEX Poster Showcase
10:40am - 11:25am45 mins
Break
Morning Break
11:25am - 11:55am30 mins
Cell Line Development & Engineering
Evaluation of a flow cytometry toolkit to assess cellular health of production cell lines during bioprocess development
- Daniel Burke - Senior Scientist, Merck
11:25am - 11:55am30 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
11:25am - 11:55am30 mins
Downstream Processing
Automated End-to-end Data Paradigm for Biologics Bioprocess Development
- Yi Li - Process Development Scientist, Amgen, Inc.
11:25am - 11:55am30 mins
Manufacturing Strategy & Digitalization
From Development to Submission: Streamlining CMC Processes
- Kimberly Larson - Principal Scientist, Boehringer Ingelheim
11:25am - 11:55am30 mins
Analytical, Quality and Characterization
Automated High-Throughput Assays: Revolutionizing Efficiency and Accelerating Discovery in Biopharma Analytics
- Marshall Ma - Research Fellow, Boston University
11:25am - 11:55am30 mins
Development of Emerging Cell & Gene Therapies
Stromal-Free, GMP-Compatible Bioprocess for Generating Allogeneic CAR-γδ T Cells from Cord Blood CD34+ HSPC
- Victor Manuel Diaz Cortes - Research Director, OneChain Immunotherapeutics S.L.
11:25am - 11:55am30 mins
Cell Therapy Manufacturing & Analytics
From Bench to Bedside: Developing a Roadmap for Large Scale Manufacturing of iPSCs
- Nicole Santimauro - Senior Engineer, Manufacturing Science and Technology, Century Therapeutics, Inc.
11:25am - 11:55am30 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
11:25am - 11:55am30 minsFocus Forum
Drug Product Formulation And Fill Finish
Developability assessment of biologics and formulation of novel molecules
- Shahid Uddin - Senior Director, Formulation Development and Laboratory Operations, CMC, Immunocore
11:25am - 11:55am30 minsFocus Forum
External Manufacturing & CDMO Partnerships
Decoding FDA Expectations: Ensuring GMP Compliance in Outsourced Manufacturing
11:55am - 12:25pm30 mins
Cell Line Development & Engineering
Development of an on-chip binding assay to select clones expressing high quality bispecific antibodies
- Shu Wang - Principal Investigator, Incyte
11:55am - 12:25pm30 mins
Cell Culture & Upstream Processing
Monitoring cellular senescence in intensified CHO and HEK293 cultures, and its implications to productivity
- Jongyoon Han, Ph.D. - Professor, PI of the Micro-Nanofluidic BioMEMS group at RLE, Massachusetts Institute of Technology
11:55am - 12:25pm30 mins
Downstream Processing
Characterization Tools for Process Understanding: Need for Simplicity, Focus and Speed
- Chris Barton - Director, Analytical Development, Takeda
11:55am - 12:25pm30 mins
Manufacturing Strategy & Digitalization
The Future of Manufacturing Operations
- A Representative from Biophorum - -, BioPhorum
11:55am - 12:25pm30 mins
Analytical, Quality and Characterization
Automation of Cell-Based Assays: Challenges and Strategic Approaches
- Divyanshu Malhotra - Senior Scientist, Genmab
11:55am - 12:10pm15 mins
Development of Emerging Cell & Gene Therapies
INNOVATION HOUR: Case Study from Cue Biopharma - Solid Tumours & Expanding Disease Areas (Autoimmune, Neurology, Cardiometabolic)
11:55am - 12:25pm30 mins
Cell Therapy Manufacturing & Analytics
Cryopreservation Development in Cell Therapy Manufacturing and Scale Up Challenges
- Yuechen Zhu - Staff Development Scientist, Bayer
11:55am - 12:25pm30 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
11:55am - 12:25pm30 minsFocus Forum
Drug Product Formulation And Fill Finish
Trace Metals, Major Impacts: Unveiling the Hidden Interactions in Monoclonal Antibody Formulations
- Laurence Whitty-Léveillé, Ph.D - Associate Principal Scientist, Merck & Co
11:55am - 12:25pm30 minsFocus Forum
External Manufacturing & CDMO Partnerships
PANEL: Building a Culture of Quality and Compliance Across Biopharma
12:10pm - 12:25pm15 mins
Development of Emerging Cell & Gene Therapies
INNOVATION HOUR: Case Study from Satellite Bio
- Marcus Lehmann - Associate Director, Drug Product Process Development, Satellite Bio
12:25pm - 12:55pm30 mins
Cell Line Development & Engineering
Sponsored Presentation: Successful Upstream Process Development for Bispecifics and ADCs
12:25pm - 12:55pm30 mins
Cell Culture & Upstream Processing
Perfusion Strategies for Viral Vector Production in HEK293 Cell Culture
- Omid Taghavian - Senior Scientist II, Fujifilm Irvine Scientific
12:25pm - 12:55pm30 mins
Downstream Processing
Sponsored Presentation: Process Optimization and Control at Scale
12:25pm - 12:55pm30 mins
Manufacturing Strategy & Digitalization
Sponsored Presentation: Meeting the Growing Demand for Biologics: Innovative Solutions for Capacity Expansion
12:25pm - 12:55pm30 mins
Analytical, Quality and Characterization
Sponsored Presentation: Transforming QC: Automation, High-Throughput Analytics, and Real-Time Release Testing for Next-Gen Biomanufacturing
12:25pm - 12:40pm15 mins
Development of Emerging Cell & Gene Therapies
INNOVATION HOUR: Sponsored Scientific Track Presentation
12:25pm - 12:55pm30 mins
Cell Therapy Manufacturing & Analytics
Next Generation Preservation and Storage Solutions for Cell Therapy Products
12:25pm - 12:55pm30 mins
Gene Therapy Manufacturing & Analytics
Novel Analytical Technologies to Enhance Gene Therapy Product and Process Characterization
12:25pm - 12:55pm30 minsFocus Forum
Drug Product Formulation And Fill Finish
Sponsored Presentation: Growth in Prefilled Syringes and Autoinjectors
12:25pm - 12:55pm30 minsFocus Forum
External Manufacturing & CDMO Partnerships
Sponsored Presentation: Bridging the Gap: Ensuring Seamless Technology Transfer and Successful Scale-Up with Your CDMO
12:40pm - 12:55pm15 mins
Development of Emerging Cell & Gene Therapies
INNOVATION HOUR: Sponsored Scientific Track Presentation
12:55pm - 2:05pm70 mins
Break
Lunch Networking
2:05pm - 2:10pm5 mins
Cell Line Development & Engineering
Chairperson Remarks
2:05pm - 2:10pm5 mins
Cell Culture & Upstream Processing
Chairperson Remarks
2:05pm - 2:10pm5 mins
Downstream Processing
Chairperson Remarks
2:05pm - 2:10pm5 mins
Manufacturing Strategy & Digitalization
Chairperson Remarks
2:05pm - 2:10pm5 mins
Analytical, Quality and Characterization
Chairperson Remarks
2:10pm - 2:40pm30 mins
Cell Line Development & Engineering
Hunting genomic hotspots in CHO genome for site specific integration
- Efecan Aral - Postdoctoral Associate, Cell Science and Technology, Sanofi
2:10pm - 2:40pm30 mins
Cell Culture & Upstream Processing
Aligning with Regulatory Expectations in a Fast-Paced Environment
2:10pm - 2:40pm30 mins
Downstream Processing
Challenges and Opportunities in Designing UFDF Processes for High Concentration Monoclonal Antibody Formulations
- Emma Cooper - Process Development Engineer, Regeneron
2:10pm - 2:40pm30 mins
Manufacturing Strategy & Digitalization
Streamlining Tech Transfer: Overcoming Data Challenges and Modernizing Processes
2:10pm - 2:40pm30 mins
Analytical, Quality and Characterization
Analytical Innovation Showcase: Preparing for the Next Wave of Biologics Characterizations
2:10pm - 2:40pm30 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
2:10pm - 2:40pm30 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
2:10pm - 2:40pm30 mins
Gene Therapy Manufacturing & Analytics
Potency Assays - Ensuring Consistency and Reliability for Gene Therapies - From Development to Standardization
- Pierre-Axel Vinot - Associate Director, CMC Portfolio Management, SparingVision
2:10pm - 2:40pm30 minsFocus Forum
Drug Product Formulation And Fill Finish
Ionic Liquids for High Concentration Biologics Formulations
- Samir Mitragotri - Hiller Professor of Bioengineering, John A. Paulson School of Engineering & Applied Sciences, Wyss Institute, Harvard University
2:10pm - 2:40pm30 minsFocus Forum
External Manufacturing & CDMO Partnerships
Crafting Effective RFPs and Conducting Comprehensive Due Diligence for CDMO Selection
2:40pm - 3:40pm60 mins
Cell Line Development & Engineering
PANEL DISCUSSION: The Growing Complexity of Biotherapeutics
- Jacqualyn Schulman, Ph.D. - Scientist, Cell Line Development & ‘Omics Biologics Development, Bristol-Myers Squibb
2:40pm - 3:40pm60 mins
Cell Culture & Upstream Processing
PANEL DISCUSSION: Accelerating Speed to Market in Upstream Cell Culture and Bioprocessing: Overcoming Challenges and Leveraging Technologies
- Sinead Dullaghan - Sr. Principal Scientist TSMS, Eli Lilly
- Sreejit Menon - Head of Life Sciences R & D North America, Croda
2:40pm - 3:10pm30 mins
Downstream Processing
Polysaccharide Drug Substance Production: Optimization and Scale-up of Purification Unit Operations
- Sidharth Razdan - Senior Scientist, Pfizer
2:40pm - 3:40pm60 mins
Manufacturing Strategy & Digitalization
PANEL DISCUSSION: Beyond the Contract: Optimizing CDMO Relationships for Accelerated Drug Development
2:40pm - 3:10pm30 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
- Shashi Prajapati - Director, Cell & Gene Therapies Analytical Development, Vertex Pharmaceuticals
2:40pm - 3:10pm30 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
2:40pm - 3:10pm30 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
2:40pm - 3:10pm30 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
2:40pm - 3:10pm30 minsFocus Forum
Drug Product Formulation And Fill Finish
The application of biophysical techniques to evaluate formulation stability for short term studies, the evaluation of stability profiles for lead candidate formulations in longer term studies
- Christina Vessely - Principal Consultant, CMC Analytical and Formulation Development, Biologics Consulting
2:40pm - 3:40pm60 minsFocus Forum
External Manufacturing & CDMO Partnerships
ROUNDTABLE SESSION: Navigating the CDMO Selection Maze: Peer Insights and Practical Solutions
- Harsh Chauhan - Director, Formulation Development and External Manufacturing, Alltrna Inc.
3:10pm - 3:40pm30 mins
Downstream Processing
Aggregates PoC: Adaptive automated cation exchange pooling based on real-time process analytical technology (PAT) monitoring for aggregates
- Moira Lynch - Director, Innovation, Thermo Fisher Scientific
3:10pm - 3:40pm30 mins
Analytical, Quality and Characterization
Fireside Chat: Selecting and Applying Next-Generation Analytical Technologies: A Modality-Specific Approach
- Rosalind Ang - Associate Principal Scientist - Biologics & Analytical Research & Development, Merck (pending final confirmation)
3:10pm - 3:40pm30 mins
Development of Emerging Cell & Gene Therapies
Panel Discussion: Harnessing AI & Digitalization for Cell and Gene Therapy Manufacturing - Unlocking Efficiency, Control and Scalability
- Kat Kozyrytska - Managing Director, Kozyrytska Consulting
3:10pm - 3:40pm30 mins
Cell Therapy Manufacturing & Analytics
Panel Discussion: Harnessing AI & Digitalization for Cell and Gene Therapy Manufacturing - Unlocking Efficiency, Control and Scalability
- Kat Kozyrytska - Managing Director, Kozyrytska Consulting
3:10pm - 3:40pm30 mins
Gene Therapy Manufacturing & Analytics
Panel Discussion: Harnessing AI & Digitalization for Cell and Gene Therapy Manufacturing - Unlocking Efficiency, Control and Scalability
- Kat Kozyrytska - Managing Director, Kozyrytska Consulting
3:10pm - 3:40pm30 minsFocus Forum
Drug Product Formulation And Fill Finish
One-step to success: Developing patient self-dosing subcutaneous combination product for biologics using integrated approach
- Yu (Eunice) Tang - Executive Director, PharmDev and Manufacturing, Syndax Pharmaceuticals, Inc
3:40pm - 3:45pm5 mins
BPI Keynote Plenary
Chairperson Opening Remarks
3:45pm - 4:20pm35 mins
BPI Keynote Plenary
PLENARY KEYNOTE: Cancer Drug Production In Space- What are the benefits and the reality?
- Katie King, PhD - CEO & Co-Founder, BioOrbit
4:20pm - 4:55pm35 mins
BPI Keynote Plenary
PLENARY KEYNOTE: The Potential of Human Monoclonal IgE Antibodies to Establish Biological Potency and Stability of Allergen Extracts
- Ronald Rabin - Chief, Laboratory of Immunobiochemistry, CBER, FDA
4:55pm - 5:00pm5 mins
Break
Close of Conference
* 活动内容有可能不事先告知作更动及调整。
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