September 15 -18, 2025
Hynes Convention CenterBoston, USA
Key Sessions
The Future of Biopharmaceutical Manufacturing: Innovation and Collaboration
Wednesday 17th September - Main Conference Day Two - ET (Eastern Time, GMT-05:00)
Wednesday 17th September - Main Conference Day Two - ET (Eastern Time, GMT-05:00)
8:00am - 9:00am60 mins
Registration and Morning Coffee
9:00am - 9:10am10 mins
Keynote Plenary
Welcome to BWB Day 2 / Chairperson's Opening Remarks
9:00am - 9:05am5 mins
Development of Emerging Cell & Gene Therapies
Chairperson's Opening Remarks: Development of Emerging Cell & Gene Therapies
- Mahesh Bule - Associate Director, Kite Pharma a Gilead Company
9:00am - 9:05am5 mins
Cell Therapy Manufacturing & Analytics
Chairperson's Opening Remarks: Cell Therapy Manufacturing & Analytics
9:00am - 9:05am5 mins
Gene Therapy Manufacturing & Analytics
Chairperson's Opening Remarks: Gene Therapy Manufacturing & Analytics
9:05am - 9:35am30 mins
Development of Emerging Cell & Gene Therapies
Harnessing AI and Machine Learning for the Future of Cell & Gene Therapy Development
9:05am - 9:35am30 mins
Cell Therapy Manufacturing & Analytics
Scaling Out Cell Therapy Manufacturing: Smarter, Faster, and More Affordable
- Amy Shaw - Head of Process and Product Development, Takeda, USA
9:05am - 9:35am30 mins
Gene Therapy Manufacturing & Analytics
Strategies for Scaling Up, Accelerating and Commercializing Gene Therapy Manufacturing
- Ying Cai - MSAT Executive Director, Ultragenyx Pharmaceutical
9:10am - 9:50am40 mins
Keynote Plenary
BPI Keynote 3
9:35am - 10:05am30 mins
Development of Emerging Cell & Gene Therapies
Redosable DNA Delivery Systems Designed by Machine Learning
- Shashi Murthy, PhD - CTO and Co-Founder, Nanite Inc.
9:35am - 10:05am30 mins
Cell Therapy Manufacturing & Analytics
Scaling Out Cell Therapy Manufacturing
- Mark Farmery - Chief Development Officer, Anocca AB
9:35am - 10:05am30 mins
Gene Therapy Manufacturing & Analytics
Case Study on Tech Transfer and Scale Up – How to Translate from Small to Large Scale / GMP
- Phillip Ramsey - Senior Vice President, Technical Operations, Sangamo Therapeutics
9:50am - 10:30am40 mins
Keynote Plenary
BPI Keynote 4
10:05am - 10:30am25 mins
Development of Emerging Cell & Gene Therapies
Revolutionizing Targeted Delivery: Emerging Technologies to Enhance Precision & Minimize Off-Target Effects
10:05am - 10:30am25 mins
Cell Therapy Manufacturing & Analytics
Bringing Cell Therapy to the Patient—Implementing Decentralized Manufacturing
10:05am - 10:30am25 mins
Gene Therapy Manufacturing & Analytics
Tech Transfer Best Practices to CMOs
- Jordan Ball - Sr. Manager, Technology Transfer, Regeneron
10:30am - 11:25am55 mins
Morning Break in Exhibit Hall
11:25am - 11:30am5 mins
Cell Line Development & Engineering
Chairperson Remarks: Cell Line Development & Engineering
11:25am - 11:30am5 mins
Cell Culture & Upstream Processing
Chairperson Remarks: Cell Culture & Upstream Processing
11:25am - 11:30am5 mins
Downstream Processing
Chairperson Remarks: Downstream Processing
11:25am - 11:30am5 mins
Manufacturing Strategy & Digitalization
Chairperson Remarks: Manufacturing Strategy & Digitalization
11:25am - 11:30am5 mins
Analytical, Quality and Characterization
Chairperson Remarks: Analytical, Quality and Characterization
11:30am - 12:00pm30 mins
Cell Line Development & Engineering
NGS Applications for Sequence Variant Analysis
- Shu Wang - Principal Investigator, Incyte
11:30am - 12:00pm30 mins
Cell Culture & Upstream Processing
Next-Gen Upstream Lab: Flexible and Scalable AI Deployment with MLOps
- Shu Yang - Senior Scientist, Pfizer
- Edwin Shen - Principal Scientist, Pfizer
11:30am - 12:00pm30 mins
Downstream Processing
The challenge of impurity clearance in a world of complex modalities and high productivities: a case study in low molecular weight (LMW) removal
- Crystal Thomas - Process Engineer III, Sanofi
11:30am - 12:00pm30 mins
Manufacturing Strategy & Digitalization
The Future of Biopharmaceutical Manufacturing: Innovation and Collaboration
11:30am - 12:00pm30 mins
Analytical, Quality and Characterization
Ensuring Product Comparability & Accelerating Analytical Method Development: Bridging Early and Late-Phase Development
11:30am - 12:00pm30 mins
Development of Emerging Cell & Gene Therapies
Leveraging Gene Editing Technologies for Precision and Efficiency in Cell and Gene Therapy Development
- Kristy Wood, PhD - SVP, Technical Operations, Intellia Therapeutics
11:30am - 12:00pm30 mins
Cell Therapy Manufacturing & Analytics
Strategies for Success Implementation of Automation at Scale in Cell Therapy Manufacturing
- Shawn (Xueyuan) Wang - Director, Process Development, Kite Pharma
11:30am - 12:00pm30 mins
Gene Therapy Manufacturing & Analytics
Revolutionizing Large Scale Gene Therapy Production: Boosting Cell Density and Cell Specific Productivity with Advanced Producer Cell Lines
12:00pm - 12:30pm30 mins
Cell Line Development & Engineering
Use NGS to facilitate CHO or HEK293 clone screening to support therapeutic protein or cell therapy pipelines
- Xiaodong Sun - Senior Scientist, Takeda
12:00pm - 12:30pm30 mins
Cell Culture & Upstream Processing
Error Reduction Using Small-Scale Models and Scale-Up Insights
12:00pm - 12:30pm30 mins
Downstream Processing
Harvest Development and Optimization using pDADMAC Flocculation
- Kate Zhao - Scientist I, Upstream Process Development, Alexion, AstraZeneca Rare Disease
12:00pm - 12:30pm30 mins
Manufacturing Strategy & Digitalization
CMC Regulatory Filings for NCE's – How to Develop Module 3 for the FDA and the EU/UK without constraining Development Efforts
- Jack Greene - Chief Technical and Manufacturing Officer, JucaBio
12:00pm - 12:30pm30 mins
Analytical, Quality and Characterization
Defining and Controlling Critical Quality Attributes (CQAs) for Gene and Cell Therapies
- Callum Chapman - Senior Director, Product Quality, Product Quality
12:00pm - 12:30pm30 mins
Development of Emerging Cell & Gene Therapies
Next-Gen Gene Editing – Pushing Boundaries for Enhanced Therapeutics
12:00pm - 12:05pm5 mins
Cell Therapy Manufacturing & Analytics
Scalable and Cost-Effective Pluripotent Stem Cell Expansion: Enabling Commercialization
- Wonjong Si - Associate Director, Cell Therapy Platform Process, Bayer
12:00pm - 12:30pm30 mins
Gene Therapy Manufacturing & Analytics
Expanding the Upstream Toolbox: Enabling High-Productivity, Robust, and Scalable AAV Production
- Huize Yan - Process Development Scientist, Spark Therapeutics
12:05pm - 12:35pm30 mins
Cell Therapy Manufacturing & Analytics
Automating the Future: Enabling Closed-System Cell Therapy Manufacturing
12:30pm - 1:00pm30 mins
Cell Line Development & Engineering
Sponsored Presentation: Establishing a Robust Workflow to Identify High-Performing Clones
12:30pm - 1:00pm30 mins
Cell Culture & Upstream Processing
Sponsored Presentation: Emerging Tools for Real-Time Process Monitoring
12:30pm - 1:00pm30 mins
Downstream Processing
Sponsored Presentation: Novel Approaches in Affinity Chromatography & Process Design
12:30pm - 1:00pm30 mins
Manufacturing Strategy & Digitalization
Sponsored Presentation: Beyond the Playbook: Operational Efficiency in CMC
12:30pm - 1:00pm30 mins
Analytical, Quality and Characterization
Sponsored Presentation: Multi-Omics for Biologics: Deep Dive into Product Quality and Process Understanding
12:30pm - 1:00pm30 mins
Development of Emerging Cell & Gene Therapies
Application of Next Generation Editing Technologies
12:30pm - 1:00pm30 mins
Gene Therapy Manufacturing & Analytics
Next-Gen Innovations: Transforming Upstream Process Development in Gene Therapy
1:00pm - 2:10pm70 mins
Lunch Networking
2:10pm - 2:15pm5 mins
Cell Line Development & Engineering
Chairperson Remarks: Cell Line Development & Engineering
2:10pm - 2:15pm5 mins
Cell Culture & Upstream Processing
Chairperson Remarks: Cell Culture & Upstream Processing
2:10pm - 2:15pm5 mins
Downstream Processing
Chairperson Remarks: Downstream Processing
2:10pm - 2:15pm5 mins
Manufacturing Strategy & Digitalization
Chairperson Remarks: Manufacturing Strategy & Digitalization
2:10pm - 2:15pm5 mins
Analytical, Quality and Characterization
Chairperson Remarks: Analytical, Quality and Characterization
2:10pm - 2:15pm5 mins
Development of Emerging Cell & Gene Therapies
Chairperson's Opening Remarks: Development of Emerging Cell & Gene Therapies
2:10pm - 2:15pm5 mins
Cell Therapy Manufacturing & Analytics
Chairperson's Opening Remarks: Cell Therapy Manufacturing & Analytics
- Shashi Prajapati - Director, Cell & Gene Therapies Analytical Development, Vertex Pharmaceuticals
2:10pm - 2:15pm5 mins
Gene Therapy Manufacturing & Analytics
Chairperson's Opening Remarks: Gene Therapy Manufacturing & Analytics
2:15pm - 2:45pm30 mins
Cell Line Development & Engineering
13 C Metabolic Flux Analysis (MFA) of CHO cells utilizing various media and feed packages to elucidate metabolic bottlenecks
- Lorena Pena - Scientist, Bristol-Myers Squibb
2:15pm - 2:45pm30 mins
Cell Culture & Upstream Processing
This study evaluates the use of capacitance probes in the Sartorius Generation2 ambr250 bioreactors
- Lorraine Peters - Associate Principal Scientist, AstraZeneca
2:15pm - 2:45pm30 mins
Downstream Processing
The requirements of a method for the measurement of aggregate levels during the CEX bind and elute polishing unit operation in the production process of monoclonal antibodies
2:15pm - 2:45pm30 mins
Manufacturing Strategy & Digitalization
CMC in the Age of Personalized Medicine: Meeting the Unique Challenges of Small Batch Manufacturing
- Gregory Zarbis-Papastoitsis, Ph.D - Chief Process and Manufacturing Officer, Ankyra
2:15pm - 2:45pm30 mins
Analytical, Quality and Characterization
Knowledge Management as a Regulatory Priority: Demonstrating Product Consistency and Control
2:15pm - 2:45pm30 mins
Development of Emerging Cell & Gene Therapies
Viral vs. Non-Viral – The Future of In Vivo Delivery Systems
2:15pm - 2:45pm30 mins
Cell Therapy Manufacturing & Analytics
Advanced Analytical Strategies for Cell Therapy Product Characterization
- Lena Yang - Senior Scientist, Cell Therapy Analytical Development, Takeda
2:15pm - 2:45pm30 mins
Gene Therapy Manufacturing & Analytics
Rapid Development of AAV Purification Process Without Sacrificing Recovery
- Hunter Reese - Scientist II, Asklepios Biopharmaceutical
2:45pm - 3:15pm30 mins
Cell Line Development & Engineering
Optimizing Vector Design to Enhance Expression and Quality of Bispecific Antibodies
- Fernanda Sobreira - Associate Principal Scientist, Merck
2:45pm - 3:15pm30 mins
Cell Culture & Upstream Processing
Evaluating a high-throughput cell culture system for late-stage process development
2:45pm - 3:15pm30 mins
Downstream Processing
Case Study and Development Overview of Recovery and Downstream Challenges from Harvest to UF/DF for an Antibody in Accelerated Development
2:45pm - 3:15pm30 mins
Manufacturing Strategy & Digitalization
Sustainable Biomanufacturing: Achieving ESG Goals While Meeting Capacity Demands
2:45pm - 3:15pm30 mins
Analytical, Quality and Characterization
The Future of Process Analytical Technology (PAT) and AI-Driven Modeling in Bioprocessing
2:45pm - 3:15pm30 mins
Development of Emerging Cell & Gene Therapies
Optimizing LNP Delivery and Non-Viral Vector Manufacturing as Scalable, Redosable Alternatives to Viral Vectors
2:45pm - 3:15pm30 mins
Cell Therapy Manufacturing & Analytics
Best Practices for Developing Robust Potency Assays for Cell Therapies
- Mariska ter Haak - Senior Director Analytical Development, IN8bio
2:45pm - 3:15pm30 mins
Gene Therapy Manufacturing & Analytics
Maximizing Capsid Recovery: Optimizing Downstream Processing for Higher Yields
- Junfen Ma - Head of Genomic Medicine Purification Process Development, Sanofi
3:15pm - 3:45pm30 mins
Cell Line Development & Engineering
Sponsored Presentation: CLD Strategies Fit For a New Era of Biologic
3:15pm - 3:45pm30 mins
Cell Culture & Upstream Processing
Sponsored Presentation: Managing Shear Stress and Mechanical Forces in Bioreactors For Improved Cell Health and Viability
3:15pm - 3:45pm30 mins
Downstream Processing
Sponsored Presentation: Unlocking Hidden Yields: Maximizing Product Recovery with Purification Technologies
3:15pm - 3:45pm30 mins
Manufacturing Strategy & Digitalization
Sponsored Presentation: Building a Sustainable Future for Biomanufacturing
3:15pm - 3:45pm30 mins
Analytical, Quality and Characterization
Sponsored Presentation: Next-Gen Purification & Real-Time Analytics: Transforming Bioprocessing for Emerging Modalities
3:15pm - 3:45pm30 mins
Development of Emerging Cell & Gene Therapies
Utilizing Next-Gen Delivery Vehicles
3:15pm - 3:45pm30 mins
Cell Therapy Manufacturing & Analytics
Novel Analytical Technologies to Enhance Cell Therapy Product and Process Characterization
3:15pm - 3:45pm30 mins
Gene Therapy Manufacturing & Analytics
Optimizing Gene Therapy Productivity: Cutting-Edge Technology Innovations for Superior Downstream Processing
3:45pm - 4:30pm45 mins
Afternoon Break
4:30pm - 5:00pm30 mins
Cell Line Development & Engineering
Generating and characterizing a comprehensive panel of CHO cells glycosylation mutants for advancing glycobiology and biotechnology research
4:30pm - 5:00pm30 mins
Cell Culture & Upstream Processing
Improving Monomer Purity in Cell Culture Harvests
- Michael Si - Scientist, Sanofi
4:30pm - 5:00pm30 mins
Downstream Processing
Emerging Detection Technologies and ICHQ5A: Closing Gaps in Viral Detection
4:30pm - 5:00pm30 mins
Manufacturing Strategy & Digitalization
Creating a Winning Target Product Profile: A Roadmap for Successful Biopharmaceutical Development
4:30pm - 5:00pm30 mins
Analytical, Quality and Characterization
Streamlining Biologics Testing: Implementing Multi-Attribute Methods from Development to QC
- Hao Zhang - Sr. Principal Scientist, Amgen
4:30pm - 5:30pm60 mins
Development of Emerging Cell & Gene Therapies
Cell and Gene Therapy CDMO Selection and External Manufacturing Best Practices
- Jeff Masten - Senior Vice President CMC, Secretome Therapeutics
- Matthew Provencal - Executive Director Gene Therapy BDS Manufacturing, Sarepta
4:30pm - 5:00pm30 mins
Cell Therapy Manufacturing & Analytics
Strategy for Cell Therapy Potency Assurance
- Dong Xu, Ph.D. - Associate Director, Cell Therapy Analytical Development, TScan Therapeutics
4:30pm - 5:00pm30 mins
Gene Therapy Manufacturing & Analytics
Detectability and Propagation of MVM in HEK293 Cells: What it means for your Viral Safety Strategy
- Dana Schreffler - Sr. Manager QC Viral Safety, Regeneron
5:00pm - 5:30pm30 mins
Cell Line Development & Engineering
Producer Cell Lines: A Paradigm Shift in Viral Vector Manufacturing
5:00pm - 5:30pm30 mins
Cell Culture & Upstream Processing
Fireside Chat: How do we go to the next level for Cell Culture and Upstream Development?
5:00pm - 5:30pm30 mins
Downstream Processing
Future Trends in Bioprocess Filtration: Exploring Novel Technologies and Approaches
5:00pm - 5:30pm30 mins
Manufacturing Strategy & Digitalization
Fireside Chat: Balancing Innovation with Existing Biomanufacturing Systems
5:00pm - 5:30pm30 mins
Analytical, Quality and Characterization
Data-Driven Biomanufacturing: Integrating QC, Process Development, and Manufacturing for Seamless Operations
5:00pm - 5:30pm30 mins
Cell Therapy Manufacturing & Analytics
Robust Process Validation Strategies for Cell Therapies
5:00pm - 5:30pm30 mins
Gene Therapy Manufacturing & Analytics
Mastering hcDNA: A Harmonized CMC Approach in AAV Therapies
- Parag Kumthekar - Gene Therapy Downstream Process Development Lead, UCB Pharma
5:30pm - 7:30pm120 mins
Party
7:30pm - 7:35pm5 mins
Close of Day Two
* 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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