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Agenda March 18, 2027: Main Conference Day Two - PT (Pacific Time, GMT-08:00)
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Agenda March 18, 2027: Main Conference Day Two - PT (Pacific Time, GMT-08:00)
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Showing 1 of 1 Streams
Registration
8:30am - 8:55am
Registration and Morning Coffee
Showing 5 of 5 Streams
Cell Line Development & Engineering
Cell Culture & Upstream Processing
Downstream Processing
Accelerating Speed from Early Stage Development Through Commercial Manufacturing
Next-Gen Modality, Cell Therapy, and Gene Therapy Development & Production
8:55am - 9:00am
Chairperson's Opening Remarks
9:00am - 9:30am
End-to-End Automation of Cell Line Development: From Workflow Integration to Streamlined Execution
- Lee Peters, Ph.D. - Process Development Senior Scientist, Amgen
9:30am - 10:00am
Scientific Case Study
- Zhenqiu Huang, Ph.D. - Senior Scientist, Merck & Co., Inc.
10:00am - 10:30am
Scientific Case Study
- Yashas Rajendra Ph.D. - Director & Principal Scientist, Denali Therapeutics
8:55am - 9:00am
Chairperson's Opening Remarks
9:00am - 9:30am
Implementing a Lower-Cost Resin in a Licensed Process: A CMC Case Study
- Prasad Pathange, Ph.D. - Director, CMC Process Development & Commercialization, Bayer U.S.
9:30am - 10:00am
Scientific Case Study
- Alois Jungbauer - Professor, Dept. of Biotechnology, BOKU University (BOKU)
10:00am - 10:30am
Shared Panel Discussion: How can Bioprocess Engineering Reduce Manufacturing Costs?
- Irina Ramos, Ph.D - Senior Director, Johnson & Johnson Innovative Medicine
- Alois Jungbauer - Professor, Dept. of Biotechnology, BOKU University (BOKU)
8:55am - 9:00am
Chairperson's Opening Remarks
9:00am - 9:30am
Implementing a Lower-Cost Resin in a Licensed Process: A CMC Case Study
- Apply bioprocess engineering and process understanding to enable a lower-cost resin substitution without fundamentally changing the licensed process or product characteristics.
- Use qualified small-scale models and a risk-based CMC strategy to streamline comparability, qualification, and validation.
- Achieve successful commercial scale PPQ while maintaining process robustness, product quality, and supply continuity.
- Prasad Pathange, Ph.D. - Director, CMC Process Development & Commercialization, Bayer U.S.
9:30am - 10:00am
Scientific Case Study
- Alois Jungbauer - Professor, Dept. of Biotechnology, BOKU University (BOKU)
10:00am - 10:30am
Shared Panel Discussion: How can Bioprocess Engineering Reduce Manufacturing Costs?
- Irina Ramos, Ph.D - Senior Director, Johnson & Johnson Innovative Medicine
- Alois Jungbauer - Professor, Dept. of Biotechnology, BOKU University (BOKU)
8:55am - 9:00am
Chairperson's Opening Remarks
9:00am - 9:30am
Keynote Address: Are We Here Yet? A Digital Maturity Model for Enabling Process Monitoring and Artificial Intelligence in Biologics Manufacturing
- Jack Prior - Head of Process Monitoring & Data Science/AI Strategy, Sanofi
9:30am - 10:00am
Need of Holistic Control Strategies
- Christoph Herwig, Ph.D. - Former Professor of Biochemical Engineering, TU Wien. Serial entrepreneur, CEO Lisalis and Fermify, Lisalis
10:00am - 10:30am
Panel Discussion: Internal vs. External Execution - How to Move Faster With CDMOs and Partner Networks
8:55am - 9:00am
Chairperson's Opening Remarks
9:00am - 9:30am
Accelerating mRNA Vaccine Development with a Cell-Free DNA Template Platform
- Kaiyue Wu - Senior Scientist, Sanofi
10:00am - 10:30am
Panel Discussion: Supply Chain, Data Governance, and the End-to-End Value Chain for Advanced Therapies
- Mukunda Krishna - Associate Director, External Manufacturing, Tech Ops and Supply Chain, Arcturus Therapeutics
Showing 1 of 1 Streams
Networking Break
10:30am - 11:15am
Morning Networking Break in Exhibit Hall
Showing 5 of 5 Streams
Cell Line Development & Engineering
Cell Culture & Upstream Processing
Downstream Processing
Accelerating Speed from Early Stage Development Through Commercial Manufacturing
Next-Gen Modality, Cell Therapy, and Gene Therapy Development & Production
11:15am - 11:45am
Shared Session: AMBR Based Harvest PAR Models
- Megan Cormace - Associate Manager, Process Sciences, Regeneron
- Mahlon Schaffer - Senior Scientist, Process Characterization and Technology, Regeneron
11:45am - 12:15pm
Shared Session: AAV upstream Development Through an Automated, High-Throughput Ambr250 Scale- Down Platform
- Paniz Hadjian - Engineer I, Upstream Process Development, Astellas Pharma
12:15pm - 12:45pm
Scientific Track Presentation
11:15am - 11:45am
From Seed Train to Harvest: Scaling Down Process Characterization with the AMBR250
- Megan Cormace - Associate Manager, Process Sciences, Regeneron
- Mahlon Schaffer - Senior Scientist, Process Characterization and Technology, Regeneron
11:45am - 12:15pm
Shared Session: AAV upstream Development Through an Automated, High-Throughput Ambr250 Scale- Down Platform
- Paniz Hadjian - Engineer I, Upstream Process Development, Astellas Pharma
11:15am - 11:45am
Breaking the Column Bottleneck: Accelerating Antibody Development from Molecule to Clinical Supply
- Sun Chau Siu, Ph.D. - Executive Director, Head of Regulatory Affairs and Project Management, Altruist Biologics
11:45am - 12:15pm
High Throughput Purification Automation Using Resin Slurry for Supplier Change Notifications
- Ellie McGhee - Process Characterization and Technology Engineer, Regeneron
- Cassidy Sheehan - Process Characterization and Technology Engineer, Regeneron
12:15pm - 12:45pm
Scientific Track Presentation
11:15am - 11:45am
PAT Solutions for CQAs
- Jan Schoning - Vice President, Drug Product Biologicals, Boehringer Ingelheim
11:45am - 12:15pm
Biotechnology Readiness Levels(BRL)
- Jeffrey Baker - Senior Fellow, NIIMBL; Strategic Advisor, CBI-MIT, ex-Deputy Director, Office of Biotechnology Product, CDER, FDAs
11:15am - 11:45am
Considerations for Proper Potency Method Development for Conjugated Therapeutics
- Maroun Beyrouthy, Ph.D. - Senior Advisor, Eli Lilly and Company
11:45am - 12:15pm
Integrated Mass Spectrometry and Molecular Modeling Reveal Off-Target Tyrosine Conjugation in a Sulfonylpyrimidine-Based ADC
- Zhengqi Zhang - Senior Scientist, Merck
12:15pm - 12:45pm
Scientific Track Presentation
Showing 1 of 1 Streams
Networking Break
12:45pm - 2:00pm
Luncheon in Exhibit Hall
Showing 5 of 5 Streams
Cell Line Development & Engineering
Cell Culture & Upstream Processing
Downstream Processing
Accelerating Speed from Early Stage Development Through Commercial Manufacturing
Next-Gen Modality, Cell Therapy, and Gene Therapy Development & Production
2:00pm - 2:30pm
Accelerating RPE Electroporation Optimization Through Design of Experiments
- Accelerated: DOE-driven optimization enabled parameter screening 5× faster while reducing material costs by 78%.
- Robust: Optimized conditions support reliable high-throughput Gene-of-Interest (GOI) candidate screening and cross-team technology transfer.
- Scalable: Optimized parameters provide a reproducible foundation for process scale-up and manufacturing development.
- Wanzhu Zhao - Scientist I, Astellas Pharma Inc.
2:30pm - 3:00pm
Intelligent AAV Cell Line Development: AI-Powered Automation and Rapid Screening
- Amit Mathur, Ph.D. - Principal Scientist, Sanofi
3:00pm - 3:30pm
Scientific Track Presentation
2:00pm - 2:30pm
Root-Cause Investigation of Protein A Ligand Leaching on Aged MabSelect SuRe Resin
- Sisi Zhang, MSc. - Principal Scientist, Analytical and Biological Mass Spectrometry, Regeneron
2:30pm - 3:00pm
High-throughput Characterization of Empty/Full AAV Separation for Tech Transfer Support
- Sobhana Sripada - Senior Engineer, Process Development and Clinical Supply, Alexion Pharmaceuticals
3:00pm - 3:30pm
Scientific Track Presentation
2:00pm - 2:30pm
Using Modeling and Simulation, Together with Prior Knowledge, to Accelerate Late-Stage Process Development
- David Garcia Munzer - Director Scientific Office DSD, Novartis
2:30pm - 3:00pm
Scientific Case Study
- Julie Beaudet - Senior Staff Scientist, CMC Regulatory Sciences, Regeneron
2:00pm - 2:30pm
Beyond Ex Vivo CAR-T: Designing Lentiviral Vector Manufacturing for In Vivo Cell Therapy
- Jinlin Jiang, Ph.D. - Director, AstraZeneca
2:30pm - 3:00pm
Scientific Case Study
- Mukesh Mayani - Senior Director, Ultragenyx
3:00pm - 3:30pm
Scientific Track Presentation
Showing 1 of 1 Streams
Networking Break
3:30pm - 4:15pm
Networking Refreshment Break in Poster/Exhibit Hall
Showing 5 of 5 Streams
Cell Line Development & Engineering
Cell Culture & Upstream Processing
Downstream Processing
Accelerating Speed from Early Stage Development Through Commercial Manufacturing
Next-Gen Modality, Cell Therapy, and Gene Therapy Development & Production
4:15pm - 4:45pm
Mastering Four-Chain Balance: Vector Engineering Strategies for High-Performance Bispecific Antibody Expression in CHO Cells
- Four-chain expression balance is a critical determinant of bispecific antibody manufacturability and development success.
- Rational control of chain stoichiometry can substantially improve product quality, assembly fidelity, and production efficiency.
- A systematic framework for balancing chain expression can accelerate cell line development and reduce downstream manufacturing risk.
- Sanjay Ranjit, Ph.D. - Senior Scientist, Takeda Pharmaceuticals Company Limited
4:45pm - 5:15pm
Scientific Case Study
- Zorica Dragic, Ph.D. - Unit Head Cell Line Screening and Development, Novartis
4:15pm - 4:45pm
Scientific Case Study
- Chadakarn Sirasittichoke - Principal Data Scientist, Bristol Myers Squibb
4:45pm - 5:15pm
Panel Discussion: How Far Can Platform Development Really Go? A Cross-Track View on Standardization
4:15pm - 4:45pm
A Case Study: Purification of Bi-Specific Antibodies and Fc-fusion Proteins
- Stefano Menegatti - Professor, Chemical and Biomolecular Engineering, NC State University, North Carolina State University
4:45pm - 5:15pm
Split, Switch, and Stitch: Generating Multispecific Antibodies Using Column Based Redox Reactions
This talk explores the purification of increasingly complex multispecific biotherapeutics. Purification scientists face challenges in finding scalable, efficient methods as therapies advance. Capture redox adds a powerful technique to the purification toolkit, enabling the generation of multispecific antibodies through electro-steering heterodimerization during affinity chromatography—streamlining production and supporting the next generation of innovative medicines.
- Verzhiniya Aho - Senior Scientist, Pfizer
4:15pm - 4:45pm
Scientific Case Study
- Callum Chapman - Executive Director, Product Quality, Gilead
4:15pm - 4:45pm
Scientific Case Study
- MarkVic Naniong - Head of CMC, Kiragen Bio
4:45pm - 5:15pm
From Innovation to the Clinic: Navigating the Challenges of Platform Manufacturing for Arenavirus-Based Cancer Immunotherapies
- Dethardt Müeller, Ph.D. - Chief Technology Officer, CMC, Abalos Therapeutics GmbH
5:15pm - 5:20pm
Close of Conference - See you next year!
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