Mark Your Calendar to Join Us Next Year September 23-26, 2024|Hynes Convention Center in Boston, Boston, MA
THE LEADING EVENT TO ENSURE CMC, REGULATORY SUCCESS AND EXPEDITED PRODUCT APPROVAL
Gain Practical Advice From Case Studies, FDA & Regulatory Leaders to Accelerate Your Biologics, Novel Modalities, and Cell & Gene Therapies to Market
Thank You to the 3000+ Attendees of BioProcess International 2023!
This year's event was the largest in event history, gathering 3000+ attendees and 260+ exhibitors representing 40 countries around the world. Mark your calendar to join us at next year's event, held September 23-26, 2024 at the Hynes Convention Center in Boston. Sign up for email updates below for the latest news on BPI 2024 events.
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See Our Keynote Speaker Lineup for This Years Event!
Learn how to apply today's leading strategies to ensure CMC, regulatory success and expedited product approval directly from leading FDA regulators & industry experts.
Accelerate your product timelines and overcome development and submission challenges
This year’s program will showcase regulatory officials, academic and industry experts sharing their perspectives, new data and case studies on applying innovative strategies and technologies to ensure CMC, regulatory success and expedited product approval. Together with a world-class advisory committee, we have develop an agenda that reflects the leading trends and approaches to overcome development and submission challenges, including:
Well Characterized Biologics & Biological Assays Topics
- Emerging Trends in Characterization of Impurity and Degradant Peaks
- Standards for Analytical Methods
- Implementing Total Analytical Control Strategies
- How to Properly Leverage Platform Technologies and Prior Knowledge for Successful QbD and Regulatory Approaches
- Biological Assay Development
- Biological Assays for Novel Modalities
- Strategies for Accelerated Characterization, Method Development, and Method Transfers
- Phase Appropriate Method Validation (Include Coverage of ICH Q2 and ICH Q14)
- Analytical Challenges and Considerations for Formulations and Drug Product
- Analytical and Regulatory Strategies for Biosimilars
- Regulatory Perspectives on Emerging Trends, Global Harmonization, Interacting with FDA and Accelerated Pathway Designations
- Regulatory Perspectives for Cell and Gene Therapies
- Analytical strategies, CMC Approaches and Analytical Tools for Modern Vaccines, LNPs and Well Characterized Gene Therapies
Analytical & Quality Topics
- Advances in HTPD, Automation, and PAT that are Transforming the Bioprocessing Industry
- Utilizing Mass Spectroscopy and Raman Spectroscopy in Process Development
- Implementing Total Analytical Control Strategies
- Advanced Analytics that Enable Continuous Processing
- Achieving Real-Time Monitoring and Release
- Risk Assessments for Maintaining Process & Product Quality Standards for Analytical Methods
- Phase Appropriate Analytical Testing to Streamline the Product to Market New Multi-Attribute Methods Being Implemented in a QC Environment
- Emerging Analytics for Host Cell Proteins
- Analytical Methods for Novel Modalities and Biosimilars
- Implementing Analytical Lifecycle Management Strategies
Thank You to our Scientific Advisory Committee
Syama Adhibhatta, Ph.D., Senior Director, Quality Analytics, Vertex Pharmaceuticals
Neeraj Agrawal, Ph.D., Director, Amgen
Jeff Baker, Ph.D., Senior Fellow, NIIMBL; Strategic Advisor, CBI-MIT
Kimberly Benton, Master Principal, Dark Horse Consulting Group
Darryl Davis, Ph.D., Senior Director, AstraZeneca
Patrick Gammell, Vice President, Global Manufacturing Sciences, Biogen
Don Kerkow, Ph.D., Vice President, Analytical & Formulation Sciences, KBI Biopharma
Stephen Krause, PhD, Executive Director, Analytical Science and Technology, Cell Therapy Quality, Bristol Myers Squib
Elisabeth Krug, BRD Analytical Development, Eli Lilly and Company
Amit Kundu, Ph.D., Director of Manufacturing Sciences, Takeda
Nadine Ritter, Ph.D., President and Analytical Advisor, Global Biotech Experts, LLC
Yuval Shimoni, Associate Director, Product Quality Leader, BioMarin Pharmaceutical
Johnson Varghese, Head of Analytical Sciences & Development, Beam Therapeutics
Yi Yang, Ph.D., Senior Scientist, Protein Chemistry Group, Genentech Inc.
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