This site is part of the Informa Connect Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 3099067.

Well Characterized Biologics & Biological Assays
Mark Your Calendar to Join Us This Year September 23-26, 2024
Hynes Convention Center in BostonBoston, MA
Mark Your Calendar to Join Us This Year September 23-26, 2024|Hynes Convention Center in Boston, Boston, MA


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.

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.


Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your sales and marketing goals. Contact us today at to discuss.

Brian Peterson, MSc.

President, Analytical Consulting

Bioassay Solutions LLC

“The Well Characterized Biologics and Biological Assays conference has a long history of attracting scientists and regulatory professionals with a profound interest in developing best practices for analytical strategies. The opportunities to attend talks, focused short courses, and networking sessions, are second only to the experience of discussion and debate with the highest caliber of professionals in the Industry.”