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Well Characterized Biologics & Biological Assays
Now part of BioProcess International!
September 18-21, 2023Boston Convention and Exhibition Center

Now part of BioProcess International!|September 18-21, 2023, Boston Convention and Exhibition Center


Gain Practical Advice From Case Studies, FDA & Regulatory Leaders to Accelerate Your Biologics, Novel Modalities, and Cell & Gene Therapies to Market

WCB 2023 is Now Part of BioProcess International!

This year's event will be co-located as part of the BioProcess International Conference & Exhibition, held September 18-21, 2023 in Boston. This exciting co-location means that you'll still have a dedicated conference for WCB focused on FDA and regulatory guidance to ensure CMC success, while also having access to 2700+ bioprocessing professionals, 200+ exhibitors and 200+ scientific presentations across 7 additional tracks in the BioProcess International agenda.

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.

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 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

Biological Assays Topics

  • 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

Connect With Today's Leading Regulatory, CMC and Bioassay Scientists

Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us as an event sponsor or exhibitor to reach your goals.   

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.”