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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

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

Part of BioProcess International

Well Characterized Biologics & Biological Assays is a track at BioProcess International (BPI) that allows you to gain practical advice from case studies, FDA & regulatory leaders to accelerate your biologics & novel modalities/molecules to market.

Buying a pass to this track allows you access to BPI's other tracks: Cell Line Development & Engineering, Development of Emerging CGTs, Cell Culture & Upstream Processing, Recovery & Purification, Analytical & Quality, Manufacturing Strategy & Bioprocessing 4.0, Cell Therapy Manufacturing, and Gene Therapy Manufacturing.

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 

CONNECT WITH KEY BUYERS BY BECOMING A BPI SPONSOR/EXHIBITOR

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 Partners@informaconnectls.com 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.”