Cambridge Healthtech Institute’s 9th Annual

Characterization of Biotherapeutics
( 生物制剂的表徵分析 )

Exploring the Analytical Challenges of Today’s Complex Biologics



As new product formats progress through development and into the regulatory process, the role of analytical characterization is taking on new meaning. Very new modalities present challenges to both analytical scientists and regulatory agencies alike, and this steep learning curve requires a near-constant cycle of adaptation and innovation.

The agencies are requiring sponsors to provide ever more complex data across a wide range of analytical methods, and instrumentation suppliers are striving to support this new era with unique product features, software and feature combinations. The PEGS Characterization of Biotherapeutics conference explores the progression of analytical development for an exciting range of emerging modalities and offer a case study forum for those working in the field to share ideas, experiences and solutions that support the preclinical and clinical development of new biotherapeutics.

Coverage will include, but is not limited to:


Multivalent Therapeutics

  • Characterization impacts of unique bispecific platforms
  • Characterization challenges of antibody mixtures and combinations
  • Characterization challenges of co-administered and co-formulated products       

ADCs and Conjugated Proteins

  • New methods and technologies for ADC characterization
  • Characterization of other conjugated protein drugs
  • Characterization of small molecule impurities 

Gene Therapy

  • Introduction to gene therapy characterization steps and methods
  • FDA draft guidance on CMC information required in gene therapy IND filings
  • Assay development and validation for viral vector testing and characterization 

CAR-T and Cell Therapy

  • Introduction to cell therapy characterization steps and methods
  • Tools and methods for determining the stability of cell therapies
  • Characterization challenges for CAR-Ts; potency assays, release panel, in-process analytics 

Characterization of Complex Formats and Challenging Targets

  • Neuroscience targets and the BBB
  • Stability testing for non-antibody protein domains
  • In vivo assays for biotherapeutics with extended half lives

Regulatory Challenges

  • The regulatory path for Breakthrough designations and orphan drugs
  • Trends in informal requests from regulatory agencies for additional characterization steps
  • Case studies of the analytical/CMC sections regulatory dialog


* 活动内容有可能不事先告知作更动及调整。

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