Cambridge Healthtech Institute’s 5th Annual

Optimizing Bioassays for Biologics
( 优化生物制剂生物化验 )

Case Studies Demonstrating Successful Bioassay Development



As the bioassay field continues to move forward, challenges are evolving from new drug formats such as antibody therapies, cell therapy and gene therapy. There are numerous considerations to keep in mind during assay development such as lifecycle management and planning for lot release. At the Fifth Annual Optimizing Bioassays for Biologics, bioassay experts will address the top challenges in bioassay design including novel technologies, increasing complex mechanisms-of-action, regulation and the application of statistics in assay development. Case studies and best practices for handling the most common issues in biological assay design will be presented. Overall, this event will showcase ways to continue moving a biologic forward in the discovery pipeline.


Coverage will include, but is not limited to:


  • New bioassay technologies to increase speed and sensitivity
  • Considerations for different formats
    • Antibodies
    • Cell therapy and gene therapy
  • Lifecycle management of biologics
  • Bioassays for quality control, lot management, and release
  • Innovative Bioassay design
    • Design of experiments
    • Automated vs manual bioassays
    • Robotics in bioassays
    • Multi-targeted bioassays
  • Bioassays to unlock a drug’s mechanism-of-action
  • Advanced statistical models for bioassay development and optimization
  • Setting equivalence bounds for similarity
  • Regulator input: USP guidelines and FDA 

* 活动内容有可能不事先告知作更动及调整。

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