Cambridge Healthtech Institute’s Inaugural

Analytical Support for Drug Product Development
( 药物开发的分析面支持 )

Overcoming the Analytical and Formulation Challenges of a New Generation of Drug Products



Advances in protein science, drug combinations, delivery technology and analytical methods are supporting an unprecedented wave in novelty in the design of biologic drug products. With these new products comes the urgent need for analytical support of product development, regulatory filings and manufacturing – in ways that require a constant adaptation by analytical and formulation groups to new modalities and technologies. New for 2019, the PEGS Analytical Support for Drug Product Development provides a best practices exchange for scientists now working to develop these new products – or for those wishing to be prepared for forthcoming programs in their organization’s pipelines.


Coverage will include, but is not limited to:


Accelerating DP Development

  • Best practices for shortening the analytical timeline
  • Matching analytical and formulation steps to the TPP and development timeline
  • Platforming analytical and formulation methods; when to deviate from the platform

Comparability Testing

  • Introduction to comparability testing, clinical stages, manufacturing sites, process/product changes
  • Case studies of method bridging
  • Statistical analysis in comparability studies

DP Development for Emerging Product Formats

  • Drug combinations, mixtures, co-formulated products, co-administered products
  • Personalized therapeutics, cell and gene therapies
  • Handling of brand new molecular and product formats

Key Assays and Issues in DP Development

  • Phase appropriate potency assays (binding, cell-based, SPR)
  • Product specific HCP assays
  • Stability challenges of DS, DP and frozen bulk

Delivery and Packaging

  • Update on trends in patient-convenient delivery; analytical and formulation impacts
  • Depot delivery and sustained release formulations
  • Case studies of lifecycle challenges related to delivery and packaging 

Quality and Process Control

  • Development of process and product understanding, design space, CPPs
  • Realtime, in-line process analytics
  • QbD and PAT concepts that can be applied in small companies


* 活动内容有可能不事先告知作更动及调整。


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