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Bioanalytical technologies and strategies to reduce timelines, increase product quality and meet regulatory requirements

Apply practical case studies from global experts working across protein characterisation, AMDVT, formulation, CMC and bioassay development

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IMPROVE CHARACTERISATION ACROSS ALL PHASES OF BIOLOGICS DEVELOPMENT AND PRODUCTION

For 2019, the Bioanalytical and Formulation Summit will run as a 3-day stream as part of BioProduction, part of CPhI worldwide.  Key topics covered as part of the Bioanalytical stream are listed below.

Bioanalytical Method Development, Validation, and Transfer
  • Explore industry approaches to analytical strategies
  • Create more efficient workflows by completing a much as possible earlier in development
  • Refine analytical method validation and qualification
Protein Characterisation
  • Understand Critical Quality Attributes and Post Translational Modifications and how to measure them
  • Develop methods for analysing novel biologic formats
  • Apply new technologies and orthogonal methods to protein characterisation
Bioassay
  • Accelerate bioassay timelines by applying phase appropriate potency assay strategies
  • Improve product quality by analysing impurities and testing immunogenicity
  • Gain insight into bioassay approaches for complex cell therapies
Formulation and Stability Testing for Biopharmaceuticals
  • Latest advances and techniques in predicting the stability of biologics
  • Learn to balance dosage and potency for formulation development
  • Discuss the relationship between formulation, immunogenicity and impurities when producing biologics