BioProduction

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