Bioanalytical and Formulation Summit

Event Details

Start Date
Tue, 12 Sept 2017 10:00
End Date
Wed, 13 Sept 2017 19:00
Clarion Congress Hotel, Prague
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Immerse yourself in analytical method development for higher order structures, CQA’s, post translational modifications, aggregation, formulation and stability testing.

Characterisation strategies for improved quality control and analytical development

  • What predictive tools can be used to determine developability of novel therapeutics?
  • Which methods are best for evaluating CQA’s?
  • Is MS the best method for characterisation?
  • How does CRISPR play a part in aggregation and characterisation?
  • Which novel methods are being developed for looking at higher order structure?
  • What are the current trends surrounding multi attribute method analytics?

Optimise approaches for stability testing and AMDVT

  • Appropriate approaches to identify the critical parameters for the safety and efficacy of the biosmilars?
  • What is the best method to use forced degradation studies when demonstrating formulation limits?
  • Which phase appropriate method qualification strategies should you use?
  • What drives the PK and stability with regards to structural characterisation?
  • How best to save time and resources to demonstrate method performance attributes?