Bioanalytical and Formulation Summit
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?