- What is a potency assay?
- Product analytics versus Bioanalytics (preclinical & clinical approach)
- Why do we need bioassays?
- Characterisation of Biopharmaceuticals & Biosimilars
Regulatory Expectations and Requirements on Bioassays and Bioanalytical Methods
- Introduction and general aspects
- Bioassays and methods – expected data
- Guidance documents
GMP & G(C)(L)P Guidelines (EMA & FDA)
- Overview and Interpretation
Development of Bioactivity / Potency Assays – selecting Methods and Types of Assays
- Assay Types
- Feasibility
- Preparing the Cell Bank
- Optimization Parameters
- Replacement methods for primary assays
- Readouts
Development of Immunoassays for GCLP Bioanalytics
- Standards and controls
- Eliminating edge and hook effects
- Setting system suitability criteria
Strategies and Techniques to Improve Assays
- Improve accuracy and repeatability
- Avoid common technical errors
Statistical Analyses & Trending
Development of clinical Assays (PK/PD/ADA)
GMP Validation of Bioactivity (Potency) Assays
- Guidelines and Requirements
- Validation Parameters
- Setting Realistic Sample Specs for Validation
- Phase Specific Validation
- Validation Report
DOE
Case Studies on Special Bioassays for Biopharmaceuticals and Biosimilars
Method Transfer
- How to transfer a method?
- Transfer tools during product development
- Donor and Acceptor
- Investigation, calculation and comparison of method Parameters