Advanced CMC Analytical, Comparability and Stability Studies for Biotechnology and Biosimilar Products 2014 is a course that covers topics such as:
- Method lifecycle studies including what should go into written procedures for characterisation/comparability methods
- Main elements critical for establishing reliable and meaningful product specifications for biotech and biosimilar products
- Overcome the challenges of devloping and validating process-specific host cell protein assays
- What kinds ofchemical and physical forced degradation studies are applicable to biotech/biosimilar products
- Different types and uses of biotechnology reference standards and materials
- Criticaltechnical aspects of assessing biotechnology product comparability
Advanced CMC Analytical, Comparability and Stability Studies for Biotechnology and Biosimilar Products 2014 is intended for:
- Stability program managers
- QC release and stability analysts
- Process analytical chemists and process development scientists
- Product scientists and test method technical experts (R&D and QC)
- GMP compliance auditors
- Quality assurance specialists
- Analytical and stability laboratory managers (R&D through GMP)
- Regulatory affairs CMC authors or reviewers
- Business managers with CMC responsibilies
- Project managers with CMC responsibilities
- Contract testing labs
- Key staff from biotech academic incubators and small start-ups
