Advanced CMC Analytical, Comparability and Stability Studies for Biotechnology and Biosimilar Products 2014

Topics

• 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

Who should Attend

• 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