GMP-compliant Manufacture of Biotech APIs – an Update - A Pre-conference session to the 18th APIC/CEFIC European Conference

Programme

Regulatory expectations on GMP-compliant manufacture of Biopharmaceuticals
Relevant guidelines for the Biotech industry
New requirements of the revised Annex 2
Regulatory expectations on
Quality management and personnel
Premises and equipment
production
storage and transport
Inspections in biopharmaceutical manufacturing sites
Common issues and examples of observations

Process Validation in the manufacture of Biotech APIs
Regulatory requirements in the EU and US
The new EU/EMA Approach on Process Validation
Requirements of the revised Annex 15
Key principles of the FDA Guidance on Process Validation
Validation approaches and how to apply the principles of ICH Q8, Q9, Q10 and Q11
Continuous process verification and life-cycle approach

Microbial control strategy for cell culture and downstream processing
Applicable sampling regimes
Sample sizes
Methods and method qualification approaches
Inhibitors, hold times and spiking sources
Approach to specifications, action limits, alert limits


How to apply the principles of the FDA Guidance on Method Validation to Biopharmaceuticals – Case Studies
Method development overall strategy
Method development for release and stability testing
Robustness studies
Typical Non-Compendial Methods for Release & Stability of Monoclonal Antibodies
Relative quantitative methods
Control Charts as Continuous Method Performance Verification

New aspects of cleaning validation – how to implement the requirements of the revised Annex 15
Identification of cleaning mechanisms and selection of cleaning agents
Selection of analytical methods for the detection of residues
Establishment of limits in fermentation and downstream processing
Grouping strategies
Final rinse versus swab testing

Quality aspects of the European Biosimilar approach
European regulatory guidance
Generics vs. biosimilars
Biosimilar product and manufacturing process
Comparability exercise