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

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

Amsterdam, The Netherlands

Course No 9299

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Speakers

Annick Gervais, UCB Pharma, Belgium
Siegfried Giess, Paul Ehrlich Institut, Germany
Holger Kavermann, Roche Diagnostics, Germany
Tim O’Mahony, Janssen Pharmaceutical, Ireland
Daniel Müller, GMP Inspectorate, Germany
Paul Stockbridge, Biopharm Consulting, UK

Objectives

This pre-conference session highlights the key aspects of GMP compliant manufacture of biotechnologically derived APIs. You will get to know the key requirements of the revised Annex 15.

For example you will learn:
what a GMP inspector expects from a GMP compliant manufacturing site
how microbial control strategies can be implemented in cell culture and downstream processing
which key points should be considered when developing analytical test procedures
what the revised Annex 15 requires for cleaning procedures and their validation

Moreover you will get to know the key aspects of the European Biosimilar approach.
This pre-conference session ideally complements the following 18th APIC/CEFIC European Conference on Active Pharmaceutical Ingredients.

Target Group

This pre-conference session is designed for all persons involved in the manufacture of biotechnologically derived APIs especially for persons from production, quality control, quality assurance and control, technical and regulatory affairs departments. We are also addressing interested parties from the pharmaceutical industry and GMP inspectorate

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

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