Design efficient stability studies that are suitable for global marketing. Be able to carry out appropriate stability studies and manage stability samples and facilities, learning how to save resources on stability testing and improve the likelihood of regulatory approval of stability protocols.
7-8 Jul 2020
& 2-3 Dec 2020
By attending this comprehensive seminar, delegates will learn how to:
Please note that we are delighted to confirm that this course will now also include particulars of the stability of biopharmaceuticals.
Benefits of attending:
Personnel involved in:
Background to stability testing and guidelines
Storage tests, conditions and protocols
Management of stability samples and facilities
Requirements for existing products, line extensions and variations
Data treatment, shelf-life assignment and extrapolation
6 Light stability testing
8 Biopharmaceutical stability
Matrixing and bracketing stability studies
Exercise five (continued)
Ray Munden (7-8 Jul 2020, 2-3 Dec 2020)
Dr Raymond Munden has over 40 years’ experience in pharmaceutical research and development and was formerly Head, Analytical Services Europe for GlaxoSmithKline. He has led project teams that developed many new chemical entities and their pharmaceutical products that were successfully taken to market. Dr Munden has particular expertise in stability protocol design and testing, stability storage facilities, experimental design and degradation chemistry. He is now a consultant for all aspects of pharmaceutical development.
Allan Watkinson (7-8 Jul 2020)
Allan Watkinson, Director of Biopharmaceutical Development CMC, Covance CRS Analytics Ltd.
Allan has many years’ experience in a wide range of CMC activities from process development to biopharmaceutical drug product formulation, and extensive knowledge of protein analytics. As Principal Investigator he has been the technical lead in the development of cold-chain-free thermostable vaccines. Furthermore, he has been instrumental in developing novel analytical techniques for understanding protein structure in particulate biopharmaceutical formulations.
Allan’s main focus now is providing scientific expertise in the biologics analysis and all matters GMP CMC for biopharmaceutical development.
• Biopharmaceutical Analytical development and Technology Transfer
• Biologics Release testing
• Stability testing (including developability, accelerated and forced degradation studies)
• Biotechnology process development cGMP manufacturing
• Biopharmaceutical formulation and biologics stabilisation