View our webinar recording: ‘Biopharmaceutical Stability Studies’ with guest speaker Dr. Mark Powell.
Biopharmaceutical Stability Studies
Listen to Dr. Mark Powell as he discusses Biopharmaceutical Stability Studies.
Stability is a particular problem for biopharmaceutical products because the physical and chemical stability of peptides and proteins are often very sensitive to storage and transportation conditions. The purpose of this webinar is to explain the typical approach for the design of a stability study for biologics. The webinar also covers the specific challenges of these product types as well as typical degradation mechanisms.
This webinar covers:
- Overview of ICH Q5C – Stability testing of biotechnological/biological products
- Specific stability challenges for biologics
- Protein and peptide degradation pathways
- Evaluating stability – typical tests
- In-use stability
- Stability after reconstitution
About the speaker Dr. Mark Powell
Dr. Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as a Senior Analytical Chemist.
Mark has served as both Honorary Secretary and Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016. He has worked at a senior level in a number of companies with responsibility for analytical development and equipment qualification. In 2010 Mark was appointed Scientific Manager of a UK-based pharmaceutical CRO, with responsibility for guiding the direction of drug development programmes as well as establishing collaborations with academia and instrument manufacturers.
In 2013, he set up his own company to provide training and consultancy services to the pharmaceutical industry. His consultancy work has involved, amongst other things, managing the analytical aspects of pharmaceutical development programmes and conducting data integrity audits. He is in demand as a trainer in topics such as pharmaceutical development, chromatography, spectroscopy, dissolution testing, data integrity, control of impurities, technical writing, stability/stress studies and sample preparation.
To view this webinar, please visit our webinar recording page.