SC 3 - Accelerated Stability Testing of Biologics
Monday, August 3
9:00—11:30 am
This short course will aim to guide the researcher in designing studies for accelerated stability testing of biologics. The course will begin with basic underlying concepts governing protein drug product stability, and focus on design principles for measuring stress and accelerated stability testing of not only the protein of interest, but also of excipients and primary packaging components. Strategies to handle complexities arising from their interactions will also be discussed.
- Attributes of a successful protein drug product
- Modes of protein degradation: Conformational stability, colloidal stability and chemical stability
- Chemical degradation reaction
- Real-time/accelerated/stress stability testing: Rational design of stability conditions
- Stressors for evaluating protein stability
- Developing predictive and correlative tools: Utility, desired features and examples
- Excipients
- Primary packaging
- Application of novel tools, DoE and practical insight from case studies for developing robust protein formulations
Instructors:
Jan Jezek, Ph.D., CSO, Development, Arecor Ltd.
Jan Jezek, the principal inventor of the core protein stabilisation technologies, is a biochemist with a strong background in physical chemistry. Currently responsible for R&D activities, platform development and technical IP support in the field of stabilisation of biologics. He played a crucial role in the development of stabilising technologies for commercially important proteins that allow preservation of protein structure and biological activity during sterilisation by gamma radiation and during long-term storage at ambient temperature. Lead successful grant funded projects with TSB funding. Previously, a Principal Scientist at Insense Limited, he was responsible for development of novel medical devices from concept to market. Dr. Jezek holds a joint Doctorate from the University of Bedfordshire and the University of Chemical technology, Prague. He is a member of the Scientific Advisory Board of the Centre of Excellence in Biopharmaceuticals (University of Manchester). He is also a committee member of the Formulation Science & Technology Group (FSTG) at the Royal Society of Chemistry.
Sanket Patke, Ph.D., Research Investigator, Drug Product Science and Technology, Pharmaceutical Development, Bristol-Myers Squibb
Dr. Sanket Patke is a Research Investigator at the Drug Product Science and Technology (Pharmaceutical Development) group at Bristol-Myers Squibb Co. Since joining BMS in 2014, Sanket has been involved in formulation development activities for several biologic molecules, including monoclonal antibodies, fusion proteins, PEGylated proteins etc. He is also responsible for developing clinical and commercial formulations, supporting manufacturing and technology transfer, and providing support for toxicology and clinical studies. His expertise lies in the area of early and late stage formulations, protein colloidal stability, and protein physical and chemical degradation. Sanket completed his PhD in chemical engineering from Rensselaer Polytechnic Institute, Troy, NY and undergraduate studies in chemical engineering from University Institute of Chemical Technology, Mumbai, India. He has authored 7 peer reviewed papers, is a reviewer for several scientific journals, and serves as an advisory board member for several national and international conferences.