Forced Degradation Studies/ Biologics Stability Programs for Biopharmaceuticals (Pharmaceutical Train)
Venue: Online Event
|Event Date/Time: Sep 17, 2010||End Date/Time: Sep 17, 2010|
A well designed Program for Protein Therapeutic Lot Release and Stability, when implemented right from the initial stages of a project will result in Right-first -time CMC data package and therefore lead to cost savings in terms of Analytical Lab and Regulatory Department resource requirements. While retained samples of conventional drugs can be re-tested at later dates by newly implemented methods, such re-testing of WCP samples is usually less successful. A well designed analytical program will therefore minimize the need for repeating costly stability studies as a result of feedback from regulatory agencies.
This course is designed to provide the attendee with an overview of a Forced Degradation study on a Protein Therapeutic, to interpret and leverage the results to design the Stability Studies required for registration of the BLA. The stress conditions typically used to study the tendency of the protein to undergo degradation by pathways such as oxidation, deamidation and fragmentation will be addressed. Analytical methods such as RP-HPLC, IEX, AUC and FFF required to quantitiate and characterize the degradants will be described. Leveraging the Forced Degradation results to design Stability studies for the Drug Substance and Drug Product will be discussed.