Forced Degradation Studies/ Biologics Stability Programs for Biopharmaceuticals
Website https://www.complianceonline.com/forced-degradation-studies-biologics-stability-programs-for-biophar |
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Deadline: July 18, 2018 | Date: July 18, 2018
Venue/Country: online event, U.S.A
Updated: 2018-06-11 14:38:19 (GMT+9)
Call For Papers - CFP
This 90 minute session is designed to provide the attendee with an overview of a forced degradation study on a protein therapeutic and to interpret and leverage the results to design the stability studies required for registration of the BLA. The speaker will address the stress conditions typically used to study the tendency of the protein to undergo degradation along with the analytical methods required for the study. Forced degradation study data must be utilized during the design of the stability program. We will discuss how you can leverage the forced degradation results to design stability studies for the drug substance and drug product. The regulatory requirements for such studies will be addressed.Areas Covered in the Webinar:What is the purpose of a forced degradation study?What are the conditions to be used during well characterized protein forced degradation study?How to test for the degradants?Design of a compliance wcp stability study based on the forced degradation results.How to conduct a biologics stability study?Common mistakes during forced degradation studiesKeywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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