Stability of Biopharmaceutical Products

Online Training Id: GMP-008

Geographical Region: Global

Level: Basic

Duration: 2 hrs 30 mins

This eLearning course will outline the requirements for Stability Testing of Biotechnological biological Products biotechnological/biological products and the  distinguishing characteristics to which consideration should be given in any well-defined testing program designed to confirm the stability of Biopharmaceutical products during the intended storage period. Biopharmaceutical products are particularly sensitive to environmental factors such as temperature changes, oxidation, light, ionic content, and shear. In order to ensure maintenance of biological activity and to avoid degradation, stringent conditions for their storage are usually necessary.

Learning Objectives:

This course will provide the methods for the evaluation of stability which may necessitate;

  • Complex analytical methodologies.

  • Assays for biological activity, where applicable, should be part of the pivotal stability studies.

  • Appropriate physico-chemical, biochemical and immunochemical methods for the analysis of the molecular entity and the quantitative detection of degradation products which should also be part of the stability program whenever purity and molecular characteristics of the product permit use of these methodologies.

Author:

 

 

 

Thomas G. (Gary) Bird, Ph.D. is co-founder of PharmaConsult Global, Ltd., an international cooperative supplying GXP quality consulting services and  President, PharmaConsult-US, LLC. He served as Director of Corporate Quality for GTx, Inc. (Memphis, TN, USA) from 2003 until 2013 and was responsible for confirming all non-clinical (GLP), manufacturing (GMP), and clinical trial (GCP) related activities were conducted in compliance with appropriate laws and regulations. 

He developed all Quality Systems to support the growth of the small pharmaceutical company and led an NDA submission team.  Prior to joining GTx, he was with Eli Lilly and Company from 1995 to 2003, serving as Senior Quality Advisor for Biotechnology in Corporate Quality Assurance and Senior Regulatory Consultant, CMC Regulator Affairs. 

He was with the FDA from 1990 to 1995 in both CDER and CBER where he was Assistant to the Deputy Director.  During his time with Lilly and FDA he represented both PhRMA and the FDA in the International Conference on Harmonization negotiations on four (4) different agreed guidances. 

He approved and signed documents on behalf of both organizations.   He was secretary for all ICH Working Committees for documents on which he worked including Biotech Stability (Q5C), Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process (Q5E); Specifications:  Test Procedures and Acceptance Criteria for Biotechnological/Biological Products (Q6B) and  The Common Technical Document for CMC Submissions (M4).   Dr. Bird holds a Ph.D. in Biochemistry/Entomology from Mississippi State University.

Dr. Gary Bird  PH.D.

GBP $75.00

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