Cell bank characterization for manufacture of Biopharmaceuticals
Online Training Id: GMP-004
Geographical Region: Global
Duration: 1 hr
In this presentation we will consider the principals for the Characterisization and qualification of cell substrates, viral seeds, and other biological materials used for the production of Biopharmaceuticals for human use. We shall review the use of cell substrates which are categorized as primary (cells, including eggs, derived directly from an animal source and that are not stored as cell banks), diploid (cells with a normal or near-normal karyotype and that are stored as cell banks prior to use in vaccine manufacture), or continuous (cells that are immortal and do not undergo senescence). This is an essential party in the development of Biosimilars since minor variations in the structure of a molecule similar to the original product can produce very different physiological effects.
In this eLecture we will review;
Regulatory Guidance for the Characterization and Qualification of Cell Banks
Creating a Cell bank for Preparation of the Master and working cell Banks.
Characterization of Cell Banks
Identification and characterization of cultured cells by analysis
Release and retesting of cell banks
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.