Requirements of Master & Working Cell Banks for Biopharmaceuticals manufacture

Online Training Id: GMP-003

Geographical Region: Global

Level: Intermediate

Duration: 4 hrs

Cell culture is the process by which cells are grown under controlled conditions, generally outside of their natural environment. In practice, the term "cell culture" now refers to the culturing of cells derived from multi-cellular eukaryotes, especially animal cells.

Learning Objectives:

This eLearning Course will provide an overview to the process of cell culturing and cell banking, and define the technical and regulatory requirements for the manufacture of biopharmaceuticals and biologicals by the use of cell culture and will consider;

  • Cell Culture; the method/process to grow cells

  • Transfection; Biological, chemical, and/or physical methods for introducing the replicable genetic material (nucleic acids) into cells

  • Reactor types; the different types of devices or systems that support a biologically active environment

  • Nutritional requirements of the Cell Culture media

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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