Biotech Manufacturing processes to produce Biopharmaceuticals

Online Training Id: GMP-005

Geographical Region: Global

Level: Intermediate

Duration: 2 hrs

This lecture will demonstrate that Biopharmaceutical manufacturing processes are highly product specific and almost always designed to fit the Biopharmaceutical molecule, and provides the delegate with the following skills.

  • A specific scientific knowledge of Biopharmaceuticals manufacture

  • The techniques used in Biopharmaceutical Manufacture

  • Specify the Equipment necessary to manufacture Biopharmaceuticals

Learning Objectives:

This course provides the delegate with an understanding of;

  • The requirements of master and working cell banks for products produced by Cell culture

  • An understanding of transient and stable transfection

  • The different types of Bioreactors used in Cell culture

  • The nutritional requirements for ell 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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