Related Experiment Video
Updated: Jun 28, 2026

Purification and Analytics of a Monoclonal Antibody from Chinese Hamster Ovary Cells Using an Automated Microbioreactor System
Published on: May 1, 2019
How do we assure the quality of biological medicines?
Colin Longstaff1, Colin M Whitton, Richard Stebbings
1Division of Biotherapeutics Section, National Institute for Biological Standards and Control, Blanche Lane, S. Mimms, Herts EN6 3QG, UK. clongstaff@nibsc.ac.uk
Abstract:
Biological medicines are a rapidly growing area of interest to many pharmaceutical companies, large and small. Under a broad definition they include not only modern high-tech products, such as monoclonal antibodies, enzymes and cytokines, but also older well-established products, such as vaccines and blood products. Despite a long history of standardisation and control of biological medicines, and an elaborate system of licensing and regulation, problems still occur because of their complexity. This review includes historical and regulatory background and three examples of problems seen with biotherapeutics: streptokinase, heparin and TGN1412.
More Related Videos
Related Concept Videos
Drug Products: Biologics, Biosimilars and Interchangeables
Good Manufacturing Practices
Bioequivalence: Overview
Bioavailability Enhancement: Determination and Conceptual Approaches in Overcoming Bioavailability Problems
Clinically Relevant Drug Product Specifications: Methods of Establishment
Bioequivalence studies: Biowaivers

