How do we assure the quality of biological medicines?

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 an...

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Veröffentlicht in:	Drug discovery today 2009, Vol.14 (1), p.50-55
Hauptverfasser:	Longstaff, Colin, Whitton, Colin M., Stebbings, Richard, Gray, Elaine
Format:	Artikel
Sprache:	eng
Schlagworte:	Antibodies, Monoclonal - chemistry Antibodies, Monoclonal, Humanized Biological and medical sciences Biological Products - standards Drug Industry - legislation & jurisprudence Drug Industry - methods General pharmacology Heparin - standards Humans Legislation, Drug Medical sciences Pharmaceutical technology. Pharmaceutical industry Pharmacology. Drug treatments Quality Control Streptokinase - standards
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Beschreibung
Zusammenfassung:	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.
ISSN:	1359-6446 1878-5832
DOI:	10.1016/j.drudis.2008.09.010