Protein Therapeutics and the Regulation of Quality: A Brief History - As the biotechnology industry has matured through various stages of growth, regulatory agencies have evolved in response to the ne

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Protein Therapeutics and the Regulation of Quality: A Brief History
As the biotechnology industry has matured through various stages of growth, regulatory agencies have evolved in response to the need to define quality standards.


BioPharm International
Volume 20, Issue 10

2001 The Tufts Center for the Study of Drug Development estimates the cost of new drug development at over $800 million dollars.

2001 Darbepoetin, a variant of erythropoietin genetically engineered to include two additional glycosylation sites, approved.

2002 Koichi Tanaka and John Fenn shared Nobel Prize for chemistry for the development of mass spectrometry in protein chemistry.

2002 Market for biotechnology products represents approximately $30 billion of $400 billion in yearly worldwide pharmaceutical sales.

2002 Adalimumab, a fully human antibody generated using phage display technology, approved.

2002 Publication of information about transfusion-dependent pure red cell aplasia (PRCA) cases in patients receiving recombinant erythropoietin highlighted risks of immunogenicity.

2002 FDA announces its "Pharmaceutical Current Good Manufacturing Practices for the 21st Century" initiative.

2002 OTRR's Division of Cell and Gene Therapy is made a separate office.

2002 A number of recombinant enzymes for lysosomal storage diseases (such as Fabry disease, some forms of mucopolysaccharoidoses, and Pompe disease) approved. Two fusion proteins and two antibodies that target adhesion and costimulatory molecules also approved.

2003 OTRR is transferred to CDER. Review responsibilities were divided between the Office of New Drugs and the Office of Pharmaceutical Science (OPS). OTRR is split into the Office of Drug Evaluation 6 (ODE6) and the Office of Biotechnology Products (OBP).

2004 ICH finalizes Guidance for Industry: Comparability of Biotechnology/Biological Products Subject to Changes in Their Manufacturing Process (Q5E).

2004 FDA's Critical Path initiative launched with release of Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products.

2004 FDA cosponsors meetings on scientific considerations for developing follow-on protein products, and cosponsors a New York Academy of Sciences follow-on biologics workshop.

2004 FDA finalizes Guidance for Industry: PATA Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance.

2005 EMEA's Guideline on Similar Biological Medicinal Products finalized.

2006 Panitumumab, a fully human antibody generated using transgenic animals and one of a number of biotechnology products that target epidermal growth factor (EGF) or vascular endothelial growth factor (VEGF) pathways, approved.

2006 FDA approves Omnitrope under the 505(b)(2) (generic) pathway of the Food, Drug, and Cosmetic Act.

2006 ICH finalizes Guidance for Industry: Pharmaceutical Development (Q8), focusing on the development of a manufacturing design space, and Guidance for Industry: Quality Risk Management (Q9).

2006 An inhaled form of insulin (Exubera) approved, expanding protein products into a new dosage form.

2006 FDA issues Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations.

2007 ICH releases the draft Guideline for Industry: Pharmaceutical Quality System (Q10) for consultation.


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