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

The Evolution of Protein Therapeutics and the Regulation of Quality: A Timeline

1953 First accurate model of DNA suggested.

1961 Genetic code deciphered, paving the way to genetic engineering and biotechnology.

1976 DNA technology guidelines (now known as NIH Guidelines for Research Involving Recombinant DNA Molecules) issued by the National Institutes of Health.

1982 Human insulin, created using recombinant DNA technology, introduced.

1985 Growth hormone first manufactured using recombinant DNA technology.

1986 Interferon alfa and muromonab-CD3 approved.

1987 Alteplase, produced using Chinese hamster ovaries, approved.

1988 FDA's Center for Drugs and Biologics divided into two organizations: Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).

1989 Erythropoietin, granulocyte colony stimulating factor (G-CSF), and granulocyte macrophage colony stimulating factor (GM-CSF) approved.

1992 In111 satumomab, a monoclonal radiolabeled imaging agent, approved.

1992 Prescription Drug User Fee Act (PDUFA) allows FDA to collect application fees, providing resources to meet timelines and improve management of review process.

1993 First interferon beta approved for use in treating multiple sclerosis; dornase alfa marketed to treat complications of cystic fibrosis.

1993 CBER's Office of Therapeutics Research and Review (OTRR) formed.

1994 Abciximab, an antibody fragment that is chimeric (with the constant regions having human instead of murine sequences), approved.

1994 Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Usage published by CBER.

1995 ICH finalizes Analysis of the Expression Construct in Cells Used for the Production of rDNA Derived Protein Products (Q5B) and Stability Testing for Biotechnology/Biological Products (Q5C).

1995 FDA issues Guidance Document Concerning Use of Pilot Manufacturing Facilities for the Development and Manufacture of Biological Products.

1996 FDA issues Guidance Concerning Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology Derived Products.

1997 First whole chimeric antibody, rituximab, and first humanized antibody, daclizumab, approved.

1997 To keep up with advances in manufacturing, CBER revises Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Usage.

1997 ICH issues Viral Safety Evaluation of Biotechnology Products Derived from Lines of Human or Animal Origin and Derivation (Q5A) and Derivation and Characterization of Cell Substrates Used for the Production of Biotech-nology/Biological Products (Q5D).

1997 Food and Drug Administration Modernization Act (FDAMA) establishes a new approach to reporting manufacturing changes.

1997 FDA Guidance for Industry: Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products fleshes out the regulations for reporting manufacturing changes.

1998 Etanercept, the first fusion protein, approved.

1999 Denileukin difitox, a fusion of interleukin2 and diphtheria toxin fragments, approved.

1999 ICH finalizes Guidance on Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products (Q6B).

1999 OTRR's Divisions of Hematologic Products and Cytokine Biology are combined into the Division of Therapeutic Proteins.

2000 A calicheamicin antibody conjugate approved.

2001 Marketing began for PEGylated versions of previously approved growth factors (G-CSF and GM-CSF) and interferons.


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