Biopharmaceutical
From Free net encyclopedia
- The term biopharmacology also describes a field of research closely related to pharmacokinetics, sometimes called biopharmacy.
Biopharmaceuticals are medical drugs (see pharmacology) produced by biotechnology. They are actually proteins or nucleic acids (DNA and RNA) used for therapeutic or in vivo diagnostic purposes, which is produced by means other than direct extraction from a native (non-engineered) biological source.
The first such substance approved (1982) for therapeutic use was recombinant human insulin, (rHI, trade name Humulin) developed by Genentech and marketed by Eli Lily.
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Classification of Biopharmaceuticals
- Blood factors (Factor VIII and Factor IX)
- Thrombolytic agents (tissue plasminogen activator)
- Hormones (Insulin, growth hormone, gonadotrophins)
- Haematopoietic growth factors (Erythropoietin, colony stimulating factors)
- Interferons (Interferons-α, -β, -γ)
- Interleukin-based products (Interleukin-2)
- Vaccines (Hepatitis B surface antigen)
- Monoclonal antibodies (Various)
- Additional products (tumour necrosis factor, therapeutic enzymes)
Uses
- Erythropoietin - Treatment of anaemia
- Interferon-α - Treatment of leukaemia
- Interferon-β - Treatment of multiple sclerosis
- Monoclonal antibody - Treatment of rheumatoid arthritis
- Colony stimulating factors - Treatment of neutropenia
- Glucocerebrosidase - Treatment of Gaucher's disease
Large scale production
Biopharmaceuticals may be produced from microbial cells (e.g. recombinant E. coli), mammalian cell lines (See Cell culture) and plant cell cultures (See Plant tissue culture) in bioreactors of various configurations.
Important issues of concern are cost of production (low volume high purity product) and microbial contamination (bacteria, virus, mycoplasma, etc). Alternative platforms of production that are being tested include whole plants (Plant-made pharmaceuticals).
See also
Reference
- Walsh, G. Biopharmaceuticals: Biochemistry and Biotechnology, Second Edition. John Wiley & Sons Ltd: ISBN 0470843268 (ppc), ISBN 0470843276 (pbk)Template:Pharma-stub