Abstract: Proteins that are engineered in the laboratory for pharmaceutical use are known as therapeutic proteins. A thorough protein pattern represented in body fluids and the changes of it following the development or progression of diseases allow insight in the pathogenesis of most known diseases. This success has been driven by the unique action of the therapeutic protein in the body, replacing dysfunctional natural proteins. The use of protein type pharmaceuticals has several restrictions, which will limit their use and size of market. As proteins, they are unstable, poorly absorbed from gastro intestinal track, easily destroyed/eliminated by the body and can cause unwanted allergic reactions in the patients with long term therapy. Protein based therapeutics are largest class of new chemical entities being developed. Unlike small molecules, which typically are synthesized by chemical means, most proteins are complex macro molecules, which necessitate their production in living systems, mostly by recombination technology.
Through recombination technology higher yields of complex molecules such as proteins and antibodies, which cannot be produced by chemical means, can be achieved. With the advent of recombinant technology exclusive production of an isomeric compound and human therapeutic proteins in large quantities and of high purity is possible. Not only it is possible to produce these biopharmaceuticals in a form identical to that naturally occurring in the body, but also to design meaningful improvements in activity, stability and bioavailability. Such recombinant therapeutic products will also be free of the dangerous contaminants that have occasionally arisen if such products are extracted from animals e.g. Human growth hormone extracted from cadaver is associated with Creutzfeldt-Jakob degenerative brain disease1. Proteins therapeutics for pharmaceutical and clinical use cannot be consistently, sufficiently, safely and cost effectively applied without the recent milestones of biotechnology that include the basic principles of DNA and cell recombination and fermentation. |
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