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Abstract: Since last two decades protein based
pharmaceuticals have become an important class of potent
therapeutic drug. However the major limitation is
degradation of protein by physical and chemical factors.
This presents a challenge to formulation scientist for
development of stable protein based pharmaceuticals. The
study of factors causing protein degradation and
mechanism by which protein can stabilize can help in the
formulation of protein based pharmaceuticals.
Introduction
The development of biotechnology based methods has
established biotechnology as a mainstay in
pharmaceutical research and development, and new protein
based products are available in clinically useful
quantities and will enter the market at an increasing
pace during the next decade of the millennium. The major
challenges to a pharmaceutical scientist in designing a
suitable dosage form or drug delivery system for
biopharmaceutical product are-
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The assurance of purity and potency of these complex
molecules as they offer stability problems.
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The development of method to improve the absorption
of larger molecules and promoting their transport
and diffusion across the membrane.
Protein Stabilization
Protein stabilization can be defined as tendency to
maintain its native conformation. The many important
techniques which are involved in the production of
biopharmaceuticals are molecular biology, r-DNA
technology, hybridoma technology, fermentation
technology and tissue culture technology.2 These
techniques provide exciting opportunities for new
pharmaceuticals development and new approaches to
diagnosis, treatment, and prevention and to combat
poorly controlled diseases by peptide and protein based
drugs. There are dozens of protein formulation in the
market and hundreds more in the pre clinical and
clinical development. Protein and peptide drugs are in
demand due to following properties molecular size, short
plasma half life, tendency to undergo self association,
requirement for specialized mechanism for transport
across biological membranes, complex feed back control
mechanism, susceptibility to breakdown in both physical
and biological environment.
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