Stabilization Approaches for Protein Pharmaceuticals

S. M. Kumar, G. Chhabra, K. Pathak, D. Pathak

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.

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-

  • The assurance of purity and potency of these complex molecules as they offer stability problems.

  • 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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