By David B. Volkin, Gautam Sanyal (auth.), Steve L. Nail, Michael J. Akers (eds.)

In this period of biotechnology there were many books masking the basics of recombinant DNA know-how and protein chemistry. notwithstanding, no longer many assets can be found for the pharmaceutical boost­ ment scientist and different team of workers chargeable for the commercialization of the completed dosage sorts of those new biopharmaceuticals and different items from biotechnology. this article will support to fill this hole. as soon as lively biopharmaceutical molecules are applicants for medical trial research and next commercialization, a few different actions needs to occur whereas study and improvement on those molecules maintains. The energetic aspect itself has to be formulated right into a accomplished dosage shape that may be very easily utilized by wellbeing and fitness care execs and sufferers. houses of the biopharmaceutical molecule needs to be basically understood in order that the proper accomplished product formula could be built. accomplished product formula improvement contains not just the chemical formula, but in addition the packaging method, the producing strategy, and applicable keep watch over concepts to guarantee such reliable production perform attributes as protection, id, energy, purity, and quality.

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Reprinted with permission from Volkin et al. (l995b). Copyright 1995 Humana Press. 32 David B. Vol kin et at. ding the asparaginyl and aspartyl residues affect the rate at which deamidation and isoaspartate formation can occur. In general, Asn-Gly and Asn-Ser are the most labile sequences as a consequence of the minimum steric hindrance to cyclic imide formation provided by absent and small Gly and Ser side chains, respectively. Increased conformational flexibility also enhances deamidation by providing conformational mobility, which permits the peptide bond to more readily participate in the cyclic imide formation.

The isomerization of aspartyl residues to isoaspartyl can also occur via the same cyclic imide intermediate mechanism. H, -co- NH- CH-CO-NH- ~H, ~ -co- NH-CH-CO-NHAsparagine /CO, CH, N\ / -CO-HN-CH-CO Aspartic Acid CO-NH- Cyclic Imide I CH, - co- NH- tH - CO? /soasparlic Acid Figure 6. Deamidation and isoaspartate formation at asparginyl residues in proteins and peptides. Reprinted with permission from Volkin et al. (l995b). Copyright 1995 Humana Press. 32 David B. Vol kin et at. ding the asparaginyl and aspartyl residues affect the rate at which deamidation and isoaspartate formation can occur.

Thus, maintaining the biologically active form of a protein requires preserving its overall size, both by preventing aggregation and, in the case of oligomeric proteins, maintaining quaternary structure (Schein, 1994). A rational approach to the formulation of a stable pharmaceutical protein therefore involves a prior detailed understanding of a protein's overall size and quaternary structure as well as its association/aggregation behavior, in addition to its conformational stability and chemical integrity.

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