Download Development and Manufacture of Protein Pharmaceuticals by David B. Volkin, Gautam Sanyal (auth.), Steve L. Nail, PDF

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

In this period of biotechnology there were many books protecting the basics of recombinant DNA know-how and protein chemistry. in spite of the fact that, no longer many assets can be found for the pharmaceutical boost­ ment scientist and different body of workers accountable for the commercialization of the completed dosage types of those new biopharmaceuticals and different items from biotechnology. this article will aid to fill this hole. as soon as energetic biopharmaceutical molecules are applicants for scientific trial research and next commercialization, a couple of different actions needs to occur whereas learn and improvement on those molecules keeps. The lively element itself has to be formulated right into a complete dosage shape that may be very easily utilized by future health care pros and sufferers. homes of the biopharmaceutical molecule needs to be in actual fact understood in order that the best complete product formula should be built. comprehensive product formula improvement contains not just the chemical formula, but additionally the packaging method, the producing approach, and acceptable regulate suggestions to guarantee such solid production perform attributes as safeguard, id, energy, purity, and quality.

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Extra resources for Development and Manufacture of Protein Pharmaceuticals

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The Gdn·HC1-induced equilibrium unfolding profile of iso-I-cytochrome monitored by this technique has been found to be strikingly similar to that determined by CD (220 nm), as shown in Fig. , 1993). In another pharmaceutically relevant application of FTIR spectroscopy, temperature-induced aggregation of chymotrypsinogen in D 20 solution has been systematically studied by Ismail et al. (1991), by monitoring the appearance of a relatively strong band at 1618 cml and a weaker one at 1685 cm-I . These bands, which have consistently been seen in aggregating protein systems, have been assigned to intermolecular f3 sheets and their presence permits a rapid identification of this phenomenon.

In such cases, other methods, such as SEC-HPLC or Preformulation Studies 27 analytical ultracentrifugation, should be used in conjunction with light scattering measurements to ensure an accurate description of particle size distribution. 6. Mass Spectrometry Compared to the methods discussed previously, mass spectrometry provides the most accurate molecular mass value. , 1991). 2). , 1991). However, a homogeneous sample is usually required to take maximum advantage of the technique. This will usually involve purification or separation before introduction into the instrument.

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 oxidation of protein amino acid side chains under typical formulation conditions occurs primarily at the sulfur-containing amino acid residues cysteine and methionine. Protein-bound cysteine residues can oxidize to form inter- or intramolecular disulfide bonds or monomolecular byproducts, such as sulfenic and sulfinic acid (only harsher oxidation conditions can lead to irreversible formation of sulfonic acid): 2 Protein-CH2 SH Cysteine Protein-CH 2SH Cysteine -t -t Protein-CH 2S-SCH2 -Protein Cystine Protein-CH 2SOH Sulfenic acid -t Protein-CH2S02H Sulfinic acid -t Protein-CH 2S03H Sulfonic acid Similarly, the oxidation of protein-bound methionine residues results in the conversion of the thioether to its sulfoxide counterpart (whereas only more severe oxidation conditions lead to the formation of the sulfone): Protein-CH 2CH 2SCH 3 - t Protein-CH 2CH 2S(O )CH3 Methionine Methionine sulfoxide -t Protein-CH 2CH 2S(00 )CH3 Methionine sulfone Protein oxidation can occur through two general mechanisms, which involve (1) site-specific (metal-catalyzed) and (2) non-site-specific oxidation.

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