By Rodney Pearlman, Y. John Wang
Top scientists supply designated profiles of ten protein medicines at the moment in improvement. The case histories of those very important new compounds are defined from the point of view in their formula, characterization, and balance. This prepared reference additionally positive aspects contemporary facts and an abundance of formerly unpublished info. The in-depth assurance incorporates a hugely beneficial compendium of deterioration websites taking place in over 70 proteins. a useful reduction within the quick id of capability `hot spots' in proteins, this obtainable compilation enables inspection of the protein's fundamental constitution and practise of a hydroflex plot.
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Additional resources for Formulation, Characterization, and Stability of Protein Drugs: Case Histories (Pharmaceutical Biotechnology, 9)
Example text
Deamidation was found to be slow for this protein below neutral pH; however, the exact sites of deamidation were not determined, and deamidation was identified only by an acidic shift in the IEF pattern. Antibody OKT4a Light Chain (humanized) (214 residues) SEQUENCE DIQMTQSPSSLSASVGDRVTITCKASQDINNYIAWYQQTPGKAPKLLIHYTSTLQPGVPSRFSGSGSGTDYTFTISSLQPEDIATYYCLQYDNLLFTFGQGTKLQITRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC • 36 Michael F. Powell PREDICTED REACTIVITY AND DEGRADATION OF OKT4a LIGHT CHAIN This light chain has few reactive sites, suggesting that the OKT4a heavy chain is the major site of chemical degradation.
Asn-18 and Asn-22 are adjacent to Thr, which is reported to activate reactivity at Asn only slightly. 0), approaching the desired pH range for parenteral formulations. 2:2), consistent with cyclic imide formation. Deamidation at Asn-18 was not detected (Darrington, 1995). , 1983). No controls were carried out to determine if this deamidation was due to isolation or differences in protein expression from different patients. 5 at 5°C. Angiogenin (123 residues) SEQUENCE EDNSRYTHFLTQHYDAKPQGRDDRYCESIMRRRGLTSPCKDINTFIHGNKRSIKAICENKNGNPHRENLRISKSSFQVTTCKLHGGSPWPPCQYRATAGFRNVVVACENGLPVHLDQSIFRRP · 18 Michael F.
1993a). This study shows that the peroxide-catalyzed degradation of Met has little temperature dependence and is negligibly effected by pH or ionic strength. , 1975) and should be used cautiously in the formulation of Met-containing proteins. , (1993a), it is estimated that 1 nM peroxide in a Metcontaining formulation would shorten the shelf life to less than 2 years. 2. Calculation of Protein Hydropathy and Flexibility The general literature, and Genentech’s GenBank data base, were surveyed for proteins that exhibit deamidation, hydrolysis, cyclization, or oxidation.