By a News Reporter-Staff News Editor at Drug Week -- Fresh data on Immunology are presented in a new report. According to news reporting from San Francisco, California, by NewsRx journalists, research stated, "Monoclonal antibody (mAb) fragments are emerging as promising alternatives to full-length mAbs as protein therapeutic candidates. Antigen-binding fragments (Fabs) are the most advanced with three Fab-based drug products currently approved."
The news correspondents obtained a quote from the research from Genentech, Inc., "This work presents preformulation characterization data on the effect of pH, NaCl concentration, and various cationic excipients on the physical and chemical stability of a Fab molecule with multiple negatively charged Asp residues in the complementarity-determining region. Conformational stability was evaluated using an empirical phase diagram approach based on circular dichroism, intrinsic Trp and extrinsic 8-anilino-1-naphthalene sulfonate (ANS) fluorescence, and static light scattering measurements. The effect of NaCl concentration, various cationic excipients and pH on the Fab molecule's conformational stability, aggregation propensity, and chemical stability (Asp isomerization) was determined by differential scanning calorimetry, optical density measurements at 350nm (OD350), and ion-exchange chromatography, respectively. Increasing NaCl concentration increased the overall conformational stability, decreased aggregation rates, and lowered the rates of Asp isomerization. No such trends were noted for pH or cationic excipients."
According to the news reporters, the research concluded: "The potential interrelationships between protein conformational and chemical stability are discussed in the context of designing stable protein formulations."
For more information on this research see: Effect of ionic strength and pH on the physical and chemical stability of a monoclonal antibody antigen-binding fragment. Journal of Pharmaceutical Sciences, 2013;102(8):2520-2537. Journal of Pharmaceutical Sciences can be contacted at: Wiley-Blackwell, 111 River St, Hoboken 07030-5774, NJ, USA. (Wiley-Blackwell - www.wiley.com/; Journal of Pharmaceutical Sciences - onlinelibrary.wiley.com/journal/10.1002/(ISSN)1520-6017)
Our news journalists report that additional information may be obtained by contacting T.T. Wang, Genentech Inc, Prot Analyt Chem, San Francisco, CA 94080, United States. Additional authors for this research include O.S. Kumru, L. Yi, Y.J. Wang, J. Zhang, J.H. Kim, S.B. Joshi, C.R. Middaugh and D.B. Volkin (see also Immunology).
Keywords for this news article include: Antibodies, California, Immunology, San Francisco, United States, Blood Proteins, Immunoglobulins, North and Central America
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