化学
核磁共振波谱
生物制药
仿制品
色谱法
核磁共振
二维核磁共振波谱
分析化学(期刊)
立体化学
政治学
遗传学
生物
物理
法学
作者
Zahir Akhunzada,Yongmei Wu,Thomas Haby,Dimuthu A. Jayawickrama,Gary McGeorge,Massimilano La Colla,Jeffrey Bernstein,M.A. Semones,Anuji Abraham
标识
DOI:10.1016/j.xphs.2021.03.011
摘要
1H Time-Domain Nuclear Magnetic Resonance (TD-NMR) is used to characterize solutions of antibodies that simulate biologic pharmaceutical formulations. The results from these measurements are compared with those from solutions in which the concentration or identity of the antibody has been altered. TD-NMR is shown to be very sensitive to differences in the amount of antibody in solution, with the ability to detect variations in as low as 2 mg/mL. It is therefore capable, by comparison with data from known formulations, of determining whether a particular sample is likely to be of an authentic biologic formulation. This method expands on the previous use of HPLC, UV/VIS, Near-IR and High-Resolution NMR to detect adulterated pharmaceutical materials. While the sensitivity of the method is high, it is a fingerprinting methodology, illustrating differences but not elucidating their origin. The extracted relaxation times reflect the combined effect of all solutes (antibody, buffer components, etc.) on the solvent (water).
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