期刊
ADVANCED DRUG DELIVERY REVIEWS
卷 172, 期 -, 页码 211-233出版社
ELSEVIER
DOI: 10.1016/j.addr.2021.02.016
关键词
Protein solids; Drying technology; Solid-state characterization; Process stress; Physical stability
资金
- National Institute of Allergy and Infectious Diseases of the National Institute of Health [R01AI146160, R01AI132681]
This review explores the challenges in formulation development of biologics in solid form, as well as traditional and emerging drying techniques. Stresses during the drying process can impact the stability of protein solids, but the lack of reliable characterization techniques for biological solids makes it challenging to understand their effects on protein product quality. Advanced characterization tools offer potential for mechanistic investigations into local structural changes and interactions at higher resolutions.
Despite the boom in biologics over the past decade, the intrinsic instability of these large molecules poses significant challenges to formulation development. Almost half of all pharmaceutical protein products are formulated in the solid form to preserve protein native structure and extend product shelf-life. In this review, both traditional and emerging drying techniques for producing protein solids will be discussed. During the drying process, various stresses can impact the stability of protein solids. However, understanding the impact of stress on protein product quality can be challenging due to the lack of reliable characterization techniques for biological solids. Both conventional and advanced characterization techniques are discussed including differential scanning calorimetry (DSC), solid-state Fourier transform infrared spectrometry (ssFTIR), solid-state fluorescence spectrometry, solid-state hydrogen deuterium exchange (ssHDX), solid-state nuclear magnetic resonance (ssNMR) and solid-state photolytic labeling (ssPL). Advanced characterization tools may offer mechanistic investigations into local structural changes and interactions at higher resolutions. The continuous exploration of new drying techniques, as well as a better understanding of the effects caused by different drying techniques in solid state, would advance the formulation development of biological products with superior quality. (c) 2021 Elsevier B.V. All rights reserved.
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