期刊
JOURNAL OF PHARMACEUTICAL SCIENCES
卷 111, 期 3, 页码 608-617出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/j.xphs.2021.09.015
关键词
Protein formulation; Fill-finish operations; GMP; Protein degradation; Protein drug product; Protein aggregation
Biopharmaceuticals for human use present unique challenges in manufacturing, storage, shipment, and administration. There is a lack of regulatory guidance for phase appropriate process development studies for clinical supplies. This review proposes a phase appropriate testing approach for liquid protein formulations.
Biopharmaceuticals for human use present unique challenges during manufacturing, storage, shipment, and administration. Not all drug product process development aspects can and should be studied in detail before entering in first-in human studies (FIH) due to limited resources and the need for new drug candidates to enter phase I clinical studies quickly. Whilst activities for formulation development studies are well defined in literature, there is a lack of regulatory guidance for phase appropriate process development studies for clinical supplies. This review summarizes potential process development studies for liquid protein formulations and proposes a phase appropriate testing approach. (c) 2021 American Pharmacists Association. Published by Elsevier Inc. All rights reserved.
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