期刊
JOURNAL OF PHARMACEUTICAL SCIENCES
卷 106, 期 4, 页码 994-1000出版社
WILEY
DOI: 10.1016/j.xphs.2016.11.021
关键词
protein aggregation; microparticles; protein formulation; physical stability; biopharmaceutical characterization; monoclonal antibody
资金
- MedImmune summer internship program
It is vital to understand the impact of transportation on monoclonal antibody (mAb) product quality during drug product development. Fully representative real-time shipment studies are resource intensive, so in this work, we studied laboratory agitation methods to mimic the effect of real-time shipment on aggregation, specifically subvisible particle formation. The agitation methods studied include a rotator, orbital shaker, vortexer, and shipping simulator vibration table. The simulator is able to predict the particle formation behavior during real-time shipment for a number of mAbs in vial and prefilled syringe configurations, with a correlation of about 90%, whereas the other methods of agitation were inconsistent. This study demonstrates that using a shipping simulator vibration table provides an opportunity for consistent and predictive development studies of shipping stress with minimal resource requirements during early- or late-stage drug product development. (C) 2017 American Pharmacists Association (R). Published by Elsevier Inc. All rights reserved.
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