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Characterization of the Physical Stability of a Lyophilized IgG1 mAb After Accelerated Shipping-like Stress

Upon exposure to shaking stress, an IgG1 mAb formulation in both liquid and lyophilized state formed subvisible particles. Since freeze-drying is expected to minimize protein physical instability under these conditions, the extent and nature of aggregate formation in the lyophilized preparation was...

詳細記述

保存先:
書誌詳細
出版年:J Pharm Sci
主要な著者: Telikepalli, Srivalli, Kumru, Ozan S., Kim, Jae Hyun, Joshi, Sangeeta B., O'Berry, Kristin B., Blake-Haskins, Angela W., Perkins, Melissa D., Middaugh, C. Russell, Volkin, David B.
フォーマット: Artigo
言語:Inglês
出版事項: 2014
主題:
オンライン・アクセス:https://ncbi.nlm.nih.gov/pmc/articles/PMC4312241/
https://ncbi.nlm.nih.gov/pubmed/25522000
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1002/jps.24242
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