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...

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Veröffentlicht in:J Pharm Sci
Hauptverfasser: 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.
Format: Artigo
Sprache:Inglês
Veröffentlicht: 2014
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Article
Online Zugang: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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