The authors summarize the current regulatory expectations regarding the number of PPQ batches required and provide potential approaches that can be used to determine and justify the number of PPQ batches.
James D. Colandene
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James D. Colandene, PhD, is manager, Biopharmaceutical Product Sciences, GlaxoSmithKline.
Articles by James D. Colandene
This article provides an overview on important aspects related to bracketing strategies in Japan.
The objective of this study was to assess the impact of manufacturing-scale, freeze-thaw conditions on aggregation and subvisible particle formation of a monoclonal antibody solution (mAb-A; IgG1) using a small-scale model.
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Latest Updated Articles
Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb SolutionPublished: February 1st 2017 | Updated:
Japan Common Technical Document: Bracketing Strategies for the Manufacturing ProcessPublished: May 1st 2017 | Updated:
Stage 2 Process Validation: Regulatory Expectations and Approaches to Determine and Justify the Number of PPQ BatchesPublished: July 1st 2017 | Updated:
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