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Kashappa Goud Desai
Articles
Small-Scale Syringe and Vial-Filling Capability for Development of Robust Filling Processes, Smooth Tech Transfers, and to Resolve Manufacturing Issues: Summary of Key Learnings
Use of a small-scale filler can result in increased filling efficiency.
Stage 2 Process Validation: Regulatory Expectations and Approaches to Determine and Justify the Number of PPQ Batches
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.
Japan Common Technical Document: Bracketing Strategies for the Manufacturing Process
This article provides an overview on important aspects related to bracketing strategies in Japan.
Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
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.