James D. Colandene

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James D. Colandene, PhD, is manager, Biopharmaceutical Product Sciences, GlaxoSmithKline.

Articles

Stage 2 Process Validation: Regulatory Expectations and Approaches to Determine and Justify the Number of PPQ Batches

James D. Colandene;Douglas P. Nesta;Kashappa Goud Desai;Richard A. Lewis

July 1st 2017

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

James D. Colandene;Douglas P. Nesta;Kashappa Goud Desai

May 1st 2017

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

Peter J. Martin;James D. Colandene;W. Aaron Pruett;Douglas P. Nesta;Kashappa Goud Desai

February 1st 2017

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.