Kashappa Goud Desai

Kashappa Goud Desai is scientific leader, Process Engineering and Analytics, Drug Product Development, GSK.

Articles by Kashappa Goud Desai

Medical syringe with liquid and droplet on white background. Parts of syringe: needle, syringe barrel, plunger, cap, dosage scale | Image Credit: © Matsabe - © Matsabe - stock.adobe.com

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

ByKevin Hutter,Kashappa Goud Desai,Igor Rusanov,Aarti Gidh

July 1st 2023

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

ByKashappa Goud Desai,James D. Colandene,Richard A. Lewis,Douglas P. Nesta

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

ByJames 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

ByPeter 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.