Somasundaram Gopalakrishnan

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Somasundaram Gopalakrishnan, is senior consultant, Global Biopharm Center of Excellence, Merck Pte. Ltd.

Articles

Close-up of tubes in Brookhaven National Laboratory | Image Credit: © Bill Gallery - © Bill Gallery - stock.Adobe.com

Application of the Risk Evaluation Matrix as per USP <665> and <1665> for Evaluation of Leachables Risk from Single-Use Components Used in Biomanufacturing

Ramesh Raju Mavuleti;K. Vasantakumar Pa;K. Sreedhara Ranganath Pai;Subhasis Banerjee;Somasundaram Gopalakrishnan;Tathagata Ray
May 16th 2024

Determining E&L risk from single-use components can be used to build the level of extractable profiling and PERLs.

bag of medical serum | Image Credit: © mailsonpignata - © mailsonpignata- Stock.adobe.com

Review of SUT Adoption in Biopharma Manufacturing

Ramesh Raju Mavuleti;K. Vasantakumar Pa;K. Sreedhara Ranganath Pai;Subhasis Banerjee;Somasundaram Gopalakrishnan;Tathagata Ray
March 16th 2024

The evolution of therapeutic modalities drives the adoption of single-use technologies.

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