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Somasundaram Gopalakrishnan

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

Articles by Somasundaram Gopalakrishnan

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

ByRamesh Raju Mavuleti,K. Vasantakumar Pa,K. Sreedhara Ranganath Pai,Subhasis Banerjee ,Somasundaram Gopalakrishnan,Tathagata Ray

June 6th 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

ByRamesh Raju Mavuleti,K. Vasantakumar Pa,K. Sreedhara Ranganath Pai,Subhasis Banerjee,Somasundaram Gopalakrishnan,Tathagata Ray

March 15th 2024

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

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