Somasundaram Gopalakrishnan

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

Articles

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

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

Review of SUT Adoption in Biopharma Manufacturing

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