Saroj Ramdas

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Saroj Ramdas is GSK fellow and director, CMC regulatory strategy and advocacy with GlaxoSmithKline.

Articles

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Overcoming Challenges to Biopharmaceutical Development and Manufacture with Science- and Risk-Based Strategies

Saroj Ramdas;Renata Varga;Martin Gastens;Twinkle R. Christian;Bharat Jagannathan;Barbara Rellahan;Jillian Brady
March 16th 2021

Many biologic drug manufacturers encounter similiar challenges; precompetitive collaboration can help resolve these issues. Representatives of the IQ Consortium’s Biologics CMC Leadership Group describe efforts to address the safe handling of biologic drugs in closed-system transfer devices in healthcare settings and the need for phase-appropriate specifications.

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