Case Studies

Compliance oversight of the process development and validation of a Biosimilar active ingredient manufacturing at a CMO on behalf of the sponsor biopharmaceutical company

Objective Providing GMP compliance oversight to the process scaling-up and validation of a complex biosimilar manufacturing by a qualified contract manufacturing organization, up to Marketing Authorization Application filing, responses to…

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Providing expert support to the external manufacturing operations department of a Major Pharma during the technology transfer of a blockbuster product from in-house manufacturing to a third party CMO

Objective Oversight of the technology transfer of a blockbuster status injectable product from in-house production to a qualified contract manufacturing organization while changing from a solution in vial presentation to…

Continue Reading Providing expert support to the external manufacturing operations department of a Major Pharma during the technology transfer of a blockbuster product from in-house manufacturing to a third party CMO