The Challenge: A client’s first Cell & Gene Therapy facility—over 125 systems requiring full validation from design through GMP release, with shifting requirements throughout.
How Pharmatech Helped: Owned the entire validation lifecycle: design and submittal reviews, factory and site acceptance testing, all commissioning and qualification protocols, and end-to-end schedule management—backed by an accountable document review and approval process.
The Result: cGMP production in under a year from conceptual design. Project earned an ISPE Facility of the Year Award.
