Clinical Phage Production - Design/Build/Qualify
Challenge from the Client
A start-up biotech company was looking to generate phase 1 and phase 2 clinical material for a phage-based therapy on an aggressive timeline and tight budget.
Our Approach & Solution
By bringing isolation/closure of the entirety of the process (cell culture, infection, purification, formulation, filling) a small existing lab space was able to be minimally renovated.
This approach allowed the client to go from business need identification to qualified space for drug substance and aseptic drug product in four months.