Clinical Trial Material
Production and Testing
Is Your CMO Providing Everything You Need?
A white paper by Alexander Mello of Microtest Laboratories.
With the intense focus on timely clinical trial material (CTM) production, many companies are looking for a cGMP contract manufacturing organization (CMO) that can perform all of the required processes needed to release their material for clinical trial use. These processes include excipient and API release for GMP manufacture, formulation, in-process testing, environmental monitoring, filter integrity testing, and final release testing.
This paper reviews the key issues pharmaceutical companies must consider when selecting a CMO for CTM production. It discusses the advantages and disadvantages of using a full-service CMO versus one that must subcontract testing and other work.