White Paper: Clinical Trial Material Production And Testing: What Your CMO Is Not Telling You

By Alexander Mello, Director, Project Management

Manufacturing clinical trial material (CTM), and the costs for the associated fill/finish and release work, most likely are not the costliest portions of the pharmaceutical process chain. But delays in starting the clinical trial can make the most dogged project managers wince in pain. As they approve a change order for the delay, they know a gap has been created in the project's timeline and budget. With the intense focus today on timely CTM manufacture (to keep clinical protocols on time and on budget), many companies are looking for cGMP contract manufacturing organizations (CMOs) 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. CMOs with the most capability and flexibility can produce CTM much quicker than those that must subcontract the work to an approved GMP testing house. Their expertise and expansive services portfolio allow the product to be released faster to the clinic, minimizing any impact on the timeline and cost of the specified clinical protocols.