By Joe Makowiecki, Enterprise Solution Architect, GE, Patrick McMahon, Fast Trak Bridge Manufacturing Services Operations Leader, GE and Sven Frie, Modality Leader, Enterprise Solutions EMEA & Asia, GE
Drug development is inherently risky. The high stakes associated with producing a lifesaving drug can weigh on a manufacturer. Every decision can make or break a project, and, unfortunately, many are made long before anyone knows if the drug will make it to market. This is compounded by the fact that so much of the work that goes into drug development is done in silos, weakening the potential for vital cross-functional communication and collaboration.
One solution to drug development challenges is adopting a parallel operations business model. This approach affords the opportunity to develop a process or to perform cGMP manufacturing in a parallel path using the resources of an external contract development and manufacturing organization (CDMO) while simultaneously establishing your manufacturing capabilities. In the end, you can mitigate the risks of drug development, reduce your capital costs, and get ahead of your competition by increasing your speed to market. This article provides several recommendations for how parallel operations can be leveraged in your biomanufacturing strategy.