PCT’s Strategic Commercial Manufacturing Plan (SCMP) allows the cell therapy developer to inform and align its stakeholders, make informed choices as to its needs to fund further development, plan for future-state unit operations and project COGs both at commercial launch and at scale post-launch. The SCMP provides the developer with actionable recommendations including a breakdown of the cost, duration, timing, justification and expected impact of each development and optimization objective for its product candidate.
The SCMP is a robust plan that includes and exceeds the content of the Strategic Manufacturing Assessment and Quality Risk Analysis.
The SCMP includes three primary segments:
It is important to note that while the scope of the SCMP is focused on manufacturing development, the plan must be crafted and executed in the context of all the other elements of product development.
The SCMP is most appropriate for a cell therapy product developer with