Strategic Manufacturing Assessment

A Roadmap for Commercial Cell Therapy Manufacturing

You need a strategy for the long, complex and resource-intensive road from idea to commercialization of a cell therapy. You need a plan to deliver the right quality, cost of goods, scalability and sustainability

No matter what your phase of development or level of experience with cell therapies, PCT can deliver the plan you need with a Strategic Manufacturing Assessment (SMA)

At its core, the SMA is an independent, disciplined, and diagnostic evaluation of a cell therapy process that can be completed in six to eight weeks.

Our detailed analysis will include:

Product Definition

  • Quality target product profile

  • Product critical quality attributes

Manufacturing Definition

  • Current state unit operations

  • Unit operations analysis

Suitability and gap assessment for:

  • Technology transfer

  • Clinical readiness

Recommendations to optimize commercially viable manufacturing

For more information on an SMA from PCT, download the SMA brochure and reach out to the PCT team to learn more.