Clinical Manufacturing

The PCT service platform helps cell therapy developers with their clinical manufacturing challenges. From start to finish, we help clients develop and advance their therapeutics with commercialization in mind. Leveraging our cell therapy-focused experience, we help clients improve their cost-effectiveness, regulatory compliance, and time-to-market.

Our service approach to clinical manufacturing begins with a strategic approach to technology transfers. Our team of experts has rapidly executed high profile successful technology transfers.

Scheduling and Logistics.

We understand the challenges inherent to patient-specific cell therapy logistics. The cost of idle capacity for cell therapies can be enormous—driving up the total cost of goods (COG) for a therapy. Handling clinical manufacturing through us helps cell therapies minimize the impact of scheduling limitations on their COG. To ensure rapid deployment of cell therapies upon completion, our logistics network includes relationships with a specialty air carrier fleet with more than 130 aircraft serving 100+ cities nationwide.

Materials Control, Warehousing, and Procurement.

We have years of experience in creating a secure supply chain for cGMP-compliant cell therapy manufacturing. Our robust procurement sources, warehousing options, and materials controls help clients keep costs down while minimizing risk of supply chain disruptions.

Quality Control and Assurance.

We use a Development by Design (DbD) strategy that addresses issues of quality, scalability, sustainability, and cost of goods at each phase of the process, from stage 1 clinical trials to commercialization. This includes the identification of Critical Quality Attributes (CQAs) that are adjusted as the cell therapy product continues to develop towards commercialization. This is reinforced with automation, closed-system design, and various regulatory compliance tools to help assure strict quality and safety controls for a cell therapy.

Manufacturing Development.

The PCT service platform helps cell therapy developers optimize their manufacturing processes with a variety of manufacturing development services. Our Strategic Commercial Manufacturing Plan incorporates evaluations of your current manufacturing state, analyses of optimization opportunities, and recommendations for achieving commercial readiness to create a commercially-viable product.

 

Technical Services and Engineering Support.

We have years of experience in helping cell therapy developers from all backgrounds with their technical and engineering challenges. Technical services, such as technology transfers, are handled by an experienced team that has dozens of successful transfers to their credit.

Facilities and Equipment Management.

We can provide outsourced manufacturing for cell therapies and consulting for cell therapy developers to help them manage their own facility equipment management.

Information Systems.

This includes services such as Laboratory Information Management Systems (LIMS), Manufacturing Execution Systems (MES), Document Management Systems (DMS) and more—all to help you track, manage, and execute your cell therapy development and manufacturing as efficiently as possible.

Learn more about DbD:

Learn more about DbD: