Storage, Distribution, & Delivery
Cell & Tissue Storage
PCT's cryogenic storage facilities provide the capacity for short-term and long-term storage of tissues, primary cells, and cell therapy products at temperatures ranging from -85°C to -196°C (liquid nitrogen), under full cGMP control.
PCT can also offer storage risk mitigation services through product segregation between our East and West Coast facilities, while maintaining control under the unifying Quality System.
Our facilities are supported by bulk liquid nitrogen supply, monitored by remote alarms, and equipment undergoes daily quality control and appropriate preventive maintenance.
Distribution & Delivery
We understand why delivery is integral to the commercial success of your cell therapy.
It affects clinical development:
- Delivery consistency directly affects product consistency, which has a significant impact on the quality of the clinical data describing product safety and efficacy.
- Delivery procedures requiring significant resources at the clinical site make it harder to engage clinicians and accrue patients in your trials.
It affects commercialization economics:
- Quality of the clinical data directly affects development timelines, resource requirements, and ability to fund the development efforts.
- Impractical delivery procedures challenge the commercial product acceptance by the clinicians, and the patients.
- Demanding delivery resources increases the overall product cost.
- Cost affects healthcare acceptance and reimbursement.
- Completely secure point-to-point chain of control and custody
- Standard operating procedures in all phases of transit
- Highly specialized and trained air and ground courier network
- Quality assurance at each transfer point
- Ideally, full real-time package tracking.
From the beginning, we focus on developing a delivery method that includes all the biological parameters, quality controls, and standardized procedures to ensure efficient and successful delivery of your products in a clinical and commercial setting.
We have established a distribution network capable of handling your cellular materials from collection through manufacturing and delivery back to the patient. We have long-standing relationships with many major commercial carriers, as well as a specialty air carrier with a fleet of over 130 aircrafts serving over 100 cities nationwide to meet all of your distribution needs. This carrier specializes in shipping medical products, including whole blood and blood products, tissues for transplantation, and cryogenically preserved specimens and biologics.