Case Studies >

We have developed a few case studies to give you real-life examples of what we do best.* Click on the study titles below for each of the full case studies in PDF.

Contact us to learn more about what PCT can do for you.

*At PCT, we place paramount importance on the protection of our Client’s confidentiality and proprietary information, and therefore we only release certain limited statements about our past and current Client relationships and their related projects.

REDUCTION IN COST OF GOODS AND GEOGRAPHIC COVERAGE CASE STUDY

ABSTRACT: The Client approached PCT for a cost-effective and high-quality solution to its manufacturing needs for its vaccine portfolio, including East Coast clinical manufacturing capabilities and assistance in transitioning to its own commercial manufacturing plant in preparation for commercial launch. PCT began manufacturing for the Client’s vaccine portfolio, which included vaccines for multiple indications.  Over eight years, PCT manufactured over 1,200 cell therapy products for the Client, including Phase 1, 2, 3, and 3b trials and BLA submission. The Client estimated that outsourcing its California cell processing operations saved the company millions of dollars.

INNOVATIVE PRODUCT DESIGN MECHANISM AND PACKAGING CASE STUDY

ABSTRACT: Cell therapy products that must be processed by PCT and returned to clinical site within a tight timeframe required a protective shipping case that protects the products from possible rough handling situations in transit under varying conditions. The shipping container had to maintain a constant internal temperature range of 1-10° C for 24 hours and protect product syringes against leakage in transit.  PCT designed a protective container for the Client’s final product to be used for shipment from PCT to the clinical site that included capabilities for temperature maintenance as well as a specialty locking mechanism designed to protect the product syringes from leakage during transit.  PCT also designed an innovative mechanism for product delivery to patient that allows for greatest infusion of cells from product syringe resulting in a maximum product dose being delivered to each patient.

INFRASTRUCTURE CASE STUDY

ABSTRACT: The Client identified an imminent requirement for new controlled environment room (CER) space and cGMP infrastructure for cell isolation and cell culture expansion of stem cells to create production cell banks and manufacture allogeneic stem cell products for upcoming clinical trials. PCT used its integrated solutions approach to collaborate with the Client and help them rapidly advance their clinical trial program. PCT provided high quality cGMP facilities and infrastructure, providing the Client with an excellent return on investment with no dilution or distraction of their internal staff and resources.

QUALITY SYSTEMS IMPLEMENTATION CASE STUDY

ABSTRACT: The Client considered accreditation by an international, government-sponsored organization to be an urgent mission critical business objective. However, in a voluntary audit, the Client was denied accreditation due to non-compliance with required cGMPs. After PCT was retained to design, implement, and train on Quality Systems, a voluntary follow-up audit by the government-sponsored agency was coordinated and managed by PCT on behalf of the Client. PCT subsequently managed the responses to minor observations made by the auditor during the follow-up audit. The Client received the accreditation required for execution of their business in a timely and cost-effective manner.

RESIDUALS CLEARANCE DETECTION CASE STUDY

ABSTRACT: The Client had developed an ex vivo expansion strategy requiring the use of fetal bovine serum (FBS) and a multi-cytokine cocktail to optimize expansion of the target cells. In a pre-IND meeting, the FDA advised the Client that a final wash procedure with demonstrated clearance of residual cytokines and FBS was required to allow release of final product for administration to patients. The Client did not have the internal expertise or equipment to define, develop and qualify suitable assay test methods. In a period of less than 2 months, PCT:

  • Identified four critical molecules representative of the residuals for which FDA had requested clearance data, along with suitably sensitive test methods for their detection.
  • Compiled and executed protocols for the development and qualification of the assay test methods.