While PCT is not at liberty to discuss many of our client relationships or the nature of our work for clients, we have developed a few case studies based on completed projects and services performed . Watch for more case studies to be posted soon.

Click on the study titles below for each of the full case studies in PDF.

Infrastructure Case Study

Abstract: In late 2005, the client identified an imminent requirement for new controlled environment room (CER) space and GMP infrastructure for cell isolation and cell culture expansion of stem cells to create production cell banks and manufacture allogeneic stem cell products for clinical trials commencing in 2006. Within a few weeks of contract signing, PCT used its integrated solutions approach to collaborate with the client and position them to rapidly advance their clinical trial program. PCT provided high quality GMP facilities and infrastructure, providing the client with an excellent return on investment (ROI) with no dilution or distraction of their internal staff and resources.

Quality Systems Implementation Case Study

Abstract: Client considered accreditation by an international, government sponsored organization to be an urgent mission critical business objective. However, in a voluntary audit, 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: 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, 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 after contract signing, PCT:

• Identified four (4) 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
• Compiled and executed a protocol to demonstrate the effective clearance of residual cytokines and FBS by the final wash step
• Provided client with final reports detailing the above development, qualification and clearance studies that were submitted directly to FDA as part of their CMC package

Using an integrated solutions approach, PCT leveraged its significant experience to enable the client to cost-effectively maintain their timeline, initiate their clinical trial and meet their subsequent financing goal.

Strategic Evaluation & Technology Assessment Case Study

Abstract: A client consortium of board member investors financing an early-stage biotechnology company developing a cell-based therapy for tissue regeneration applications, required an independent review of the company structure, overall technology, market opportunity, product development strategy and the route to commercialization. PCT adopted a multi-disciplinary approach to evaluate all aspects of the company’s current operations along with future strategic and operational plans. The evaluation was compiled into a final report incorporating an assessment of risks and specific recommendations for areas of focus/improvement. PCT’s independent assessment and final report enabled the investors to make an informed board level decision regarding the company’s future and strategic plans for developing and commercializing the product, including future fundraising schedules.