Cell Therapies delivers a cost effective and fully integrated support infrastructure for clinical trials. Our services include design and approval, recruitment of principal investigators and patients, licensed manufacture, audit compliance, clinical interpretation and reporting. We are experienced at protocol development, writing of Standard Operating Procedures (SOPs), driving through ethical approvals and, matching of research imperatives to licensed production restraints. The early involvement of research nurses, specialist cryogenic scientists and dedicated apheresis professionals early in the process can underpin a successful trial program.

Peter Mac's CBCT has a ‘Translational Research’ focus for its own research activities. This emphasis provides a balance for the competitive requirements of commercial, clinical and research outcomes. We believe the translation of fundamental research to the clinic and the feedback of outcomes to the researcher is a fundamental requirement for the adoption of cellular therapies into clinical practice.

Although cellular products such as autologous cultured chondrocytes and cultured epidermal autografts are approved for commercial use, the recent events surrounding the controversies of gene therapy highlight the unpredictable nature of the CT. We elected to design and construct a facility that would remain as “generic“ as possible, to enable adaptation to potential future demands of CT. This design meets the technical and regulatory demands required to sustain cells in short- and long-term culture (process cleanroom) as well as meeting the sometimes conflicting requirements for gene transduction protocols (process cleanroom, containment).

Because of our own long-term research objectives, we also incorporated more specialized equipment, such as a high-speed cell sorter for rare target cell isolation, within the cleanroom environment. We anticipated that regulatory authorities would require that cGMP standards (or close equivalents) be applied across the whole spectrum of the cell manipulation process, including acquisition of the starting cell population (e.g., apheresis), cellular isolation, processing, and storage.

Thus, we formed an umbrella organization — the Centre for Blood Cell Therapies (CBCT) — that would possess a GMP license covering all the relevant aspects of cell processing. The quality system (QS) was designed with platform generic standard operating procedures (SOP) that could be modified or added to for specific processes to be performed within the CPC.