Consulting and Advisory

Cell Therapies’ technical experts can evaluate your target product candidate and its associated development approach.  Our experience with multiple cell therapy programs throughout the development lifecycle to commercialization provides unique perspective that can benefit your program’s strategy.

Cell Therapies have substantial GMP manufacturing process development and optimization expertise for clinical trial and high-throughput commercial supply. This is supported by our GMP license from the Therapeutic Goods Administration (TGA) and accreditation by the Japanese Ministry of Health Labour and Welfare (MHLW). We also comply with the international Pharmaceutical Inspection Co-operation Scheme (PIC/S), along with various local, regional, and international standards.

• Technical feasibility assessments for pre-clinical programs to guide development activities and prepare for clinical trials.
• In-depth cost analysis to determine targeted product costs.
• Donor collection network assessments to enable control of critical starting material such as apheresis.
• Manufacturing and hospital facility gap assessments to provide recommendations to meet regulatory requirements for clinical trial supply.
• Implementation of custom GMP training programs to impart best practices in cell therapy manufacturing.

Quality as a service, including support for health services such as clinical apheresis and cryopreservation