Scalable apheresis management systems to support your clinical and commercial programs.
We understand that an optimized apheresis management system is essential to clinical trial recruitment and commercial program success.
We have over 18 years’ experience managing apheresis collections under GMP conditions applicable to worldwide programs. We have developed the clinical protocols, process controls, documentation, training, and quality systems to ensure apheresis collections meet Australian and global regulatory expectations.
Our approach is captured in 5 different modules and these can be implemented collectively or separately depending on the needs of the clients’ program.
Cell Therapies has extensive experience in the development and commercialization of cell and gene therapies for the Australian and global markets.
We provide rapid technology transfer, process development, manufacturing optimization, clinical trial and commercial product supply to global markets
We manufacture products for clinical trial, provide process development for programs, manage product storage, and supply logistics and distribution
Our experts advise on Chemistry, Manufacturing, and Control (CMC), Australian and international regulatory standards and requirements, and clinical program development
