Contract Manufacturing Laboratories provide tissue processing, manipulation, and product manufacturing for research and therapeutic use. The CCS laboratory has processed, cryopreserved, and stored more than 15,000 hematopoietic progenitor cell (HPC) products, mononuclear cells for donor lymphocyte infusions and autologous parathyroid tissue, and provided research tissue banking services.
CCS PhDs and MDs are leaders in transfusion medicine, cellular therapy, immunology and epidemiology, and have designed, reviewed and overseen hundreds of research projects, preclinical and clinical studies. With this background, we will assist your research and development project or study, provide consultation on FDA requirements, certification and 510(K) application, as well as advise and direct regarding technical performance, improvements and adaptations to meet and exceed FDA certification requirements.
For organizations further along in planning and clinical development, CCS will review your protocols for scientific accuracy, feasibility, and design in order to maximize trial viability and validity. We operate Class 10,000/ISO 7 clean rooms, which are used to perform contract manufacturing of cGMP cellular and immunotherapy products.
Interested in our cGMP services? Contact us below and a team member will follow-up promptly.