We fulfill all of your apheresis needs conveniently, when you need them. Experienced, qualified and specialized staff serving your adult and pediatric patient populations and meeting your research needs. Available through scheduled or emergency procedures in our locations throughout the US or in your institution. Our staff provides you with all equipment and supplies or can utilize your equipment at your site. Expert medical staff available for consultation. We maintain FACT accreditation.
Current Good Manufacturing Practice (cGMP)
Contract Manufacturing Laboratories and Regenerative Medicine Institute provide tissue processing, manipulation, and product manufacturing for research and therapeutic use. The 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. Utilizing this expertise, 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.
Research protocols require high quality disease specific tissues. Our laboratory has extensive experience maintaining large inventory of cryopreserved mononuclear cells, granulocytes, plasma, and platelets for research. Our liquid nitrogen vapor freezers are continuously monitored electronically providing security for irreplaceable patient donated tissues. We can receive, process, catalogue, store, and distribute tissues to laboratories world-wide. We are available to consult and develop procedures with your investigators.
When conducting projects and studies, CCS utilizes its broad expertise and extensive infrastructure, which includes our blood operations, translational center, medical programs and services, and a growing network of collaborating blood and research centers across the country. These resources and background allow us to execute projects and studies with extensive attention to detail and, exceptional quality to national and international locations.