The Role of Cellular Therapy Apheresis Collections for Your Clinical Trials
Apheresis is a technique to separate whole blood into its component parts (plasma, red cells, white cells, and platelets) to isolate certain ones for removal and return the remaining components to the patient for therapeutic or donor reasons. In the case of donor apheresis, also known as cellular therapy apheresis, these cells are collected from healthy donors for research, and for patients needing CAR T-cell therapy or bone marrow transplantation. Due to the nature of regenerative medicine and stem-cell research, many if not most clinical trials require cellular therapy apheresis collection. The highly-regulated and ever-changing landscape of these fields virtually requires organizations to outsource this component as it enables them to offer the benefits of cellular therapy without the burdening costs to maintain equipment, supplies, and staff. Most importantly, maintaining performance and quality data for regulatory compliance should left to the experts who can be dedicated to complying with any applicable, institution-specific requirements and standards.
Comprehensive Cell Solutions (CCS), a fast-growing biotechnology division within NYBCe, continues to develop its apheresis program to meet the needs of the ever-changing world of immunotherapy and to also meet its very high regulations. The cellular therapy collection and laboratory service team consists of highly experienced and trained RNs, licensed laboratory technologists, laboratory and medical directors, and managers. Aside from the years of experience in apheresis, CCS differentiates themselves through their accreditations by both AABB and FACT, while also complying to all NYSDOH and FDA regulations.
CCS will work with various types of organizations to develop and implement their cellular therapy goals, whether for standard treatment of research protocol. Additionally, either the service manager or medical director is available 24/7 for further consultation.