Last week, HemaCare published an article in Technology Networks discussing how optimal apheresis and collection methods give cell therapies a leading edge1
Cell therapy is a unique field because the “products” are derived from living human cells and where each donor is different, variability is inevitable. Quality precursor material gives cell therapy products their best start. Variable or low-quality starting material introduces a need for complex separation strategies or repeated manufacturing runs, leading to higher costs and resource requirements.1 To ensure the process utilizes the right resources, scientists must adopt optimal apheresis instrumentation and collection methods as one of the most important steps.
Optimized apheresis collection starts with the donor, and access to a reliable donor pool is a must. A large, diverse, and well-organized pool of recallable donors means there will be a greater chance of finding just the right donor or donors within a satisfactory time frame.2 However, more than that is needed to guarantee superior quality starting material.
Collection methods affect product consistency
There are many leukapheresis systems available on the market today and each system includes different capabilities.3 The specific type of system a clinic uses will depend on a number of considerations including;
- Preferred flow rate
- Volume capacity
- Process flexibility
- Software capabilities
However, cost is also a major consideration as not all clinics or pharmaceutical manufacturers can afford the most complex equipment or data platforms.
Many variables can play into the quality and quantity of cells that can be collected and standardization of both leukapheresis instrumentation and operator training across cell therapy starting material collection sites is important. In a best-case scenario, apheresis nurses will be highly trained and experienced, with excellent venipuncture skills and comforting bedside manner. Tight coordination of cell collection sites and processing labs is required to preserve the viability and functionality of therapeutic cell types.1 Once the leukapheresis unit (leukopak) is collected, the therapeutic potency of the cells must be protected until the unit can reach the processing facility.
As more and more cell-based therapies are validated and approved for the clinic, apheresis derived starting material will increasingly impact the practice of medicine. Using best practices when determining instrumentation and collection methods will ensure that these important therapies begin with the optimal material quality.
- Dominic Clarke, PhD and Marie Aragon, RN, BSN. Optimizing Starting Material Quality for Cellular Therapeutics. Technology Networks. August 2018
- Juliano L, et al. The Importance of Collection, Processing and Biopreservation Best Practices in Determining CAR-T Starting Material Quality. Cell and Gene Therapy Insights. 327-336. 2018
- Kim J, et al.Comparison of Spectra Optia and COBE Spectra apheresis systems' performances for red blood cell exchange procedures. Transfusion and Apheresis Science. 55 (3) 368-370. December 2016.