Welcome to the 2nd segment of our blog series on what impacts cell therapy starting material quality. This week, we examine what comprises apheresis best practices, which are critical to the quality of apheresis materials.
Quality material starts with a strong donor network, and good donor management is vital to establishing and maintaining that network. Physiology aside, a good donor is one who is reliable, responsive, and well-informed. Active outreach to donors and maintaining strong, positive relationships, can make or break a network. Donors who have had a positive experience are more likely to be open to repeat donation, which in turn increases the chances of finding the “right” donor for a client in a timely manner.
Age, weight, stress, fatigue—all of these factors and more can impact donor physiology and introduce variability into apheresis collection. With so many different factors to balance, expertise in donor management is crucial. Apheresis center staff must make decisions on whether a candidate is healthy enough to donate on a given day; they need to be mindful of a donor’s comfort and safety, as well as capable of dealing quickly and professionally with any unexpected issues.
Expert familiarity with apheresis equipment and protocols is also extremely important. The length of time a donor can comfortably tolerate being hooked up to an apheresis device may differ from person to person. Additionally, venous access methods may differ due to body size and vascular anatomy. Apheresis nurses need to be skillful and experienced with prepping the donor for withdrawal and re-infusion of blood components, with minimal risk of contamination or error. They also need to be highly trained so that they can calculate optimal cell collection rates and volumes that are safe for the patient while maximizing collection yield and purity and be proficient at operating the apheresis instrumentation so that they can adjust run parameters as needed during collection.
Apheresis is an art and apheresis nurses must possess the following attributes to ensure successful collections:
Resources and procedural considerations also come into play. Access to the latest leukapheresis equipment and sample separation technologies can help optimize collection efficiency and cell isolation. Collection efficiency is quantified by the number of target cells in a given apheresis unit. Starting material suppliers need to be mindful of that higher collection yields do not necessarily equate to high-quality starting materials. A high-quality product balances total yield with higher purity in terms of healthy target cells.
Once collection is complete, cell therapy starting materials need to be correctly labeled and documented and accurately link donor information to the collected material. In some cases, post-collection processing steps such as washing and volume reduction, cell type isolation, and cryopreservation will be carried out at the collection center. These steps must be optimized to preserve maximum viability, purity, and functionality of the collected material. Care must be taken to ensure shipping and handling procedures do not damage the viability of the starting material. Even the highest quality starting material will lose functionality if the product is exposed to unexpected temperature fluctuations, improper packaging, or shipping delays.
In short, every cell therapy starting material collection should be closely managed by an apheresis expert throughout processing. This will ensure that the optimal balance of product purity and yield is realized and that the integrity of the product is safeguarded until it reaches the client.
Please join us for the next segment of our series, as we examine what ultimately defines a high-quality product.