Cell therapy research publication RegMedNet has just posted HemaCare’s latest article on how to use apheresis and cell collection techniques to optimize starting material quality. 
An Expansive Donor Network Helps Guarantee Consistent Quality
Apheresis donor material is intrinsically variable, yet a successful cell therapy product must have consistent efficacy across a wide range of patients. How do we reconcile these realities? As a large-scale apheresis supplier, HemaCare understands that quality raw materials are a matter of careful planning and expertise. Inter-donor variability can impact critical parameters including cell collection volume, cell subtype composition and cell proliferation potential.  Each of these parameters impact apheresis unit potency, and can impact resource use and manufacturing efficiency.
“Since cell therapy products are intrinsically variable, commercial scale-up or scale-out is challenging. Maintaining product consistency across multiple processing steps and multiple manufacturing and clinical sites is critical. A study published in 2016 characterized bone marrow-derived human mesenchymal stem cells (MSCs) derived from different donors and found that in spite of the fact that each donated unit was required to meet minimal criteria proposed by the ISCT for MSCs, there were differences in key characteristics, including cell growth potential and IL-6 production.” 
One way to cope with apheresis collection variability is to carefully manage the network of available donors. Extensive donor pre-qualification, screening, and characterization all help develop a network of donors with the necessary apheresis quality criteria. Good communication and a positive relationship also help encourage donors to be amenable to repeat collection.
“It is telling that HemaCare has provided leukapheresis process development material for 100% of the currently FDA-approved immunocellular therapies, Kymriah®, Yescarta® and Provenge®. Operating the industry’s largest apheresis donor networks that directly supports cell therapy development, HemaCare leverages its 40 years of FDA and cGMP-compliant collection expertise to ensure rigorous starting material quality criteria are met.”
Cell Collection Methods Impact Downstream Potency
Fine-tuning apheresis cell collection methods is another way to optimize quality. Clinicians should discuss which apheresis instrumentation best suits their cell therapy goals, which mobilization method is best for their patient, and the optimal cell collection timing for their target cell type. Apheresis nurses and clinical staff should be highly qualified, and training programs and apheresis methods should be standardized.
Cell purification techniques are also critical. Optimized apheresis material should ideally have high viable cell counts and low contamination rates. Centrifugation strategies used to separate cell types by density can be combined with post-apheresis cell isolation techniques to optimize target cell concentrations.
Perhaps most importantly, quality systems need to be in place to safeguard starting material purity and potency. As more cell therapies reach the commercialization stage, guaranteeing starting material quality is becoming imperative. If you would like more information on how to accomplish this goal, please take a look at HemaCare’s latest publication.
Read the full article here.
- Clarke D., and Aragon M. Optimizing the quality of cell therapy starting materials. RegMedNet. Oct 2018.
- Crisalli LM, Frey NV, Hexner EL et al. Higher Donor Apheresis Blood Volumes Are Associated with Reduced Relapse Risk and Improved Survival in Reduced-Intensity Allogeneic Transplantations with Unrelated Donors. Biol. Blood Marrow Transplant. 24(6): 1203-1208. 2018.
- Heathman TRJ, Rafiq QA, Chan AKC et al. Characterization of human mesenchymal stem cells from multiple donors and the implications for large scale bioprocess development. Biochemical Engineering Journal. 108: 14-23. 2016.