161 - Safety, clinical efficancy, and cost-effectiveness of mononuclear cell collections for autologous immunotherapies: First experience from a private cell collection facility

Background & Aim Within the EU the collection of mononuclear cells (MNC) as starting source for the manufacturing of autologous cell therapies are mainly performed in hospitals or hospital-associated apheresis centers. We report about the challenges to perform the leukapheresis procedure (LA) at a private held medical practice, with specific emphases on safety, cell collection efficiency, and cost-effectiveness. Methods, Results & Conclusion We reviewed the records of altogether 60 outpatients and 100 healthy donors who underwent a total of 220 unstimulated LA procedure at Cyto-Care, a private held medical practice/ certified cell collection facility located in Vienna, Austria. All patients participated in various industry-sponsored clinical P I-III trials; the study sponsors were responsible for the manufacturing of the active cell product. Disease entities were mainly prostatic cancer (75%) and ovarian cancer (20%). Based on differences in the study protocols LA was performed either one-time (41%), two-times (27%) or three-times (32%), with an interval of at least 2 weeks between repeated collections. All patients successfully completed the apheresis course. Because of poor venous access, 3 out of 60 patients (5%) required a short-term femoral catheter insertion. There were no serious side effects in patients who required a femoral catheter, or in patients with repeated LA procedures. Side effects of the LA procedure mainly consisted on mild hypocalcaemia-related symptoms in 16% of patients. A follow-up survey one week after completion of the LA revealed no infectious complications, and no patient required hospitalization. Median cell yield collected per single apheresis was 1.5 × 10e10 WBC consisting of 1.3 × 10e10 MNC. MNC cell yields remained stable even in repeated LA collections. All cell products were successful transformed into an active cellular product. Analysis of the cost structure showed that the total cost of care was 32% lower in the setting of a private collection center compared to hospital-based apheresis centers. Leukapheresis performed in a private medical practice/ certified cell collection facility is safe and effective, with low rates of complications and high levels of patient satisfaction. This service model is cost-effective and can help to reduce the cost of manufactured goods in the production of innovative cellular products.