Transregional autologous serum eye drop provision by a large German Red Cross Blood Donation Service.

BACKGROUND The Blood Donation Service West serves North Rhine-Westphalia (NRW), Rhineland-Palatinate (RP), and Saarland, an area of 56,500 km2. In addition to routine red blood cell concentrates, plasma, and platelets, special products are provided. Since 2014, this has included autologous serum eye drops (ASED) for topical use in patients suffering from different illnesses accompanied by dry eye disease. METHODS A volume of 250-525 mL of patient blood was collected into an anticoagulant-free blood bag. Laboratory testing included Hepatitis B/C-, HIV 1/2-, and Lues-serology. Coagulation and centrifugation were followed by leukoreduction. Single-use vials were obtained by filling mini-bag systems using a sterile tube welder. Storage at ≤-20 °C enabled a shelf-life of up to 6 months and 30 days at 4 °C after thawing for shipment. RESULTS Contracts were closed with 15 ophthalmology clinics and medical practices in NRW and RP to supply patients with ASED. The patient pool increased from 19 in 2014 to 46 in 2020, with an average age of 43-55 years. Overall, blood collections almost tripled from 31 to 100 per year, increasing the stock of deliverable single-use vials from 3328 to 13,358. Delivery in a liquid state allowed engagement of 44 pharmacies located in the patient neighborhoods for continuous supply. CONCLUSION Manufacturing in a closed bag system allowed integration into blood bank operations. However, cost-coverage by health insurance remained a case-by-case decision. Allogeneic application as 'just-another-blood-product' could be an aspiration. Yet, conclusive data from large clinical trials are needed for licensed provision in Germany.