Characteristics in Manufacturing Autologous Serum Eye Drops

For special cases of "dry eye" due to ocular surface disorders, conventional therapy with commercial eye drops or sclerallenses, is not sufficient. Autologous serum eye drops, ASED, can ameliorate refractory keratoconjunctivitis sicca, persistent epithelial defects (PED), erosiones corneae and/or neurothrophic keratopathies, through its epithelotrophic capacity. Manufacturing using the new closed system is substantially simpler and safer. Delivery to the patient via a pharmacy, which is required by German law, represents a continuous logistic challenge. This article is presenting the experiences by the validation and manufacturing in the first 2 years. ASED have been manufactured by the majority of the patients in "closed" systems using specific whole blood collection systems (TF 304KK, Medizintechnik Meise GmbH, Schalksmfihle, Germany) and only in exceptional cases (difficult veins status), using 9 ml gel -serum monovette tubes (collection volume of 120-150 ml), in "open" system in the GMP (clean zone) laboratory. All patients returning to further blood donations reported an improvement of their clinical symptoms under ASED therapy. The initiation of ASED manufacturing requested complexorganisational work: after manufacturing the pharmaceutical product, logistic of delivery (through each patients pharmacy, due to German regulations), had to be planned, validated and established, as well. Some products were lost due to defects of cooling systems in these pharmacies. Changes of the German pharmaceutical law are urgently required in order to optimise the actual logistic and accounting, consequently making possible the ASED delivery directly from the manufacturer to the patients.