Serum eye drops (SED) are an experimental therapy for severe forms of dry eyes, increasingly in use worldwide. SED are only mentioned briefly in the Cross-Sectional Guidelines for Therapy with Blood Components and Plasma Derivatives ("Querschnitts-Leitlinien"). Until now standards for manufacturing have not been defined by German Guidelines, "Richtlinien[RS1] Hämotherapie". In the context of European regulations (SOHO[RS2] ) this will be required.

A small pilot survey was conducted to evaluate manufacturing of SED in Germany in two steps, informal interviews and a formal pilot questionnaire. Data of donation, manufacturing details and side effects observed were evaluated according to this standardized questionnaire.

In different regions of Germany regulatory requirements differed. In contrast to previous surveys serum eye drops [RS1] were not manufactured by departments of ophthalmology but increasingly by or in collaboration with departments of transfusion medicine / blood centers. The majority of manufacturers offer autologous serum eye drops [RS2] only. Few departments also provide allogenous serum eye drops[RS3] . A closed system for single day use, ophthiols, is mostly used for packaging. One center manufactures eye drops in sterile bottles filled in clean room conditions. In the formal pilot survey 6 centers reported results on over 8.500 donations in up to 12 years. Sterile controls are performed from each preparation. In comparison to other methods for manufacturing blood products a larger variability between the manufacturers seems to be the case. No serious adverse event related to the product was observed. In two patients[RS4] , bacterial contaminations during SED use were reported: one associated with longer use than prescribed (>> 24h), one with contamination of one single day use ophthiol with 2 eyelash hairs. In both cases the other single day use ophthiols were tested sterile.

In this large cohort of patients, safety of SED production in more than 10 years could be shown. A detailed survey on manufacturing of serum eye drops [RS1] in a larger group of manufacturers is proposed. This will provide additional support for setting scientific standards for manufacturing, which should then become part of the national guidelines in the context of the European SoHO regulations.

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