Serum eye drops: a survey of international production methods.
BACKGROUND
Serum eye drops (SEDs) are used to treat dry eye syndrome and non-healing corneal lesions when other treatments fail. Despite many clinical studies demonstrating the efficacy of both autologous and allogeneic SEDs, there is no internationally harmonized method for producing SEDs.


METHODS
A 40-question survey requesting information regarding donor selection, blood collection and processing, infectious disease screening, shelf life and regulatory requirements for the production of autologous and allogeneic SEDs was developed by the Biomedical Excellence for Safer Transfusion Collaborative. Survey data were collected into a database via a secure web interface and then downloaded into Excel for further analysis.


RESULTS
A total of 55 responses were received, with 21 responses from centres indicating they produce SEDs. Based on the responses, collection and processing practices differ widely, according to the size of the centre making the SEDs, and their ability to collect, process and test the blood.


CONCLUSIONS
Despite divergences in the methods for producing SEDs, the end result is a small-volume aliquot of serum that can be administered by a patient at home. If more centres move from producing autologous to allogeneic SEDs, this may provide an opportunity for production methods to become more standardized internationally.
Research and Development, Australian Red Cross Blood Service, Sydney, NSW, Australia.
D C
http://orcid.org/0000-0002-3674-6934
DC
Marks
Department of Product and Process Development, Sanquin Blood Supply, Amsterdam, The Netherlands.
P F
http://orcid.org/0000-0002-2093-3604
PF
van der Meer
D001800:Blood Specimen Collection; D046148:Donor Selection; D015352:Dry Eye Syndromes / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D009883:Ophthalmic Solutions / Q000627:therapeutic use*; D061214:Patient Safety; D044967:Serum; D011795:Surveys and Questionnaires; D013678:Technology, Pharmaceutical / Q000379:methods* / Q000592:standards
D009883:Ophthalmic Solutions
autologous collections; blood components; blood processing; serum eye drops; whole blood