Proposal of standardized guidelines for the production and quality control of autologous serum eye drops in Korea: based on a nationwide survey

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Abstract

BACKGROUND:

Autologous serum eye drops (ASEDs) have been used to treat many eye diseases. However, there are no standardized guidelines for the production and quality control (QC) of ASEDs in Korea. Our aim was to propose standardized guidelines for the production and QC of ASEDs.

STUDY DESIGN AND METHODS:

We conducted a nationwide survey consisting of questions regarding the methods used in each hospital for the production and QC of ASEDs. The survey was sent by e-mail to 89 doctors responsible for the blood banks at different hospitals.

RESULTS:

Thirty-two hospitals replied, and 13 hospitals reported using the ASEDs in the treatment of patients with eye diseases. The screening test for patients, amount of blood sampling, type of bottle used for blood collection, details about the production of the eye drops, and storage methods and shelf life of unopened and opened bottles of eye drops varied between hospitals.

CONCLUSION:

Based on an analysis of the survey results and a review of the standard operating procedures and protocols for ASEDs used in Japan, Germany, England and Wales, and the United States, we proposed standardized guidelines for the production and QC of ASEDs in Korea. ASEDs are not cell therapy products in the strictest sense. However, because eye drops are composed of serum isolated from blood and are used in patients, we consider ASEDs to be the basis for cell therapy products. Therefore, ASEDs should be produced and stored according to standardized guidelines based on the Good Manufacturing Practice guidelines.

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