Background The use of cord blood (CB) serum as a tear substitute has been recently proposed to heal severe corneal epithelial damage due to its high concentration of epithelial growth factors. No branded CB serum-based eye drops are available on the market.
Purpose To optimise the preparation of experimental galenical CB serum-based eye drops by ensuring product safety.
Material and methods In S. Orsola-Malpighi Hospital of Bologna, Italy, the drops were made under a vertical laminar flow hood. In the Transfusion Centre serum was collected from CB units, centrifuged for 10 min at 3,500 rpm, aliquoted into 15 ml sterile tubes and frozen at -80°C for six months as a quarantine period. Serological and molecular tests were performed on each serum sample, according to the Italian regulations. Thawed CB serum was sent to the pharmacy laboratory where it was diluted 1:5 with refrigerated sterile physiological saline, filtered (Millex HV 0.45 μm) and aliquoted into 1 ml single-dose PET vials. Filled vials were thermo-welded and packed in sealed labelled envelopes. Finally, they were stored at −20°C for 30 days before delivery to patients. Certification of molecular and serological tests was retained in the pharmacy. CB serum levels of epithelial growth factors were tested at different steps: freshly collected, thawed after quarantine, after filtration, after dilution and after one or two months storage at −20°C, respectively. Sterility was validated by a BacT/Alert test on each batch of eye drops.
Results Sterility tests confirmed that all batches of eye drops remained sterile after handling and storage. Immunological tests showed that CB serum levels were maintained over the whole process. Patients must keep the eye drops refrigerated and use them within 12 days.
Conclusion The collaboration among interdisciplinary professional figures overcame critical preparation problems, providing patients with a safe and effective product.
References and/or acknowledgements No conflict of interest.
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