Objectives: To create a low-cost protocol for the production of autologous serum eye drops (ASEs) by blood collection and processing centres using standard equipment and staff already available. The protocol must observe local and federal regulatory authorities' requirements for good manufacturing practice.
Aim: The final aim is to improve accessibility to ASEs for patients who need them and to implement similar production parameters at all institutions producing ASEs.
Background: Despite evidence of the beneficial effects of ASEs in the treatment of severe ocular surface diseases, ASEs are not approved by most federal regulatory bodies in the United States or Europe. In some countries, such as the United States, access to ASEs is extremely limited and cost-prohibitive. Blood processing centres are in optimal position to help in increasing accessibility and lowering the cost of these products.
Materials/methods: Standard blood processing equipment, staff and materials were chosen for the protocol. The protocol was designed to minimise the risk of contamination as much as possible.
Results: A low-cost, open system protocol for production of ASEs was generated that can be implemented by most blood collection and processing centres in the United States and Europe.
Conclusion: Efforts should be made to propagate a similar protocol for the production of ASEs in blood centres capable of collecting and processing blood products, making this service affordable and uniformly accessible to patients.
© 2011 The Authors. Transfusion Medicine © 2011 British Blood Transfusion Society.