Establishing Process Control for the Manufacturing of Corneal Tissues in Clinical Applications

There are approximately 1.5 million cases of corneal blindness diagnosed annually and 10 million untreated patients worldwide. Presently, worldwide shortages of donated corneal tissues warrant the need for alternative engineered solutions. There is also an immediate demand to verify the condition of all donated tissues such that it can be deemed viable for transplantation. Once the initial state has been determined, subsequent processes including transportation, storage and preparations for use, can be examined to determine if at any stage damage is inflicted upon the tissue.

We need to establish robust measures since current protocols lack manufacturing controls necessary to create a reproducible manufacturing process suitable for regular clinical application. This requires the development of novel quantitative characterisation tools to measure primarily the quality of input materials, with the ultimate aim to develop a capability to measure and quantify downstream processing techniques. This will allow for the determination of defined tissue specifications, and a system capable of auditing donor tissue to determine its suitability for transplantation. In order to determine design specifications, an audit of healthy versus non-healthy corneal tissues will be performed in conjunction with Leicester Royal infirmary Hospital.
Such a capability enables tissue-engineering processes to be examined including decellurisation, which has the potential for recycling corneal tissues deemed unsuitable for transplantation as partial thickness grafts. The use of laser speckle interferometric instruments has recently been shown to provide a near instantaneous means of mechanically measuring corneal properties and defining the suitability of corneal tissue. This project seeks to extend this work, establish process controls and examine the potential for diagnosing early onset corneal issues such as keratoconus.