Challenges in manufacturing an amniotic membrane alternative for corneal regeneration

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The current and projected worldwide cornea shortages have acted as a driver for the development of feasible, long-term alternatives to cadaveric donor tissue. Alternatives in current clinical or pre-clinical development can be loosely categorised into the following broad areas: keratoprostheses, tissue engineered constructs, xenografts and the use of decellularized/acellular matrices. With respect to corneal regeneration, there are many challenges to address, not least that the corneal structure is unique and difficult to replicate. When manufacturing corneal tissues, the choice of material is a vital consideration as the list of requirements is extensive. They must be biocompatible, (preferably) optically transparent, flexible, and strong, as to withstand manipulation in culture, potential suturing, irrigation and handling during surgery. Furthermore, the manufacturing process needs to be simple with consistent quality, preferably at high speed and low cost. The biodegradability or bioreasorbability of the construct needs consideration to ensure cellular integration, regeneration and reconstruction. Two fundamental objectives concerning corneal regeneration are the maintenance of healthy cell phenotypes either in vitro or in vivo following implantation; and the replication of the native tissue architecture. If both factors are not satisfied, the result is often regenerated tissue mimicking that of scarred native tissue.

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