The regenerative medicine field is full of small firms working on innovative therapies that hold great promise for medical treatments or cures for serious diseases. However these firms often lack expertise and resources to transfer from limited lab-based prototypes to manufacturing systems that can reliably produce clinically effective products. Use of standard methods and materials can assist these firms in the transition.
Standardized methods for characterization of regenerative medicine products, standardized information on source and ancillary materials and standardized assays for sterility testing are a few examples of areas in which standards can assist firms in developing regenerative medicine products that can meet regulatory expectations.
Efforts to fully take advantage of the potential benefits of standards in manufacturing regenerative medicine are currently hampered by a lack of standards in this emerging field. ARMI works with its members to identify common challenges across the field, which are gaps that standards could fill. It then works with them to not only develop such standards but also promote their use.