Cytogenix goal
It is our goal to make nucleic acid-based drug substance produced using this cell-free method suitable for use in humans for the purpose of testing under the auspices of the Food and Drug Administration. We intend to implement standard operating procedures and maintain compliance with current good manufacturing practice (cGMP) to allow the production of clinical grade material. Benefits provided by the cell-free synthesis from a regulatory agency review and compliance perspective are significant. By beginning with a well-characterized master construct, there is minimal need for cell bank systems (master or working cell banks), thus reducing the risk and amount of documentation, space and cost. Furthermore, methods for cell collection, processing and culture conditions would no longer be necessary and would substantially reduce QA/QC and compliance overhead costs associated with these activities.
