Better Technical Transfer for Steriles

Rapid, Cost-Effective Technical Transfer of cGMP Manufacturing Processes to Produce Sterile Clinical Trial Materials

Authors: J.J. Luo, PhD, Brian N. Woodrow, PhD, Craig Davies-Cutting, PhD, Wally Brisson, MBA, Dan Wendt, PhD, Catalent

Pharmaceutical and biopharmaceutical companies are seeking to outsource clinical supplies as few have the capital to build a cGMP compliant aseptic facilities and the expertise to manufacture supplies. Even when they do, often neither the formulation nor the process is adequately developed, resulting in budget overages and timeline delays. In this study a non-sterile, non-GMP laboratory batch was performed using materials equivalent to those released for cGMP batch production to verify or optimize the formulation, to develop a process for use in cGMP manufacturing, to qualify a prefiltration bioburden method, and to evaluate compatibility of formulations with product contact components.

Conclusion: This rapid technical transfer model for cGMP manufacturing resulted in reduced operating costs while accelerating decision-making and facilitating drug product delivery to the clinic.