Doc Logic, absolutely, any change has to be thoroughly adjudicated via their change control system, to include expected results, pilot batch results and then commercial batch results, all the while explaining why and how the change is limited to the expected results and then monitoring results to ensure it is so and nothing more. Closing the system can reduce the risk of sterility failure (quality improvement) by reducing handling and environmental exposure and it can improve operating efficiency. Implementing TFF can improve operating efficiency via time and material savings (improved batch yield). If there are other concurrent benefits either directly from the increased process automation or via additional process enhancements concurrently implemented it gets more complex with additional work and whenever there are multiple changes there is a geometric expansion of the possibilities to carefully manage. All must be explained, piloted, tested, validated,... And, across multiple sites and countries is a challenge as I have said before (sorry to repeat). Confirmatory testing (part of the validation process) is designed as part of the implementation and can include both in plant tests (typical) and in animal tests or in human monitoring for a specified period of time or patients as well. Of course this is all quality and regulatory compliance related and totally separate from the patent process discussed on the board. There could be hiccups to the implementation which could cause interruption to clinical product supply. But there would typically not be an official screening halt unless there was a longer term interruption expected and then the company would have to inform.
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