A US based biotech organisation required assistance in overseeing the development of a process for a live attenuated viral vaccine that was suitable for phase I clinical trials. The company required the process to be scalable so that the process could be optimised and then scaled suitably for phase II and phase III clinical trials. In addition, the company wish to have the in-process sample testing and bulk drug substance and drug product assays qualified for phase I.
Click here to read the client’s comments about GRA.
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