Situation

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.    

GRA Involvement

• To work with and oversee a CMO to oversee and develop and manufacturing process suitable for phase I clinical trials.
• Ensure that assays are suitable and qualified prior to initiation to phase I clinical trials.
• To assist with the setting of suitable product specifications.
• To assist in the writing of and submission of the CMC components of the IND, engaging with and responding to regulatory comments as necessary.

Value Added

• Worked with the CMO to develop a scalable & efficient manufacturing process that has been successful in generating clinical trial material for phase I studies
• Helped guide the setting of specifications for the product.
• Provided review of assay qualification protocols and reports together with data analysis.
• Supported the organisation with their CMC FDA regulatory interactions.
• Provided guidance on the preparation and characterisation of master cell banks and virus seeds.
• Help support investment meetings for fundraising by presenting CMC strategy.

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