Accelerated Manufacturing Case Study
CASE STUDY: Accelerated Manufacturing Programme at ARCINOVA
A strategy of rapid clinical progression – dose determination to manufacture and to patient administration within 4 days, necessitating a timeline of dose determination to shipping of product to the remote clinical site within 48 hours - repeated for escalating clinical dose levels.
Japanese Big-Pharma Corporation.
Standard manufacturing procedures replaced with project specific procedures, managed through change control, enabling timelines for dose determination/manufacturing order approval to shipment to the clinic to be reduced from 2 -3 weeks to 48 hours.