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Our work and case studies

Challenge: 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.

Customer:

Japanese Big-Pharma Corporation.

Outcome:

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. 

 

Accelerated Manufacturing 48 HRS slide

Accelerated Manufacturing 21 Days slide