Accelerated Delivery of Phase I Clinical Trial Materials
Just four months, with the Quick to Clinic™ program that's how fast you can formulate a solid dose molecule into a finished drug product and get your clinical trial material for First Time in Human (Phase I) studies.
Utilizing Patheon's network of specialized facilities throughout North America and Europe, the Quick to Clinic™ program assures delivery of finished drug product within four months from receipt of API. These early-phase development centers will provide responsive and flexible service to customers who are under pressure to screen product ideas and make proof of concept decisions quickly.
Fast, flexible, proven.
- Delivery within four months from receipt of API
Specialized early phase development centers
- Global network
- No scheduling competition with late phase projects
Simple, fit-for-purpose formulations
- Blend in capsule
- API in bottle
- API in capsule
- Tablet
- Blend in bottle
- Oral solution
Quick to Clinic enables you to start projects quickly, achieve faster clinical results, and make faster proof of concept decisions, all while minimizing the use of costly API material. With a fixed price and timeline, Quick to Clinic is the smart way to keep your project moving forward.
Case Study: Quick to Clinic™ – Release of Clinical Batches in Only Seven Weeks
The Challenge The customer came to Patheon needing 50 mg capsules of neat API for Phase 1 clinical trials.
The Solution First we validated their assay and dissolution methods. Then we manufactured a prototype batch, which we subjected to a one-month stability test to confirm the suitability of the approach. Disposable manufacturing equipment was employed to eliminate the requirement for cleaning verification.
The Outcome The clinical batches were manufactured and released in just seven weeks – including a 4-week stability test.