The Challenge
A U.S. based biotechnology company approached Patheon in search of a company that could develop a high-potency small molecule drug candidate for upcoming Phase I clinical studies and potentially advance the project through to commercial manufacture if approved. The customer company had very limited experience in the development and launch of this type of small molecule and lacked the capabilities to develop and manufacture it in-house.
The Solution
Patheon was able to utilize its development Center of Excellence for high-potency projects at the Toronto Region Operations (TRO) site to meet the early phase development requirements of this customer. This development facility is able to handle highly potent molecules at all phases of development down to the low nanogram/m3 Occupational Exposure Levels (OELs) limits. This dedicated development facility is integrated with the commercial manufacturing operations at the same site which also specializes in high-potency products. The development team was able to accommodate the customer’s compound in our specialized development facility and began developing their Phase I clinical materials almost immediately.
Patheon’s development team in Toronto worked step by step through the entire clinical development process, providing comprehensive formulation services all backed with analytical and project support. Our team scheduled additional meetings and provided supplementary documentation to our customer to help them through the complex development process for high-potency small molecule formulations which was a new endeavor for them.
Patheon has handled 200 highly potent actives throughout our network since 2000 and was therefore able to dedicate the experienced scientific resources and facilities to advance the high-potency molecule through the development process to commercialization all in one site.
The Outcome
The customer worked closely with Patheon’s experienced development and manufacturing staff throughout the process and was able to commercially launch their new product within five years of Patheon’s first involvement at the preclinical stage. The product was launched from the Toronto site’s integrated manufacturing facility which was approved by the U.S. FDA for the manufacture of this product. The product is produced at this location for the U.S. market as well as other international markets.
Patheon surpassed the customer’s expectations in terms of experience, capabilities and flexibility, and was subsequently chosen to develop and manufacture two additional high-potency compounds for this customer.