With the experience of nearly 400 highly potent compounds, you can count on Patheon for the development and manufacturing of these complex pharmaceuticals, including hormones and compounds with Occupational Exposure Limits (OEL) in the nano gram per cubic meter range.
Patheon will keep your project moving forward, even in one the most stringently regulated categories in the industry. Our facilities routinely pass regulatory inspections as well as customer audits. In fact, with more than 133 regulatory inspections since 2007, 31 resulted in zero observations. This stellar track record is proof of our ability to keep pace with ever evolving regulations, and our commitment to constant improvement.
Patheon’s global network of facilities utilize suites that offer fully integrated development, scale-up, and commercial manufacturing in a single site. Our Pharmaceutical Development Services (PDS) scientists are experts in formulation, Clinical Trial Materials (CTM) manufacturing, and scale-up of high-potency products, with the support of comprehensive in-house analytical services. Special features of these facilities include:
- Highly trained and experienced personnel
- World-class medical surveillance program
- World-class handling protocols
- Comprehensive risk assessment processes
- Specially designed facility enhancements, including containment at source
Customers with highly potent compounds enjoy the same flexibility, quality, expertise, and breadth of resources as all Patheon customers, including a broad range of solid and sterile dosage forms:
- Fast-dissolve tablets and capsules
- Immediate-release tablets and capsules
- Controlled-release tablets and capsules
- Liquid-filled hard capsules
- Lyophilized vials
Case Study: Expertise and Comprehensive Resources for High-Potency Drugs
The Challenge A U.S.-based biotechnology company approached Patheon to develop a high-potency small-molecule drug candidate for Phase I clinical studies, and potentially advance the project through to commercial manufacture when approved. The customer had very limited experience and no in-house capabilities for this type of project.
The Solution With an expert team and specialized scientific resources already in place, we began developing the customer’s clinical trial materials almost immediately. We performed the entire clinical development process (providing comprehensive formulation services backed with analytical and project support) all the way through commercialization, all at one site.
The Outcome In less than five years from our first involvement at the preclinical stage, the customer was able to commercially launch their new product from our integrated manufacturing facility – surpassing their expectations. The relationship continues with the development and manufacture of two additional high-potency compounds.