High Potency ProductsSource: Patheon Inc.
Patheon is the leading publicly listed provider of drug development and manufacturing services to global pharmaceutical, biotechnology and specialty pharmaceutical companies.
With the experience of more than 150 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 108 regulatory inspections since 2006, 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