OVERVIEW

• Pharmaceutical Development Services Area: 8,500 ft2
• Regulatory Approval:
• HPFBI (Canada)
• U.S. FDA                         
• German Health Authority

PDS Whitby is based at Patheon’s Whitby Region Operations, Canada, and offers development services for conventional solid and liquid dosage forms. PDS scientists at the facility are also experienced in the development of low solubility compounds, pediatric products, controlled release and multilayer tablets.

The development group provides clients with access to formulation development, process development, CTM manufacturing, and scale-up services for a range of product types. From pre-clinical through to scale-up and registration, PDS Canada can meet your development needs. All development services are fully supported with comprehensive analytical testing, including customized ICH stability programs.

Patheon Whitby is a Quick to Clinic™ center of excellence providing rapid turnaround for developing products for Phase I (First Time In Human) clinical studies.

Patheon Whitby offers analytical support and development for solid and liquid products including:

• Capsules
• Coated tablets
• Multilayer tablets
• Low solubility compounds
• Complex liquids (including experience with microfluidization)
• Line Extension and Pediatric product development

Services

• Analytical Development
• Formulation Development
• Quick to Clinic™ for First Time in Human (Phase I) studies
• Clinical Trial Manufacturing for Phases I-III
• Low solubility compound development
• Process design and scale up
• Stability testing
• Lifecycle product development

Development capabilities at PDS Whitby Canada are fully integrated with scale-up and commercial manufacturing at the same site. Please click on the Commercial icon above to learn more about commercial capabilities at Whitby Region Operations.