Patheon Inc. > Services > Development Services (PDS)

What types of products does Patheon develop for its clients?
Patheon develops a full range of product types across most therapeutic indications. We can develop and commercialize products in most dosage forms including solids, semi-solids, liquids and steriles extending to specialized forms such as liquid-filled hard capsules, controlled release formulations and lyophilized products.

What experience do Patheon scientists offer?
Patheon has approximately 600 development scientists and support staff, including more than 75 PhD’s. Our Pharmaceutical Development Services (PDS) scientists bring years of extensive experience and expertise to virtually all types of drug development projects. Patheon’s PDS scientists are working on more than 300 development projects in all phases of clinical development and across a full range of molecules and dosage forms.

Where are Patheon’s Development Centers located?
Patheon offers integrated development services from development centers in North America and Europe. Many of our development centers are integrated with our commercial manufacturing operations. This integrated approach allows our development scientists to work closely with operations to develop and commercialize customer products quickly and efficiently all in one site. Our Pharmaceutical Development Services are available at:

Does Patheon offer any specialized development services or capabilities?
Patheon‘s strategy is to be a leader in outsourced pharmaceutical development services. We continue to add new services and technologies in line with the evolving demands of the industry and to meet the changing needs of our customers.
Some of our specialized development services include:

Clinical Packaging
Liquid-filled hard capsule capabilities
Sterile development of small and large volume parenterals
Advanced aseptic disposable technologies for all contact points
Lyophilization services
High-potency capabilities
Controlled/sustained release capabilities
Nasal spray development or reformulation
Quick to Clinic™ programs focused on accelerating early phase development and using minimal amounts of API

Does Patheon offer proprietary drug delivery technologies?
Although Patheon does not own any proprietary drug delivery systems, we are always looking for ways to offer our customers drug delivery options which may include non-proprietary approaches as well as those available through strategic alliances. For example, Patheon is currently partnered with Depomed and can offer their AcuForm™ modified release technology in combination with our extensive controlled release formulation experience. Patheon’s extensive formulation experience and capabilities combined with Depomed’s AcuForm™ controlled release technology serve as an example of Patheon’s effort to provide our customers with solutions to their formulation challenges.

Does Patheon sell formulations?
Patheon does not sell formulations. We develop formulations exclusively for our customers and we do not own any products of our own.

Who does Patheon develop products for?
Patheon develops products for a varying range of customer types including pharmaceutical, biotechnology and specialty pharmaceutical companies. With 270 customers globally, we have experience in serving the smallest start-up biotechnology company to the world’s largest pharmaceutical companies. We understand each customer’s needs and can structure a flexible development plan that will meet their timelines and budgetary requirements.

Click on Our Customers for more information about who we service.

When can Patheon assist with my development project?
Patheon offers development services ranging from the earliest pre-formulation services through the entire clinical development process, including formulation development, clinical trials manufacturing, analytical development and eventually scale up in almost all batch sizes. We offer scalable equipment to meet our customers' needs in most of these areas including miniaturization equipment for development using minimal amounts of API. Products developed by Patheon are designed to be easily scaled to full commercial manufacturing.

What are the next steps for my development project?
Patheon first requires the completion of a Customer Disclosure Agreement (CDA) to protect the intellectual property of your product. We also perform a technical assessment in order to accurately determine your specific project needs.
If you would like to speak with a representative about your project and how we can help, please complete the Contact Us form and one of our representatives will promptly contact you.

Can Patheon assist us with our clinical trials?
Patheon provides dosage form development and small-scale manufacturing and packaging services for clinical trial programs. Our clinical trials materials are fully supported with analytical methods and stability studies. We can also offer over-encapsulation which is often used for blinding in clinical trials. Our expertise lies in the development, manufacturing and packaging of the drug - regardless of the scale of the project. Our Quick to Clinic™ programs apply a variety of tools and development strategies and can help accelerate your early phase development project to clinical studies using minimal amounts of API. Patheon also offers full clinical packaging and distribution services for all clinical trial phases globally.

Can you do the NDA filing of my drug product?
Patheon provides comprehensive support services for NDA filing, including providing extensive documentation for the Chemistry & Manufacturing Controls (CMC) section of the filing. Patheon does not, however, prepare, write or submit the NDA filing.

To what level does Patheon support the regulatory filing or registration of new drug products?
Patheon has helped launch more than 19 new products since 2001 for a variety of customers with regulatory requirements in international markets. Patheon’s Pharmaceutical Development Services (PDS) scientists provide data in NDA-ready format to facilitate customers with the application or registration of their new drug product.

Patheon also offers customers the benefit of our extensive experience with pre-approval inspections (PAIs) having had more than 35 PAIs since 2000 in addition to more than 20 waivers as a result of our strong compliance record.

As API costs increase, what is Patheon doing to save customers’ costs?
Patheon offers Quick to Clinic™ programs which apply a variety of tools and development strategies to rapidly bring new molecules to clinic using reduced amounts of your valuable API.

Does Patheon offer lifecycle enhancement services?
We work closely with our customers to ensure that our integrated and highly scalable development services meet our customer’s needs throughout their product’s lifecycle. From early phase development to offering reformulation or combination product strategies, Patheon offers a great deal of scientific expertise to extend the competitive life of mature products.