OVERVIEW

• Facility area:
  • 366,300 ft²  (34,030 m²)
• Pharmaceutical Development Services area:
  • 17,330 ft²  (1,600 m²)
• Regulatory approval:
  • MHRA (UK)
  • U.S. FDA  
  • ISO 9001:2000
•  Commercial manufacturing services
  • Commercial manufacturing area: 349,000 ft² (32,400 m²)

PDS Swindon offers integrated pharmaceutical development services for conventional, sterile, controlled release, and high-potency products. Our extensive development capabilities include formulation, analytical development, Clinical Trial Materials (CTM) and scale-up manufacturing. A Qualified Person (QP) is available on-site to facilitate the release of clinical trial materials in the EU.

The Swindon Operations development facility includes a formulation development laboratory, a fully equipped analytical development laboratory, and a cGMP pilot plant with high potency suites. PDS Swindon is also a Center of Excellence for bio-pharmaceutical development projects. Experienced PDS scientists utilize specialized equipment to efficiently develop a variety of biopharmaceutical products, including proteins, peptides and monoclonal antibodies (MAbs).

Customers of our PDS Swindon development unit have access to our unique sterile filling line using disposable technologies. The IMA Multifill F97 Series Monobloc line provides a flexible manufacturing platform combined with the ability to utilize disposable components for all product contact points. This includes the use of disposable bags in place of traditional and more costly stainless steel vessels, through the application of disposable aseptic filters and disposable peristaltic pumps. This unique combination of technologies provides our customers with an efficient and scalable filling system able to overcome the challenges posed by many large and small molecule sterile products.

Development capabilities at PDS Swindon are designed to efficiently scale-up development projects through to commercial manufacturing all in one location. Please click on the link above to learn more about commercial capabilities at Swindon Operations.

Patheon also operates an early phase development unit in nearby Oxfordshire. Click here to learn more about PDS Milton Park UK.