Early-phase development facility
Patheon is one of the largest contract drug development and manufacturing service providers in the world. To meet the increasing demand in the region, Patheon opened an early-phase development facility in Milton Park, Oxfordshire, UK on 10 April 2008.
The facility focuses on the development and formulation of semi-solid, oral liquid and solid dosage forms at the earliest development phases and develops required clinical materials. The facility also manufactures small batches of liquid-filled hard capsules (LFHC), through hand-filling techniques.
Patheon has ten manufacturing facilities and seven development centres across the US, Canada and Europe. With three facilities in the US, three in Canada and four in Europe, Patheon offers more than 300,000m² of capacity.
The company has two pharmaceutical development services (PDS) facilities each in the US, the UK and Canada and one in Italy. The PDS facilities provide integrated services ranging from pre-formulation, formulation, analytical development, scale-up and clinical trial material manufacturing including packaging.
The company employs over 5,300 people. Its customers include Novartis, Sanofi-Aventis, Merck, Roche, Gilead Sciences, Amgen, Medicis and Watson Pharmaceuticals. Patheon has launched about 20 new products for its clients since 2001. The company’s revenue in 2008 was $717.3m.
Milton Park facility
The newly constructed 13,500ft² (1,250m²) facility in Oxfordshire has been leased for PDS. The plant incorporates disposable technologies to accelerate development services. It has fully equipped formulation laboratories, an analytical laboratory and Good Manufacturing Practice (GMP) areas to produce clinical trial materials for Phases I and II.
Patheon’s proprietary Quick to Clinic programme, which minimises active pharmaceutical ingredient (API) requirements and reduces development time of new molecules, is also practised at the Milton Park facility.
The Quick to Clinic programme also has the advantage of rapid distribution of clinical trial materials. The finished drug product is delivered within four months from the receipt of APIs. It is offered at the Milton Park facility in the UK and the Whitby facility in Canada. The facilities are specifically designed for early-phase development and delivery.
The Milton PDS plant holds an Investigational Medical Product License from the UK Medicines and Healthcare products Regulatory Agency (MHRA). The licence is necessary for a pharmaceutical plant in the EU to conduct clinical trials.
In July 2009, the PDS facility underwent cleanroom partitioning to introduce a controlled cleanroom environment with high specifications for testing pharmaceutical products. The cleanroom environment has very low levels of contamination and limits chemical vapour pollutants, airborne microbes, aerosol particles and dust in the measure of particles per cubic metre.
Troax UK provided the Toledo partitioning system, a double-skin cleanroom partitioning system. Alpha Office Interiors set up the partitioning system within the facility.
Troax used modular steel for creating a 300m² cleanroom complex and divided it into a number of smaller partitioned test areas. The design of the partition incorporates double-glazed Toledo panels that enhance light and provide an airy working environment.
The Troax Toledo system is specially designed for cleanroom applications. It is made of a monobloc steel construction with the infill finish made using inert and non-particle shedding. The system is coated with powder paint for easy cleaning and prevention of particles collection. Toledo has flush line double glazing and a two-line panel junction that minimises the flush surfaces, ledges and corners.
The PDS Milton Park facility produces conventional dosage forms and formulates capsules, PIB, oral liquids, creams, ointments, suppositories and liquid-filled hard capsules. The specialised capabilities of the facility include early-phase development and the Quick to Clinic programme.
The Milton Park facility operations are fully supported by the Swindon PDS facility, situated approximately 56km away. The Swindon facility provides PDS for conventional, sterile, controlled-release and high-potency products.
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