Patheon Manufacturing Facility Expansion, Toronto, Canada

Patheon, the Canadian contract drug maker, is expanding its Toronto manufacturing facility and is expected to complete the expansion by June 2009. The expansion will create an additional GMP space of 10,000ft² dedicated exclusively to the production of oral contraceptives. The output of the facility is expected to be 1.3 billion tablets per annum with the completion of the expansion.

The plant supports full-scale commercial production capabilities, including dispensing, granulation, compression, film coating and primary packaging. The expanded area is in compliance with the projected 2020 Ministry of Environment Standards and will adopt abatement technology for the elimination of solvent emissions.

The new site will be a Center of Excellence for Oral Contraceptives under Patheon's proprietary Quick to Clinic™ programme. The expansion of the Toronto site and having an exclusive space for manufacturing oral contraceptives is a regulatory requirement.

The expansion will increase the manufacturing capacity at the Toronto site for current as well as new business. Terry Novak, President of North America said, "This expansion positions Patheon to compete on a higher level for contract manufacturing opportunities and claim a larger portion of the global oral contraceptive manufacturing market."

The existing Toronto facility

The 263,000ft² Toronto facility of Patheon has a commercial manufacturing area of 228,50ft². It produces a full range of conventional solid, semi-solid and liquid dosage forms. It has specialised capabilities in high-potency and controlled-release products (including those manufactured using pelletisation, matrix, and coating approaches) and liquid-filled hard capsule (LFHC) formats.

The Toronto site is also characteristic of an integrated commercial manufacturing and packaging services. The Toronto operations region has a pharmaceutical development services (PDS) area spread over 34,500ft².

PDS Toronto deals with formulation development, process development, CTM manufacturing and scale-up services for various product candidate types. Comprehensive analytical testing, including customised ICH stability programmes, supports the development services. The integrated development services enable efficient scale-up of new products and the tech transfer of existing products within the facility.

Patheon's modern development facility has two formulation development laboratories and eight pilot-scale development suites – specially zoned and engineered for the development of high-potency compounds.

Manufacturing capabilities

Patheon's Toronto operations include a wide range of solid product manufacturing capabilities, including tablets (single and bi-layer), capsules, granules and powders. The facility can produce client-customised products (including potent drugs) with a vast array of modern processing equipment.

A multitude of flexible packaging options such as bottles, blisters and sachets are available for the solid products.

With extensive zoning infrastructure, strict material flows and employee training programmes, the Toronto facility efficiently handles many types of high-potency molecules with occupational exposure levels (OELs) in the low nanogram per cubic metre range.

The liquid and semi-solid product manufacturing includes solutions, suspensions, drops, creams and ointments. These can be packaged in various forms like tubes, jars and bottles.

Apart from this, the facility is efficient in the development and manufacture of nasal spray products.

Patheon

Headquartered in the US, Patheon provides drug development and manufacturing services to the international pharmaceutical and biotech industries.

With three facilities in the US, three in Canada and four in Europe, Patheon offers more than three million square feet (300,000m2) of best-in-class capacity.