Expansion Activity of CMOs - Pharmaceutical Technology

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Expansion Activity of CMOs
The outlook is fairly optimistic as contract manufacturing organizations (CMOs) gather at CPhI Worldwide in Frankfurt. CMOs are expanding capacity for small-molecules, biologics, and finished-product manufacturing.

Pharmaceutical Technology

Aptuit is also building its global footprint in India. In 2007, Aptuit and Laurus Labs Limited (Hyderabad, India) formed a new contract drug-development company, Aptuit Laurus (Hyderabad), as part of a phased acquisition. The deal positions Aptuit in the growing market for pharmaceutical outsourcing in India.

Aptuit Laurus will consist of a 160,000-ft2 research and development facility in Hyderabad, a large-scale manufacturing plant currently under construction in Pharma City, Vishakhapatnam, and Aptuit's existing informatics development and support group in Bangalore.

Aptuit says it plans to invest approximately $100 million during the next several years to build upon Aptuit Laurus's development, manufacturing, and informatics capabilities with the addition of a complete suite of development services, including medicinal chemistry, preclinical services, solid-state chemistry, consulting, clinical packaging and logistics, Phase I–IIa research, and large-scale dosage-form manufacturing. When these investments are completed, Aptuit Laurus will mirror the capabilities of services offered by Aptuit in North America and Europe. In addition, the new company plans to offer expanded services in discovery and clinical research and access to large-scale manufacturing at the backend of the product-development life cycle.

Patheon makes select investment and restructures

In secondary manufacturing, Patheon (Toronto) is expanding its Manati, Puerto Rico, facility to add a dedicated high-potency and controlled-substance manufacturing area. Patheon will invest a total of $2.8 million for a new 3386-ft2 area that will include three manufacturing suites, air-lock containment areas, and humidity-controlled air systems. The construction project is expected to be completed by October 2008.

Earlier this year, Patheon opened a new early-phase development facility in Milton Park in Oxfordshire, United Kingdom. The 13,500-ft2 , leased facility contains newly constructed formulation laboratories and a fully equipped analytical laboratory. The Milton Park operations will focus on the early-phase development of solid, semisolid, and oral liquid dosage forms. The facility includes GMP manufacturing areas for the production of materials for Phase I–II clinical trials. Patheon's "Quick To Clinic" programs, which accelerate molecules to clinical trials while minimizing API requirements, will be supported at the site.

These expansions follow recent restructuring. In April 2008, Patheon completed the sale of its York Mills facility located in Toronto for Can $12.5 million ($12.3 million). Patheon is transferring commercial production and development services undertaken at its York Mills facility primarily to its Whitby facility. A smaller portion of activity will be transferred to the company's Mississauga, Ontario, and Cincinnati, Ohio, facilities. Patheon is decommissioning the York Mills facility and has leased back the facility for as long as two years to facilitate this process.

In February 2008, Patheon completed the sale of its Niagara-Burlington commercial-manufacturing business to Pharmetics (Laval, Quebec, Canada), a privately owned contract manufacturer of vitamins, herbal products, supplements, and over-the-counter (OTC) pharmaceutical products. Pharmetics acquired the assets, including equipment, facilities, and land, at Patheon's facilities in Fort Erie and Burlington, Ontario. Collectively, the two sites currently serve 14 clients, manufacturing and packaging about 60 OTC pharmaceutical products in a range of dosage forms, including tablets, liquids, and powders.

Catalent strengthens biologics

Catalent Pharma Solutions (Somerset, NJ) will double its bioreactor capacity by adding a 1000-L bioreactor train in its Middleton, Wisconsin, facility by 2009. The expansion is in response to increased client demand for production to support clinical trials in Asia, Australia, Europe, and the US. Catalent supplies biotechnology companies with proteins made by its "GPEx" system, which produces stable, high-yielding mammalian cell lines for protein production.

Catalent also added a Phase I sterile vial-filling suite in its Research Triangle Park, North Carolina, facility, which complements the existing clinical and commercial manufacturing capabilities in its nearby North Raleigh facility. The new suite is designed to meet increasing market demand for early phase sterile-product development and manufacturing services. It will be equipped to fill vials with most highly-potent compounds, traditional small-molecule drugs and biologics, and controlled substances. Catalent has Phase I capabilities in blow–fill–seal and in prefilled syringes at its facilities in Woodstock, Illinois and Limoges, France, respectively.


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