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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