Charting Dosage-Form Manufacturing - Pharmaceutical Technology

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Charting Dosage-Form Manufacturing
Contract manufacturers expand capabilities in aseptic processing, clinical-trial materials supply, and cytotoxic manufacturing.

Pharmaceutical Technology

Pharmaceutical industry competitiveness at a crossroads
Catalent is also upgrading its clinical-supply facility in Bolton, United Kingdom, by expanding a temperature-controlled warehouse to meet demand for clinical supply services, especially cold-chain storage and distribution. The expansion involves a purpose-built extension of the existing facility and is expected to be operational in June 2008. The new temperature-controlled warehouse will have floor space of 7500 ft2 , 2700 controlled ambient storage locations, and will house a 320-pallet refrigerator. The expansion follows two already completed expansions at Catalent's other clinical-supply facilities in Europe (Schorndorf, Germany) and the United States (Philadelphia, Pennsylvania).

In addition to enhancing its clinical-trial materials capabilities, Catalent advanced its position in prefilled syringes. In November 2007, the company announced that it completed its first influenza vaccine manufacturing campaign for its new prefilled syringe manufacturing facility in Neder-Over-Heembeck, near Brussels, Belgium. The influenza vaccine production exceeded 21 million prefilled syringes for the 2007 campaign. The company's new prefilled syringe filling–finishing facility doubled its previous prefilled syringe capacity and replaces existing facilities in Brussels. Catalent received European regulatory approval for this facility in July 2006 and expects to have the first product approved by the US Food and Drug Administration at the facility in 2008.

Vetter Pharma-Fertigung (Ravensburg, Germany) started the construction of a new facility for visual inspection and secondary packaging. Vetter is a contract manufacturer of aseptic prefilled application systems. It is adding the new building close to Ravensburg Vetter South, its existing facility, at an investment of approximately EUR 20 million ($29 million). The new facility seeks to meet demand for homecare applications, including dual-chamber syringes and cartridges for pen- and autoinjectors and to meet new international requirements, such as the adoption of safety systems for anticounterfeiting, according to the company. The facility is scheduled to be operational by the end of 2008.

Keata Pharma (Toronto) opened a 46,400 ft2 -pharmaceutical manufacturing facility in Cape Breton, Nova Scotia, in November 2007. The facility includes offices for the pharmaceutical consulting division of PharmEng (Toronto), Keata Pharma's parent company, pilot laboratories for formulation development, rooms with various capabilities such as high-shear mixing, container blending, and equipment for modified-release technology. The facility provides formulation development and testing services for manufacturing and packaging products in solid and liquid dosage forms. Production is expected to begin in the first quarter of 2008. Keata's long-term goal is to develop capabilities in other dosage forms, such as suppositories, topicals, and injectables.

To that end, in late December 2007, Keata Pharma acquired Pfizer's (New York) 85,000-ft2 manufacturing facility in Arnprior, Ontario, including inventory. The acquisition gives Keata aseptic manufacturing capability. With the acquisition, Keata also entered into a supply agreement with Pfizer for the exclusive manufacture of certain Pfizer products for Canada at the Arnprior facility for a period of three years. Keata will also manufacture products from the Arnprior location for two other major pharmaceutical clients with multiyear supply contracts. The aggregate revenues of these multiyear supply contracts is estimated at C $75 million (US $72.5 million).

In late 2006, DPT Laboratories (San Antonio, TX) opened a new 258,000-ft2 research, development, manufacturing, and distribution facility. The $24-million expansion allowed the company to increase its formulation development and analytical chemistry capabilities. DPT is a contract manufacturer of semi-solid and liquid prescription, over-the-counter (OTC), and biotech drug products.


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