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

Patricia Van Arnum
The outlook for contract dosage manufacturing bodes well. Increased outsourcing by the pharmaceutical majors, strong market projections, and recent expansion activity by several contract manufacturers are favorable indicators for select segments of the market.

Market growth

The market for contract manufacturing of bulk and dosage form prescription drugs was estimated at $30.7 billion in 2006 and is expected to reach $46.5 billion by 2011, according to a recent analysis by Business Communications Company (BCC). This increase represents compounded annual growth of 8.7% between 2006–2011 and a near doubling of the market by 2011 from 2004 levels, when it was estimated at $24.6 billion.

Expansion activity

In keeping pace with that growth, several leading contract manufacturers announced expansions last year in select segments. In November 2007, DSM Pharmaceuticals (Parsippany, NJ) expanded its service offerings to include formulation development and clinical- trial manufacturing for solid-dosage form products. DSM has a well-established presence in commercial manufacturing of solid-dosage products at its Greenville, North Carolina, facilities, and the move allows the company to offer formulation development and clinical-trial materials supply at Greenville.

In January 2007, DSM completed an expansion to its sterile parenteral manufacturing facility in Greenville by adding a clinical-trial material manufacturing suite. The suite can manufacture large- and small-molecule liquid and lyophilized products for Phase I–III clinical trials.

In addition to expanding its formulation development and clinical-trial materials supply, DSM added aseptic fill–finish manufacturing service for injectable cytotoxic products. The aseptic cytotoxic capabilities include flexible commercial-scale fill-finish services for liquid and lyophilized products in vial sizes up to 65 mL. The facility was scheduled to be ready for commercial production in January 2008, according to a September 2007 company release.

Other companies expanded cytotoxic contract manufacturing capabilities in 2007. Baxter BioPharma Solutions (Round Lake, IL) expanded its lyophilization capacity at its cytotoxic contract manufacturing facility in Halle, Germany. The expansion, which was announced in September 2007, increased the company's total cytotoxic lyophilization capacity to more than 1100 ft2 and four dedicated lyophilizers. Two large-scale lyophilization units were added as well as an automated loading cart and in-process quality analysis technology.

Catalent Pharma Solutions (Somerset, NJ) reported several expansions in 2007. In November, the company reported that it was adding a Phase I sterile vial-filling suite in its Research Triangle Park, North Carolina, facility. The expansion complements existing clinical and commercial capabilities at the company's North Raleigh, North Carolina, facility. The suite will be equipped to fill vials with most highly potent compounds, traditional small molecules, biologics, and Drug Enforcement Administration Schedule 1–5 compounds. The suite is scheduled to be completed in early 2008 and will offer liquid-fill and lyophilization capabilities. Catalent has Phase I capabilities in blow–fill–seal and in prefilled syringes in its facilities in Woodstock, Illinois, and Limoges, France, respectively.


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