Outsourcing Clinical-Trial Materials Heats Up - Pharmaceutical Technology

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Outsourcing Clinical-Trial Materials Heats Up
The outsourcing of clinical-trial materials grows as pharmaceutical companies adapt to a changing market.

Pharmaceutical Technology
Volume 32, Issue 1

But restructuring is not the only reason that large and mid-sized companies outsource CTM. Anthony Moult, director of global clinical-trials supplies at UCB Pharm (Braine-l'Alleud, Belgium), notes that the primary reason his company outsources a given project is usually that it cannot be done in-house. "For example," Moult explains, "we don't really have a clinical-trials supplies capability for the storage and distribution of large volumes of refrigerated products." UCB generally looks to vendors to supply these services.

"Our internal approach," he adds, "is if we haven't got the technology, we contract it out. If we have internal capacity and, looking three, six, or twelve months out, we would be overloaded by our current plans, then we would look to strategically and tactically outsource the packaging and distribution of those materials."

Outsourcing aids small companies

Small pharmaceutical companies must outsource CTM services when they lack capacity and expertise. They "may have limited experience with drug-development activities, especially CTM," Spataro observes. "They have limited internal operations," she says, "and therefore must rely on contract providers for an array of product-development services such as formulation development and clinical-trial material manufacturing, packaging, and distribution."

CMOs agree that small and emerging companies are an important part of the outsourcing equation for CTM supplies. Meeks says most of Azopharma's CTM projects now come from small and mid-sized companies. Virtual companies must outsource many projects because they don't have the internal operations to complete them, he observes.

Aptuit continues to receive a steady number of contracts from small and emerging pharmaceutical companies, which are an important customer base for the company, according to Houlton.

Still, Houlton stresses that Aptuit "works with customers of all sizes—from virtual to large pharmaceutical companies—to help them advance their compounds from discovery to launch."

Outsourcing CTM is not a strategy that is limited to one segment of the pharmaceutical industry. Bhatt says, "All the players are outsourcing CTM. More and more, companies must fail faster and in a cheaper manner, so the [outsourcing] activity is by everybody."

Contract organizations expand

Responding to increased demand, CMOs are expanding their CTM-supply capabilities. In January 2007, DSM Pharmaceuticals (Parsippany, NJ) added a CTM manufacturing suite to its sterile parenteral manufacturing facility in Greenville, North Carolina. The suite manufactures large- and small-molecule liquid and lyophilized products for Phase I–III clinical trials. In November 2007, DSM added formulation development and clinical-trial manufacturing for solid dosage forms to its service offerings.

In April 2007, AAIPharma (Wilmington, NC) completed $2 million worth of upgrades to its parenteral manufacturing facility in Charleston, South Carolina, and its sterile-product release operation in Wilmington. The improvements were designed to increase capacity and ensure compliance with European Union aseptic-processing and testing guidelines. Lee Karras, senior vice-president of North American pharmaceutical operations, said that the upgrades were "of particular importance to customers who wish to conduct clinical trials in the EU." The EU's Clinical Trials Directive harmonizes the conduct of clinical trials and affects the manufacture and importation of CTM into the region.

Bilcare Global Clinical Supplies (Pune, India) opened five primary packaging rooms at its Phoenixville, Pennsylvania, facility in November 2007. The company planned to achieve the next phase of upgrades during the fourth quarter of 2007 by creating five additional primary rooms. The expansion would give Bilcare 10 primary and 16 secondary packaging rooms within its 153,000-ft2 US operation.

In addition, Bilcare is investing 11 million ($23 million) to establish a new clinical-supplies facility in Wales. This facility will replace the existing clinical-supplies facility Bilcare acquired in 2006.

In November 2007, Catalent Pharma Solutions (Somerset, NJ) added a Phase I sterile vial-filling suite to its facility in Research Triangle Park, North Carolina. The suite complements the clinical-manufacturing capabilities at Catalent's North Raleigh, North Carolina facility.


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