Outsourcing Clinical Trial Development and Materials - Pharmaceutical Technology

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Outsourcing Clinical Trial Development and Materials
CROs and CMOs adapt their business models and capabilities to meet sponsor companies' need to reduce costs and accelerate development time.


Pharmaceutical Technology
Volume 6, Issue 34, pp. 44-46

Biopharmaceutical intensification

Intensification in biopharmaceutical development is another factor affecting the CTM sector, and contract-service providers are expanding in this area. Catalent (Somerset, NJ), a provider of advanced technologies and development, manufacturing, and packaging services, for example, opened a new temperature-controlled warehouse in Bolton, United Kingdom, to meet increased demand for clinical-supply services, including cold-chain storage and distribution, in October 2008.

Lyophilization Technology (Ivyland, PA), a contract provider of lyophilization services, recently invested in its CTM manufacturing capacity by expanding temperature-control capabilities for compounding and handling bulk solutions, incorporating vial-capping operations within an ISO 5 air-supply environment, and adding controlled-temperature storage for finished product, notes Edward Trappler, president of Lyophilization Technology. The company brought on a unit to process product from temperatures of 0–60 C in August 2009, developed an in-line chiller for bulk solutions immediately after compounding in January 2010, and expanded capacity for controlled storage at –20 C in October 2009.

Enhancing automation

Larger and more global clinical trials are another important consideration in CTM supply. "Automation in clinical-trial material supply is of increased importance as companies conduct larger trials, in part in response to FDA's interest to have data from larger studies," says Frank Lis, vice-president and general manager of clinical supply services at Catalent. "It is not uncommon to have 25–30 trial sites, distributed globally, with total patient enrollments of 5000 to 10,000 for late-stage clinical trials."

Lis offered several examples on how Catalent has improved manufacturing and packaging operations in CTM supply to meet demands of larger trials. In January 2010, Catalent announced the installation and qualification of a ZED in-line blister card sealer at its clinical-supply services facility in Philadelphia. The in-line blister-card sealer automatically places blister cards and blister strips, so the run time of carding jobs can be reduced. "To show the difference that automation can provide, we used to fill 500–1500 cards per eight-hour shift, and now can fill 5000–6000 cards per shift," says Lis.

Another example is the company's migration to a central server for designing, proofing, and validating labels for clinical packaging. The server environment allows these functions to be performed at a central location, rather than replicating them at each individual facility, and allows labels to be printed locally at each facility as required. "These types of improvements help to reduce timelines and costs in drug development, which are key in today's environment," says Lis.

Patricia Van Arnum is a senior editor at Pharmaceutical Technology, 485 Route One South, Bldg F, First Floor, Iselin, NJ 08830 tel. 732.346.3072,
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