Outsourcing Clinical Trial Materials - Pharmaceutical Technology

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Outsourcing Clinical Trial Materials
CROs and CMOs expand to gain a piece of the market for clinical trial materials.


Pharmaceutical Technology
Volume 33, Issue 6, pp. 48-52

CROs and CMOs expand

During 2008 and 2009, several CROs and CMOs expanded or announced plans to enhance their CTM capabilities. Almac (Craigavon, Northern Ireland) is constructing a new approximately $100 million North American headquarters in Lower Salford, Pennsylvania, which is scheduled to be completed in 2010. When finished, a 166,600-ft2 facility will house clinical supply warehousing and storage, packaging, shipping and receiving, and label-control areas. A second 75,000-ft2 facility will house administration, communication, and a network-operations center. To accommodate growth until the new headquarters is completed, Almac added 6000 ft2 of space at its Yardley, Pennsylvania, facility. It also increased capacity for specialist storage of controlled and refrigerated clinical supplies with the opening of an additional storage facility in Craigavon, Northern Ireland.

In 2008, Azopharma (Hollywood, FL) expanded its manufacturing capabilities at its Hollywood and Miramar, Florida, sites with the addition of 17 new manufacturing suites to increase its capabilities to develop and manufacture CTMs. The addition of the 17 suites brings the company's total to 29. The company also added new laboratory facilities and office space in Welwyn Garden City, United Kingdom, which provides analytical, QP release testing, preformulation, and formulation-development services to the European market. Also, in 2008, Azopharma's clinical pharmacology research facility, AvivoClin Clinical Services, expanded its clinical research management services to include clinical study development, protocol design, clinical monitoring, and data management. The company also added microdosing and central laboratory services to complement its human clinical pharmacology services.

In December 2008, Patheon (Research Triangle Park, NC) opened its new US headquarters and analytical laboratory facilities in the vicinity of Research Triangle Park, North Carolina, and a new pharmaceutical development laboratory to support its pharmaceutical development operations in Cincinnati, Ohio. In October 2008, Patheon opened a new pharmaceutical development services suite for manufacturing products for Phase I–II clinical trials at its facility in Whitby, Ontario, Canada. The expansion supports Patheon's Quick to Clinic program, which was launched in 2008, and is designed for rapid CTM distribution for first-time-in human (Phase I) studies. Patheon also opened a 13,500-ft2 early-phase development facility for solid, semisolid, and oral liquid dosage forms in Milton Park, United Kingdom.

Patheon is using partnerships to advance its CTM capabilities. In November 2008, it signed a master-service agreement with the CRO Omnicare Clinical Research (King of Prussia, PA) for CTM distribution in Europe and the Asia–Pacific region. Omnicare is providing Patheon's customers with various clinical supply services that include monitoring, distribution, and return accountability. Also, in support of its Quick to Clinic program, Patheon formed a global alliance in 2008 with Solvias (Basel, Switzerland) for early-development services, including characterization of active pharmaceutical ingredients, salt selection and cocrystallization, polymorphism screening, solubility determination, excipient compatibility, and formulation.

In 2008, Bilcare Global Clinical Supplies (Phoenixville, PA) expanded its packaging operations and storage capacities at its facility Pune, Maharashtra, India, to allow for the manufacture, packaging, and distribution of CTMs through its in-house interactive voice response system. Other recent CTM investments include an expansion of its US operational capabilities with additional packaging rooms, new high-speed blistering technology, a large-scale bottling line, and a tripling of its ambient storage capacity. The company's US facility expanded preclinical and early-stage development capabilities to include upgraded granulation and capsule-filling technology and enhanced capacity for formulation and analytical-development services. Similar packaging technology upgrades took place at its UK facility. Bilcare strengthened its CTM distribution in Argentina, Brazil, Columbia, Chile, Mexico, Peru, Russia, and Eastern Europe by forming an agreement with World Courier, a specialty courier company with cold-chain expertise.

Piramal Healthcare (Mumbai) has made several investments to support its clinical-trial service capabilities. In August 2008, Piramal launched clinical trials supply capabilities from its Morpeth, United Kingdom, manufacturing site. The newly equipped facility offers primary packaging of solid-dosage forms, including multidose blistering and walleting. A reconfigurable suite of secondary packaging booths are set up for the labeling and assembly of various dosage forms, and distribution is also available. Expansion is in the future footprint through plans to double primary and secondary packaging capacities. The company also opened a 50,000-ft2 solid-dose formulation-development and GMP (good manufacturing practices) CTM center in Ahmedabad, India, in December 2008. Scientists will work in two shift operations at the development center, which enables reduced project execution timelines and allows availability to customers in different time zones.

Catalent Pharma Solutions (Somerset, NJ) added a 1000-L bioreactor train in its Middleton, Wisconsin, facility to meet increased CTM demand. In October 2008, Catalent opened a 11,800-ft2 temperature-controlled warehouse in Bolton, England, to meet demand for clinical supply services, especially cold-chain storage and distribution.

Last October, Aptuit (Greenwich, CT) launched a program to accelerate early-stage drug development. Aptuit INDiGO is a customizable program that offers an accelerated track from preclinical candidate selection to regulatory submission to support Phase I clinical trials. In January 2009, Irvine Pharmaceutical Services (Irvine, CA) launched Avrio Biopharmaceuticals to provide formulation development and aseptic fill–finish services for early-phase CTMs. And Analytical Bio-Chemistry Laboratories expanded into a new 90,000-ft2 pharmaceutical development facility in Columbia, Missouri, which includes GMP development and analytical laboratories with 43,000 ft3 of stability storage. The company offers GMP radiolabelled materials for human studies and has expertise in impurity profiling and identification.


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