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Patricia Van Arnum was executive editor of Pharmaceutical Technology.
InformexUSA, San Francisco (Feb. 14?16)-Several contract manufacturing organizations (CMOs) and technology providers used InformexUSA to announce plans to expand manufacturing capabilities, increase service offerings, and ramp up other investments.
InformexUSA, San Francisco (Feb. 14–16)-Several contract manufacturing organizations (CMOs) and technology providers used InformexUSA to announce plans to expand manufacturing capabilities, increase service offerings, and ramp up other investments. Cambrex Corporation,Excelsyn, BioCatalytics, Inc., Cedarburg Pharmaceuticals, and Cambridge Major Laboratories were among the companies unveiling plans.
Cambrex Corporation (East Rutherford, NJ, www.cambrex.com) has initiated detailed engineering for an expansion at its Karlskoga, Sweden site to increase production capacity for small-molecule active pharmaceutical ingredients (APIs). This project, scheduled to start in July 2007 for completion by early 2009, will add a flexible, mid-sized CGMP manufacturing plant that will complement existing large-scale and small-scale facilities.
Cambrex Karlskoga currently produces over 20 commercial pharmaceutical products and completed over 30 clinical phase projects in 2006, using its kilo laboratory, multiple pilot plants and large-scale CGMP facilities.
Cambrex also plans to build new laboratory space to augment its existing high potency development facilities at its Charles City, Iowa site. This project will include the construction of an 11,500-ft,2 facility with five new process-development and kilo laboratory production suites for high potency APIs and enhanced facilities for analytical development and quality control activities.
Cambrex has other products and services which will be served by this expansion, including: development and manufacture of high potency polymer therapeutics and controlled substances; API taste-masking technology; and high potency API micronization.
Cambrex anticipates completion of this expansion, which will also accommodate up to 40 scientists and engineers, by early 2008. The Charles City site will receive financial assistance for this project from the Iowa Department of Economic Development as well as local economic development programs.
Excelsyn (Holywell, UK, www.excelsyn.com) is creating a Synthesis-at-Speed team to operate on a 24/7 basis on kilogram and pilot-plant API development projects. The company also is commissioning a three-phase, $10 million asset upgrade and expansion program for its Holywell, North Wales, facility, with the first phase to be completed during 2007.The second phase of the new investment at Holywell, focused on enhanced cleanroom facilities at 100-kg scale, is planned for completion during 2008.
BioCatalytics, Inc. (Pasadena, CA, www.biocatalytics.com), a provider of biocatalyst and enzymatic technology, formed a chiral technology agreement with Almac Sciences (Craigavon, Northern Ireland, www.almacgroup.com) under which the companies will cooperate on an exclusive basis for the development of processes and manufacture of chiral intermediates and APIs. BioCatalytics also launched a new enzyme product line for chemical synthesis in collaboration with Novozymes A/S (Bagsvaerd, Denmark, www.novozymes.com).
Cambridge Major Laboratories, Inc. (Germantown, WI, www.c-mlabs.com), a CMO of APIs, intermediates, and process development services, is partnering with Arlington Capital Partners (Washington, DC, www.arlingtoncap.com) to build a full-service drug-development organization focused on APIs, formulation and regulatory consulting. Cambridge Major will serve as the platform company and Arlington will provide capital to fund expansions and acquisitions in complementary businesses, including formulation, regulatory consulting, clinical packaging and distribution, and physical form determination. Cambridge will continue to be held by its current CEO Michael Major.
Cedarburg Pharmaceuticals, Inc. (Grafton, WI, www.cedarburglabs.com), a drug process development and API provider, raised a total of $3.5 million in the company’s Series A-3 (fourth round) of preferred-stock financing. Participants in the latest round include asset management company Sanders Morris Harris Group and Alfred Bader, founder of Aldrich Chemical (now Sigma Aldrich). Cedarburg recently received European approval to market cancer pain relievers fentanyl base and fentanyl citrate. The company holds drug master files for both fentanyl compounds in the United States as well as DEA Schedule I through V licenses and permits for controlled substances.