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Recent announcements of several new biopharmaceutical development and manufacturing sites point to the continued growth and internationalization of the industry, as European-based companies expand operations in the US and vice-versa.
Recent announcements of several new biopharmaceutical development and manufacturing sites point to the continued growth and internationalization of the industry, as European-based companies expand operations in the US and vice-versa. In recent weeks, the UK companies Angel Biotechnology Holdings, Plc, and Xceleron, and the US-based Ferro Pfanstiehl Laboratories and Lux Biosciences, have allannounced new facilities or strategic expansions, at home or abroad.
Expanding European Operations
Contract manufacturer Angel Biotechnology Holdings plc. (www.angelbio.com) has received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to carry out cGMP manufacture of investigational medicinal products at its new manufacturing facility in Cramington, Northumberland, UK. The license follows an MHRA inspection at the end of August of the company's quality systems and current good manufacturing practices that found them to be in compliance with the EU Clinical Trials Directive of 2001. Angel Biotechnology provides process development and cGMP manufacturing of biopharmaceuticals and pharmaceuticals, focusing on manufacture for early-stage drug development.
Lux Biosciences (Jersey City, NJ, www.luxbio.com), a privately held biotechnology company specializing in ophthalmic diseases, has announced the establishment of a subsidiary in Frankfurt, Germany. The new subsidiary, Lux Biosciences GmbH, will create the infrastructure for the company’s European activities. Lux entered into an agreement in September with New Jersey based Rutgers University (www.rutgers.edu) for access to the university's polyarylate patent for ophthalmic use. In May, the company obtained a worldwide license for a calcineurin inhibitor for ophthalmic treatments from Isotechnika, Inc.
Growth in the US
Xceleron Ltd. (York, UK, www.xceleron.com) announced on September 6 that it would open pharmaceutical testing facilities in the US in 2007. The company plans to invest as much as $7.5 million on building the new site, hiring personnel, and purchasing a new accelerator mass spectrometer (AMS) for drug candidate analysis. Xceleron opened its first US site in Gaithersburg, Maryland, in 2005. With its additional AMS equipment at the new site, which allows pharmacokinetic measurement of the absorption, distribution, metabolism, and excretion (ADME) of drugs administered in microdose quantities, the company hopes to take advantage of increased demand for such screening. This may result from the FDA's January 2006 guidance allowing microdosing studies, also referred to as “Phase O” trials.
Ferro Pfanstiehl Laboratories, Inc. of Waukegan, IL (www.ferro.com) has commissioned a new cGMP supercritical, fluid-based, particle-engineering pilot facility. The new facility will allow customers to use Ferro’s SCF technologies on a fee-for-service basis, aimed at allowing companies to explore the technology or to carry out work they cannot do with their in-house resources. The company's proprietary technology includes spray freeze-drying, which provides single-step lyophilization of proteins, biologicals, excipients, and some active pharmaceutical ingredients. The company also offers other particle-engineering technologies for use with biologicals and small-molecule drugs.