New Manufacturing Facilities Announced - - BioPharm International

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New Manufacturing Facilities Announced

BioPharm Bulletin

Eden Biodesign (Liverpool, UK, www.edenbiodesign.com), SAFC (St. Louis, MO, www.sigmaaldrich.com/SAFC/Pharma), Midatech Group (Oxfordshire, OX, www.midatechgroup.com), Cellexus Systems (Cambridgeshire, UK, www.cellexusbiosystems.com), and BioConvergence LLC (Bloomington, IN, www.bioc.us) are sprucing up their product development and services with the construction of new manufacturing facilities.

Eden Biodesign has announced full operation of its state-of-the-art good manufacturing practices (cGMP) manufacturing facility in Liverpool, UK. The company has been awarded a license by the UK Medicines and Healthcare Products Regulatory Agency (MHRA, London, UK, www.mhra.gov.uk) to manufacture investigational medicinal products (IMPs) at its new facility, the UK National Biomanufacturing Centre (Liverpool, UK, www.biomanufacturing.co.uk). The new license will provide legal authority for Eden to manufacture biopharmaceutical drug substances under contract for clients for use in EU clinical trial sites. Eden recently announced agreements to provide development and manufacturing services to ImmBio (Cambridge, UK, www.immbio,com) and Onyvax (London, UK, www.onyvax.com).

Midatech Group has announced the opening of its specialist design and manufacturing facility for cGMP grade nanoparticles in Bilbao, Spain. Midatech Biogune S.L. is the world’s first cGMP grade manufacturing plant for the production of nanoparticles at a scale commensurate with pharmaceutical applications. The plant’s staff will initially focus on the design and manufacture of nanoparticles to supply the Midatech Group’s projects applying nanotechnology for therapeutic purposes. These include using nanoparticles as scaffolds for synthetic vaccines and antibiotics, as drug delivery vehicles for RNAi drugs and drugs able to cross the blood brain barrier, and targeted cancer treatments and imaging agents.

SAFC, a member of the Sigma-Aldrich group, has announced the construction completion of two major new protein API facilities at its St. Louis, MO, manufacturing campus. A new biologics manufacturing facility consists of a 25,000 sq. ft. cGMP purification and manufacturing suite for transgenic plant and other nonanimal derived protein APIs and a 6,000 sq. ft. facility for purification of animal-derived protein APIs. Validation for commercial operation of this $16-million expansion at the 400,000 sq. ft. St Louis manufacturing campus is expected by mid-year 2007.

Cellexus Biosystems has relocated its headquarters to new offices and research laboratories in Huntingdon, Cambridgeshire. The facilities have been designed to house both the company’s central operations, sales and marketing, and purpose-built research laboratories for the culture of bacterial, insect, and mammalian cells—the three main types of cells that the company’s customers grow in the its CellMaker bioreactor products.

BioConvergence LLC is expanding its Bloomington headquarters to serve its clients in the biotech and pharmaceutical services sectors. The company will add approximately 20,000 sq. ft. to its existing facility to accommodate growing demand from its clients, particularly in its cGMP materials management business unit. The expansion also adds approximately 15 new employees to its existing employee base of 21 full-time employees and includes a multimillion-dollar investment in facilities and equipment.

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