PITTSBORO, N.C., Sept. 27 /PRNewswire/ -- Biolex, Inc., a privately held protein therapeutics company, hosted today the Opening Ceremonies and Ribbon Cutting for its new clinical biomanufacturing facility. Honored guests attending the celebration included U.S. Representative Bob Etheridge, along with various local dignitaries and industry representatives. This new 4,500- square-foot biopharmaceutical manufacturing facility is located in previously undeveloped areas of the same building housing the company’s headquarters, research laboratories and existing preclinical manufacturing facilities in Pittsboro, NC.
The new clinical biomanufacturing facility will have capacity sufficient to produce one million doses per year of alpha interferon, a recombinant human protein used to treat infectious diseases such as Hepatitis C. Biolex is developing alpha interferon as its lead product. Biolex has initiated cGMP production of alpha interferon (production conforming to U.S. and international regulatory guidelines on current Good Manufacturing Practices) and expects to file an investigational new drug application (IND) with the U.S. FDA during 2004.
“This new facility provides Biolex important cGMP biomanufacturing capacity, and is a major step toward preparing our first product to enter the clinic in the coming months,” said Jan Turek, President and CEO of Biolex. “The new capacity is sufficient to support production of not only clinical and commercial-scale quantities of alpha interferon but also clinical-scale quantities of the other protein therapeutics we are presently expressing for our biopharmaceutical partners, while leaving significant room for further expansion. This will enable further growth under our strategy of producing proteins for partners while developing our own products.”
“This state-of-the-art facility is a boon to North Carolina’s economy and to the development of medicines to keep our families healthy,” said Representative Etheridge, Congressman for North Carolina’s Second District. “This kind of innovation and progress reinforces the leadership position of North Carolina in biotech and pharmaceutical industries. As North Carolina transitions from traditional industries to a technology-driven economy, the investments and innovation of companies like Biolex are critical to our economic growth and job creation.”
About Biolex: Biolex, Inc. is a private, venture capital-backed biopharmaceutical company. Biolex is developing recombinant human therapeutic proteins that, until now, have been impossible or very expensive to develop in existing expression systems. Biolex’ proprietary LEX System(TM) has demonstrated speed, regulatory and economic benefits with hard-to-make proteins and monoclonal antibodies. Biolex has a pipeline of proprietary products in development, and is partnering with pharmaceutical and biotechnology companies seeking the protein development and production benefits the LEX System(TM) offers. Biolex’ corporate partners include Bayer Corporation, Centocor, Inc., Debiopharm S.A., and a major pharmaceutical company. The Company’s headquarters, research laboratories and clinical manufacturing facilities are based in Pittsboro, North Carolina. Visit the Company’s web site at http://www.biolex.com/ .
Contact: John Irick, Senior Vice President and Chief Business Officer, Biolex, Inc., 919-542-9901; Michelle Linn, Linnden Communications, 508-869- 0138, michlinn@charter.net
Biolex, Inc.
CONTACT: John Irick, Senior Vice President and Chief Business Officer ofBiolex, Inc., +1-919-542-9901; or Michelle Linn of Linnden Communications,+1-508-869-0138, or michlinn@charter.net
Web site: http://www.biolex.com/