
NEWS 2006
[10/18/2006]
Biolex Therapeutics Featured At The 9th Annual Facilities For Mammalian Cell Product Conference
Conference Attendees Tour Biolex' Award-Winning GMP Biomanufacturing Facility
PITTSBORO, NORTH CAROLINA, October 18, 2006 - Biolex Therapeutics today announced that Glen Williams, Senior Vice President, Operations, presented its proprietary LEX Systemsm yesterday at the 9th Annual Facilities for Mammalian Cell Product Conference. Mr. Williams' presentation highlighted the benefits of the LEX System for the production of monoclonal antibodies and hard-to-make therapeutic proteins. Following his presentation, conference attendees toured Biolex' award-winning good manufacturing practices (GMP) facility in Pittsboro, North Carolina.
The presentation included an in-depth overview of the LEX System and a comparison of its benefits, including superior efficiency, robustness and scalability, compared to the mammalian expression systems that are primarily used today to produce monoclonal antibodies and other therapeutic proteins. Mr. Williams reviewed specific design features of the company's existing and future commercial GMP facilities. He also demonstrated how Biolex has been able to enhance monoclonal antibodies produced in the LEX System through glycosylation optimization.
"Biolex' approach to upstream operations provides a valuable alternative for the production of protein therapeutics," said Keith L. Carson, Chairman of The Williamsburg BioProcessing Foundation and host of the conference. "The conference participants who work with mammalian systems benefited from understanding a very different and interesting expression system that has achieved impressive results for monoclonal antibodies and other therapeutic proteins. Glen Williams' extensive experience with mammalian systems provided valuable insights for comparing the LEX System to more conventional cell culture production methods."
Conference attendees toured Biolex' GMP facility that is currently being used to produce clinical- and preclinical-stage proteins. During the tour, attendees were able to observe first hand how the company has transformed a host plant with CHO-like features into the LEX System, leading to faster product development and scale-up with lower capital and operational costs. Among the therapeutic proteins currently being produced at this facility is the Phase 2 GMP clinical supply of Locteron?, Biolex' lead product candidate for hepatitis C.
"Our consistent ability to provide clinical supplies for our own product-development programs coupled with the success achieved with our multiple corporate collaborations demonstrate the efficiency, robustness and scalability of the LEX System," said Glen Williams, Senior Vice President, Operations. "Other key advantages of the LEX System include the ability to produce proteins at commercially viable levels that were found to be hard-to-make in traditional expression systems, the lack of mammalian virus risk which reduces downstream steps and increases safety, and a favorable regulatory profile. Most recently, we have demonstrated for multiple partners with a variety of candidates the ability to produce monoclonal antibodies with optimized glycosylation in a homogeneous manner."
About Biolex Therapeutics
Biolex Therapeutics is developing and commercializing therapeutic proteins based on the LEX SystemSM, its patented expression system that enables the production of hard-to-make proteins and the optimization of monoclonal antibodies.
The Company is developing a proprietary pipeline of products that rely upon known mechanisms of action to provide a reduced risk profile while targeting large, proven pharmaceutical markets. Biolex's lead clinical candidate, Locteron? is being developed as a best-in-class controlled-release interferon alfa for the treatment of hepatitis C.
The Company's second product candidate, BLX-155, is a direct-acting thrombolytic, designed to break up clots in certain diseases such as acute peripheral arterial disease, deep vein thrombosis and catheter occlusion. In addition, the unique capabilities of the LEX System have led to collaborations with Centocor, Medarex and other leading pharmaceutical/biotech companies.
Biolex is a venture capital-backed company located in the Research Triangle region of North Carolina, United States. For additional information, please visit Biolex's web site at http://www.biolex.com
Contacts:
Media: Michelle Linn, Linnden Communications, 508-419-1555, linnmich@comcast.net
Investors: Dale Sander, Chief Financial Officer, 858-663-6993, dsander@biolex.com
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