PITTSBORO, N.C., Oct. 18 /PRNewswire/ -- Biolex Therapeutics today announced that Glen Williams, Senior Vice President, Operations, presented its proprietary LEX System(SM) 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(TM), 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 applies its unique drug development capabilities and expertise to commercialize complex proteins and monoclonal antibodies that until now have been impossible or very expensive to develop through traditional means. Biolex' patented LEX System(SM) uses Lemna as a transgenic host in its GMP biopharmaceutical manufacturing facility to produce therapeutic proteins to support its own development programs as well as the programs of its strategic partners. The company is advancing a proprietary pipeline of product candidates, including its lead program Locteron(TM) for the treatment of hepatitis C under joint development with OctoPlus. Biolex has collaborations with Centocor, Medarex, and other 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' web site at www.biolex.com.
Michelle Linn, Linnden Communications, 774-696-3803, firstname.lastname@example.org