03.22.06
PITTSBORO, NORTH CAROLINA – Biolex Therapeutics was awarded special merit recognition in a global competition for excellence in pharmaceutical manufacturing facilities. Biolex was presented the award in New York at the INTERPHEX 2006 Conference and Exhibition, the world’s largest and most comprehensive pharmaceutical manufacturing conference. Biolex was recognized for the 2005 expansion of its Good Manufacturing Practice (GMP)-certified production facility in Pittsboro, N.C.
“Developing and producing therapeutic proteins economically and efficiently requires innovative, state-of-the-art facilities. We believe we have created such a facility, and we’re very pleased that the judges for this prestigious award have recognized our accomplishments,” said Jan Turek, President & Chief Executive Officer of Biolex. “The success of this expansion demonstrates the ability of the LEX SystemSM to complete validation and start-up quickly, with lower capital and operational costs requirements.”
The Facility of the Year Award is a global award focused on innovation and creativity in manufacturing facilities serving the regulated health care industry. The awards are sponsored by the International Society of Pharmaceutical Engineering (ISPE), INTERPHEX and Pharmaceutical Processing magazine. The international judging panel consists of eight industry experts with significant experience in pharmaceutical design, engineering, construction management, and manufacturing.
Biolex received a special merit recognition award for the expansion of its production facility, which is Good Manufacturing Practice (GMP)-certified. This project was completed in 5 months from design through validation, compared to the 2-3 years required for traditional systems. The reduction in time allows capital to be invested later in the clinical development pipeline, potentially avoiding capital investment risk. The expansion doubled Biolex’s capacity for the production of therapeutic proteins, and the company now has 90 employees at this GMP facility. Among the therapeutic proteins currently being produced at the expanded facility are the Phase 2 GMP clinical supplies of LocteronÔ, Biolex’ lead product for hepatitis C. The expansion also allows Biolex to meet the growing requirements associated with its current and future corporate partners.
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 SystemSM 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 LocteronÔ under joint development with OctoPlus. Biolex has a multi-protein strategic alliance with Centocor and collaborations with other pharmaceutical/biotech companies including Medarex. 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.
About Facility of the Year
Sponsored by ISPE, INTERPHEX and Pharmaceutical Processing magazine, the Facility of the Year Award is the first global competition of its kind to recognize the talent and creativity required to manufacture pharmaceuticals safely and efficiently. The Facility of the Year Award is an annual event focused on newly constructed state-of-the-art pharmaceutical projects. By recognizing those manufacturers who are using new technologies both to improve the quality of their products and to reduce the cost of producing medicines, the award seeks to promote technological innovation across the industry.
The ISPE is the leading not-for-profit society of pharmaceutical manufacturing professionals worldwide. INTERPHEX is an annual conference and exhibition for the pharmaceutical manufacturing industry. Pharmaceutical Processing is a monthly magazine for pharmaceutical and biopharmaceutical professionals.
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