Life Technologies Corporation announces plans to invest $18 million in a multi-phase plan to expand its facility in Pleasanton, Calif., where it will implement Current Good Manufacturing Practice (cGMP) capabilities for its genetic analysis products. The project, which executes against Life's roadmap to broaden its offerings in the growing molecular diagnostics market, will break ground in the second quarter of 2013. The expanded facility will provide accessibility for customers on a global scale and enable more efficient business continuity planning.
"As a provider of molecular companion diagnostic development and testing for the pharmaceutical and biotech industries, it is paramount that we have access to trustworthy oligos products that meet GMP compliance," said Byung-in Lee, Ph.D., MBA, Senior Director, Research & Development for AltheaDx. "Reagents such as those planned in Life Technologies' new manufacturing facility are essential for meeting regulatory requirements and will help speed up our companion diagnostic development and validation process."
The Pleasanton facility currently manufactures TaqMan® assays, GeneArt® and Ion AmpliSeq™ product lines and other widely used reagents that are part of Life Technologies' genetic analysis portfolio. The first phase of the project will repurpose 10,000 square feet of space to manufacture molecular probes and primers under cGMP standards. Subsequent phased expansions totaling an additional 30,000 square feet will follow over the next one-to-three years to produce regulatory-compliant materials for qPCR workflows in the clinical space.
"We are committed to providing the highest quality products that help meet the specific needs of our growing diagnostic and pharmaceutical customer base," said Mark Stevenson, President and COO of Life Technologies. "The expansion of our Pleasanton facility and plan to achieve cGMP certification underscores our growth strategy in new markets and our commitment to win in genetic analysis from discovery to diagnostics."
Products manufactured in cGMP-certified facilities ensure their quality meets standards of control for use in the pharmaceutical and medical fields. Life Technologies currently has nine facilities that follow cGMP standards and are ISO 9001/13485-compliant for the manufacture of a broad spectrum of products, including instruments, various reagents, assays, cell culture media and sera.