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GEN News Highlights : Mar 28, 2013
Life Tech’s Pleasanton, CA Facility Gets $18M MDx Makeover
Life Technologies said today it will carry out $18 million, multi-phase expansion of its facility in Pleasanton, CA, where it plans to add Current Good Manufacturing Practice (cGMP) capabilities for its genetic analysis products.
The first phase of the project consists of converting 10,000 square feet of existing space for manufacturing 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, with the goal of producing regulatory-compliant materials for qPCR workflows for clinical use.
Life Technologies said it will break ground during the second quarter on the expansion, which it said would help the company deliver on its commitment to broaden its offerings in the growing molecular diagnostics market.
"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, Life Technologies’ president and COO, said in a statement. "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."
The Pleasanton facility currently manufactures TaqMan® assays, GeneArt®, and Ion AmpliSeq™ product lines and other reagents that are part of Life Technologies' genetic analysis portfolio. According to Life Tech’s website, Pleasanton consists of a 95,000-square-foot manufacturing facility with capabilities for oligonucleotide manufacturing ranging from 0.2 uMole to milliMole scale; bulk oligonucleotide manufacturing volumes ranging from less than mL to liters scale; and specializations in highly purified primers, TaqMan probes, specialty oligos, TaqMan assays, plates, and MicroCards.
The plant employs an ISO9001:2008 certified quality system, with additional systems and site capabilities in place to achieve 13485/GMP regulatory compliance. Quality control and analytical services include high-performance liquid chromatography, UV/VIS spectrophotometry, fluorometry, mass spectrometry, and analytical capillary electrophoresis on the 310 and 3130xL platforms.
A Life Tech announcement of the expansion did not disclose how many employees now work at Pleasanton, and how many new jobs will be created through the expansion. Life Tech employed 210 people as of March 13, according to a list of "Pleasanton employers with 100 or more employees" posted on the city government’s website.
Pleasanton is one of 10 Life Technologies facilities worldwide. The company maintains manufacturing centers in Austin, TX; Bedford, MA; Carlsbad, CA; Eugene, OR; Foster City, CA; Frederick, MD; Singapore; and Oslo and Lillestrøm, Norway.
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