Life Technologies to Invest $18 Million in Facility Expansion and Current Good Manufacturing Practice Compliance Plan
Published: Mar 28, 2013
"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.
About Life Technologies
Life Technologies Corporation (NASDAQ: LIFE) is a global biotechnology company that is committed to providing the most innovative products and services to leading customers in the fields of scientific research, genetic analysis and applied sciences. With a presence in more than 180 countries, the company's portfolio of 50,000 end-to-end solutions are secured by more than 5,000 patents and licenses that span the entire biological spectrum -- scientific exploration, molecular diagnostics, 21st century forensics, regenerative medicine and agricultural research. Life Technologies has approximately 10,000 employees and had sales of $3.8 billion in 2012.
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