"As a provider of molecular companion diagnostic development and testing for the pharmaceutical and bio-tech industries, it is paramount that we have access to trustworthy oligos products that meet GMP compliance," said Byung-in Lee, senior director, research and development. "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, at 6055 Sunol Blvd., currently manufactures product lines that are part of Life Technologies' genetic analysis portfolio.
The first phase of the project will rework 10,000 square feet of floor 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 work flows 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 chief operating officer 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 900 compliant for the manufacture of a broad spectrum of products, including instruments, various reagents, assays, cell culture media and sera. It is a global biotechnology company that Stevenson said is committed to providing innovative products and services to 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, he added.
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