Life Technologies to Invest $18 Million in Facility Expansion and Current GMP Compliance Plan
News Apr 02, 2013
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.
Streaming Protocol Makes Gene Data Sharing Future-ProofNews
The Large Scale Genomics Work Stream of the Global Alliance for Genomics and Health (GA4GH) has announced eight new implementations of its htsget protocol, a standard released in October 2017 for accessing large-scale genomic sequencing data online that does not depend on file transfers. The protocol and interoperability testing are reported in a paper released online this week in the journal Bioinformatics.
Antiviral Gene Vanquishes ZikaNews
It’s been known for years that humans and other mammals possess an antiviral gene called RSAD2 that prevents a remarkable range of viruses from multiplying. Now, researchers at Albert Einstein College of Medicine, part of Montefiore, have discovered the secret to the gene’s success: The enzyme it codes for generates a compound that stops viruses from replicating. The newly discovered compound, described in today’s online edition of Nature, offers a novel approach for attacking many disease-causing viruses.
Mechanism Controlling Multiple Sclerosis Risk IdentifiedNews
Researchers at Karolinska Institutet have now discovered a new mechanism of a major risk gene for multiple sclerosis (MS) that triggers disease through so-called epigenetic regulation. They also found a protective genetic variant that reduces the risk for MS through the same mechanism.