Biosearch Technologies Launches New GMP Production Facility and Successfully Certifies to ISO 13485:2003
NOVATO, CA (THURSDAY, APRIL 18, 2013) – Biosearch Technologies, Inc. (Biosearch), a leader in the development and manufacture of GMP grade oligonucleotides, announced today the relocation of its GMP manufacturing process into a new, state-of-the-art GMP production facility in Novato, California. The 30,000 square foot facility was developed to further expand processes and controls relevant to medical device and molecular diagnostic customers.
“The GMP production facility is designed to incorporate the environmental and access controls, linear production flow and clean room processes critical for the controlled manufacture of highly-qualified diagnostic components, reagents and kits,” said Ron Cook, President and CEO of Biosearch Technologies. “Our new facility allows us to continue to support our diagnostic customers in a manner fully compliant with customer and regulatory requirements. This advanced facility also introduces pharmaceutical scale lyophilization capabilities allowing for state-of-the-art processing of molecular diagnostic assays in large scale single batches and all format types.”
In addition to the relocation to the new GMP production facility, Biosearch has successfully completed certification to ISO 13485:2003. This certification confirms that Biosearch has developed, implemented and maintains a Quality Management System able to meet the stringent requirements of medical device and molecular diagnostic manufacturing.
“Certification to ISO 13485 is a significant milestone for Biosearch and its GMP and Commercial Services production group,” said Jason Erickson, Director of Quality at Biosearch Technologies. “We have taken great strides to ensure a robust Quality Management System and successful certification to this standard demonstrates our commitment to quality at all levels within our organization.”
About Biosearch Technologies, Inc.
Biosearch Technologies, Inc. is a privately held, ISO 9001:2008/ISO 13485:2003 certified company, located in northern California. Founded in 1993, Biosearch is a leader in the design, development and manufacture of sophisticated oligonucleotide-based tools. Products include fluorophores (CAL Fluor®, Quasar® and Pulsar® dyes) and dark quenchers (Black Hole Quencher® dyes) to be included in custom-synthesized probe formats for real-time, quantitative PCR, Stellaris® RNA FISH, and other genomic-based applications.
In addition to basic R&D applications, Biosearch now leverages its demonstrated expertise in fully assembled RUO kits and in the cGMP-compliant manufacture of oligonucleotide components for molecular diagnostic assays. Biosearch Technologies is registered with the FDA (registration number 3003009052), and licensed by the State of California Department of Public Health Food and Drug Branch (license number 55563) as a medical device manufacturer. As such, its GMP and Commercial Services manufacturing processes conform to all applicable cGMP requirements per 21 CFR Part 820. Biosearch’s markets include pharmaceutical, in vitro diagnostics, biotechnology, ag/bio, environmental and food testing, public health, and biodefense sectors.