Biosearch Technologies, a company that specializes in the development and manufacture of GMP-grade oligonucleotides, is moving its GMP manufacturing process into a new GMP production facility in Novato, CA, which is also the home of Biosearch's headquarters. 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. “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 facility, Biosearch says it has also successfully completed certification to ISO 13485:2003, meaning that Biosearch has developed, implemented, and maintains a quality management system able to meet the requirements of medical device and molecular diagnostic manufacturing. ISO 13485:2003, according to ISO's website, “specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.”
This news comes nearly two months after Biosearch acquired the oligonucleotide manufacturing division of DNA Technology and controlled-pore glass manufacturer VitraBio. Biosearch said the deal reflected its growing commitment to Europe’s biotechnology and diagnostic markets.