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.”