Grifols announced that it has restated its 2005 agreement with OraSure Technologies. Additionally, Grifols is building a biological manufacturing facility in the San Francisco Bay Area.
Under terms of the agreement, Grifols supplies antigens for OraSure's OraQuick HCV Rapid Antibody Test. The test is FDA approved for qualitatively detecting hepatitis C virus antibodies in whole blood obtained through the use of a fingerstick or venipuncture. It enables healthcare providers to deliver results in 20 minutes from individuals 15 years of age and older.
"OraSure is committed to delivering high-quality infectious disease diagnostic products for our customers,” Douglas A. Michels, President and CEO of OraSure Technologies said. “As one of our trusted suppliers, Grifols' focus on service, quality and collaboration play a key role in our ongoing relationship.”
Additionally, Grifols is building a biological manufacturing facility in the San Francisco Bay Area. Grifols is in the process of validating the facility and preparing to file a license with the US Food and Drug Administration certifying proper design, monitoring, and control of manufacturing processes and facilities. The facility will provide commercial manufacturing for a developing product selection of diagnostic antigens, including proteins expressed in E. coli, yeast and mammalian cells.
The new Grifols manufacturing facility is expected to be completed in 2018.