The new facilities ensure maximum safety for the sterile filling and lyophilization of Grifols coagulation factors. The fact that the license was awarded within 4 months reflects the company´s experience and reputation in regulatory affairs with the FDA.

Grifols has obtained approval from the Food and Drug Administration (FDA) for its new sterile filling area for coagulation factors, at its Los Angeles plasma products facility. The area is located in new purpose-built facilities designed to ensure maximum safety in the aseptic filling, sterilization and lyophilization stages of the Grifols coagulation factors: Factor VIII, Factor IX and Factor IX Complex. The area is expected to start operating during the second half of the year.
Validation by the US health authorities is the final stage of one of the first investments planned by the group for its Los Angeles plant where, since the purchase of the plant in 2003, the main goals have been to update and adapt the production processes to the standards in place at the Barcelona Spain production facility.

This approval was achieved in just 4 months, confirming the company's experience and know-how in regulatory affairs with official bodies, both in the United States (FDA) and in Europe (EMEA). It also represents recognition both of Grifols Sterile Filling (GSF) technology, patented by Grifols, and of Grifols Engineering, which was responsible for designing the entire project.

The building will also house a dedicated line for the sterile filling of albumin. The albumin filling suite is currently at the second stage of project execution, and the company expects to obtain FDA approval for them at the start of 2009.

Because the production of coagulation factors involves a biological starting material, aseptic filling and sterilization are one of the most critical stages. Grifols' constant technological innovation, through Grifols Engineering, to improve its productive processes, is aimed at ensuring maximum quality standards.