Grifols receives FDA approval for new albumin sterile filling plant in Los Angeles. This approval is the culmination of the project, which began three years ago, to completely overhaul the process of obtaining, purifying and filling albumin vials at Grifols Biologicals Inc. (Los Angeles).
The group’s engineering company, Grifols Engineering, has been responsible for designing and implementing this project in the United States. The project included developing the different systems for the collection, purification and sterile dosing of albumin in the new plant. Grifols Engineering’s experience in developing similar plants means that the new facilities have been designed to ensure very high productivity rates. Highly trained professional staff working with the very latest technology enabled the company to improve the efficiency and performance of the new facilities.
“The albumin production method at the Los Angeles plant was complex and inefficient,” explains Willie Zuñiga, president of Grifols Biologicals Inc. “With these changes, the Los Angeles plant will manufacture the same albumin as that produced in Barcelona.” The method used in Barcelona is much better from both a manufacturing and technical perspective. This approval, obtained in record time, is further evidence of the company’s skill and experience in handling regulatory procedures in both the United States (FDA) and Europe (EMEA).