The FDA approvals covered biologics license application (BLA) submissions for 26 monoclonal antibody based blood grouping reagents, two anti-human globulin products, 13 reagent red blood cell products and supplements to three previously licensed reagents.
Alquest also performed statistical analysis of the clinical data for the final clinical report to support the license applications. In addition to preparing the BLAs, Alquest functioned as Biotest’s US regulatory contact to support communications, interactions and responses with the FDA.
As a result, Biotest can now operate as a full service provider in the area of immunohaematology as one of only three companies to do so in the US.
Ann Quinlan-Smith, president of Alquest, said: “We are pleased to be able to support the commercialization of Biotest’s exciting automated systems and blood grouping reagents. Our team worked diligently with Biotest staff over a period of two years to earn these approvals. We are proud of their professionalism and effort.”