The Aug. 14 FDA approvals covered BLA submissions for 26 monoclonal antibody based Blood Grouping Reagents; 2 Anti-human Globulin products; 13 Reagent Red Blood Cell products; and supplements to 3 previously licensed reagents.
Alquest assisted the German manufacturer with project management and BLA submissions and supplements, and in developing CMC (Chemistry Manufacturing and Controls) systems and procedures, including:
- a quality assurance program to support licensed biologic IVD products;
- process validation protocols and report writing;
- stability test protocols, test methods and acceptance criteria;
- in-process product testing plans and acceptance criteria;
- establishing product specifications such as potency, specificity, microbial limits;
- establishing facility and utility controls and preparing validation packages.
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.
Alquest President Ann Quinlan-Smith 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.
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 U.S. The system developed by Biotest for automated blood group typing in blood banks and hospitals, TANGO(TM) optimo, including the associated test substances, was granted FDA approval in 2005.