MINNEAPOLIS--(BUSINESS WIRE)--Alquest, Inc. – the leading contract research organization (CRO) specialized in medical and diagnostic devices – recently helped its client, Biotest Medical Diagnostics GmbH, earn BLA (biologics license application) approvals through the Office of Blood Research and Review in the Center for Biologics Evaluation and Research of the U.S. Food and Drug Administration (FDA).
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.
“We are pleased to be able to support the commercialization of Biotest’s exciting automated systems and Blood Grouping Reagents,” said Alquest President Ann Quinlan-Smith. “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.
Alquest is a U.S.-based international CRO (contract research organization) specialized in medical devices, in vitro diagnostics and combination products. Alquest provides full-service regulatory, clinical and compliance services through its offices in Minneapolis, Minn., and Los Altos, Calif. Alquest employs senior professionals from the device and diagnostics industry to benefit clients by working smart from the start. Since 1993 Alquest has supported more than 375 medical device firms. Our clientele is national and international, including current medical device clients from Germany, UK, Switzerland, France, Australia, Japan and Korea. For more information, see www.alquest.com
Biotest AG, Dreieich, Germany, is a company that researches and manufactures pharmaceutical, biotherapeutic and diagnostic products and has specialised in immunology and haematology. In its Pharmaceutical segment, Biotest develops immunoglobulins, clotting factors and albumins based on human blood plasma. These are used for diseases of the immune system or haematopoietic system. In the Biotherapeutic segment, Biotest researches into the clinical development of monoclonal antibodies, including in the indications of rheumatoid arthritis and blood cancer. The Diagnostic segment spans reagents and immunological diagnostics which are used, for example, in blood transfusions and transplants. Biotest has around 1,800 employees worldwide and its shares are listed in the Frankfurt Stock Exchange's Prime Standard. For more information, see www.biotest.de
Dr. Michael Ramroth, +49 (0) 6103 801-338
Tom Huyck, +1-763-287-3830
Vice President, Business Development
Source: Alquest, Inc.