System for Kinetic Analysis of New Drugs
By Biotechdaily staff writers
Posted on 10 Apr 2003
A new system for use in preclinical and clinical applications is designed to facilitate compliance with worldwide regulatory requirements.Posted on 10 Apr 2003
The system, 3000 GxP, together with a predecessor C system, allows for rapid and high-quality kinetic analysis of well-characterized biopharmaceuticals and small molecule therapeutics. The 3000 GxP was developed for use in regulated applications such as immunogenicity studies, biomolecular characterization and stability studies, ligand binding assays for potency, and kinetics-based quality control to expedite product release.
The system was developed by Biacore International AB (Uppsala, Sweden; www.biacore.com).
"Drug companies are increasingly faced with the pressure of bringing new products to market faster while meeting ever stricter regulatory requirements. Biacore is committed to providing technology that addresses their needs through systems that not only deliver rapid, high-quality data, but that also meet the requirements for security and traceability of that data,” said Julian Abery, vice president and head of the pharmaceutical and biotechnology business unit of Biacore.
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