Sweden's Biacore International, a specialist in surface plasmon resonance technologies, has launched its Biacore 3000 GxP (Good Manufacturing Practice/Good Laboratory Practice) Package, which will strengthen the system's use in preclinical and clinical applications. Biacore 3000 is the firm's system for label-free studies of biomolecular binding.
The new validation support service has been developed to facilitate compliance with worldwide regulatory expectations and will complement Biacore C, launched in 2001 for rapid concentration analysis in drug development, manufacturing quality control and in-process control applications.
Biacore 3000 enables rapid and high-quality kinetic analysis of both biopharmaceuticals and small-molecule therapeutics in the preclinical and clinical areas of drug development. The system was developed for use in regulated applications such as immunogenicity studies, biomolecular characterisation and stability studies, ligand binding assays for potency and kinetics-based quality control to expedite product release.
"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," commented Julian Abery, vice president and head of the company's pharmaceutical and biotechnology business unit.
In the meantime, Biacore noted that a new SPR array chip system, which will provide higher information content, is expected to reach the market in 2004.