Enables rapid and high quality kinetic analysis of both well characterised biopharmaceuticals and small molecule therapeutics in the pre-clinical and clinical areas of drug development
Biacore has announced the launch of its Biacore3000 GxP package, which will strengthen the system's use in pre-clinical and clinical applications.
The new product was 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.
The combined Biacore3000 GxP package enables rapid and high quality kinetic analysis of both well characterised biopharmaceuticals and small molecule therapeutics in the pre-clinical 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 QC to expedite product release.
The addition of the GxP package enables both legacy and new Biacore 3000 systems to meet current USFDA 21 CFR Part 11 regulations for electronic records.
"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 pharmaceutical and biotechnology business unit. "Our Biacore3000 GxP Package was developed in response to our pharmaceutical and biotechnology customers' requirements to complement our existing offering in this area."
