Biacore International AB (Biacore) has launched its new Biacore®3000 GxP Package, which will strengthen the system’s use in pre-clinical and clinical applications.
The new product is in 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 Biacore®3000 GxP Package provides a rapid, high quality kinetic analysis of biopharmaceuticals or small molecule therapeutics in the pre-clinical and clinical areas of drug development.
Biacore developed the system for use in regulated applications such as immunogenicity studies, biomolecular characterization and stability studies, ligand binding assays for potency and kinetics-based QC to expedite product release. The GxP package brings both legacy and new Biacore 3000 systems to comply with current USFDA 21 CFR Part 11 Regulations for electronic records.
With life science companies facing increasing pressure to bring new products to market faster while meeting ever stricter regulatory requirements, Julian Abery, Biacore’s Vice President and Head of the Pharmaceutical and Biotechnology Business Unit explained that the Biacore®3000 GxP Package had been "developed in response to our pharmaceutical and biotechnology customer’s requirements to complement our existing offering in this area."
With comprehensive validation support services, Biacore also supports its customers through the entire systems validation process, including equipment qualification and training carried out by GMP-trained personnel at the time the system is installed.
