Octet® Systems in Ligand Binding Assays That Meet Compliance
Octet® systems enable analytical assessment of biologics in various stages of the development workflow beginning with discovery and early selection to validation, manufacturing and quality control. The instrument’s configuration and sample plate format coupled with real-time analysis allows for rapid assay method development. In the last couple of years, Octet® systems have been used by multiple organizations to generate supporting data submitted to various regulatory bodies for the approval of different biologics drug candidates. In addition, Bio-Layer Interferometry (BLI) technology, through the Octet® family of instruments has recently been cited in the United States Pharmacopeia General Chapters as an appropriate technique for ligand-based Fc-receptor binding studies.
Analytical instruments that offer simplicity and speed can greatly enhance operations under compliance requirements as they reduce the risk of errors while enhancing productivity. Sartorius offers Octet® GxP packages to support complete GMP compliant implementation. The packages include a GMP qualified Octet® instrument, 21 CFR Part 11 software with audit trails, software validation package, installation, and operational qualification (IQOQ) protocols and kits, user guides, performance qualification (PQ) protocols and kits, and biosensor validation support. The Octet® platform’s design and configuration coupled with its ease of use allows for enhanced productivity. The capacity to test for instance QC potency samples increases to 40X more samples over manual ELISA and up to 16X more samples per day compared to the majority of SPR platforms.