Use of Pall ForteBio systems significantly speeds downstream process development and optimization studies. Rapid quantitation of protein products and process-related impurities at multiple in-process points enables a detailed view of process performance and efficiency.
Label-free systems increasingly are being adopted for QC testing for drug substance and drug product, particularly for non-antibody drugs that cannot be analyzed using Protein A HPLC. Many studies have demonstrated excellent correlation between Octet platform determinations, A280 measurements, and HPLC analyses. View related articles.
Process Development and Validation
Pall ForteBio systems are powerful tools for optimization of protein capture, elution, purification, concentration, and polishing conditions. Titer determinations for in-process samples can be completed in a matter of minutes over a broad range of concentrations. View related articles.
Process-related impurities such as Host Cell Proteins and Residual Protein A must be stringently removed for product safety. These impurities usually are monitored at multiple in-process points, as well as for drug product specification testing. Impurity testing on the Octet® system generally provides lower detection limits than ELISA protocols, plus a 2-3 fold improvement in sample throughput. View related articles.