Confident GMP Compliance - Applications

Pall Fortebio‚Äôs comprehensive tool set for compliance makes the Octet RED96e system an ideal analytical instrument in regulated quality control (QC) labs for lot release and in-process testing for ligand binding, concentration and impurity analysis in both upstream and downstream processes. In addition, Octet systems have become a solution platform for potency analysis of drug-target and drug-Fc receptor(s) (FcγRI, FcγRIIa, FcRIII and FcRn) interactions. Moreover, Octet instruments are suitable for stability analysis that asses changes in activity in stressed and forced degradation assays. The high-throughput capability and flexibility of the platform enables rapid completion of assay method development through design of experiments (DOE) essential in identifying and controlling critical quality attributes (CQAs) that ensure consistent and reliable quality of biopharmaceutical products.

Octet quantitation assay for recombinant insulin.

Figure 1: Octet quantitation assay for recombinant insulin.

 

Affinity analysis of the binding of an IgG1 to an Fc gamma receptor as a function of deglycosylation.

Figure 2: Affinity analysis of the binding of an IgG1 to an Fc gamma receptor as a function of deglycosylation.