Quality of recombinant/therapeutic proteins produced by engineered cell lines is a concern shared by both manufacturers and regulatory agencies. New assays are needed to facilitate earlier and more rapid analysis of therapeutic protein quality. Cell culture supernatant contains secreted proteins that are indicative of the cellular condition and thus are potential indicators of recombinant protein quality. This study identified changes in secreted host cell proteins (HCP) from cell pools exhibiting varying levels of recombinant antibody expression as determined by quantitative…
Monday, November 8, 2010 Daily Archives
Fc-Specific Mix-Mode Ligand for Monoclonal Antibody Purification
APT1604 is a base-stable 600 Da peptidometic ligand coupled to a 6% cross-linked agarose matrix. APT1604 binds to Fc-fragment of monoclonal antibodies (mAb) and various immunoglobulin (IgG) subclasses. The interaction between protein and ligand has been suggested to result from mixed mode ionic – hydrophobic interactions, albeit with high selectivity for immunoglobulins. The main application area for APT1604 is purification of mAb from mammalian cell harvest, but it can also be used for purification of IgG from other sources. The…