Bioprocess Studies On The Production Of Staphylococcal Protein A Spa In Escherichia Coli

Abstract

Staphylococcal protein A (SPA) is a surface protein secreted by Staphylococcus aureus to newlineescape the host immune system by binding specifically to Fc region of immunoglobulins. newlineThis learning was exploited for its industrial use due to its specific and high-affinity newlineinteraction with immunoglobulins. Although known for almost 40 plus years for its newlineapplications in diagnostics and immunoglobulins purification, SPA finds its tremendous use newlinein the last decade as the ligand for affinity purification of monoclonal antibodies. This utility newlineof SPA as ligand is increasing exponentially with regulatory approval of a several newer newlinemAbs as drugs for new disease presentations. Biopharma industries also steadily moving newlinetoward the manufacturing of new and high volumes mAbs for therapeutics. Although newlineexpensive, most modern-day therapeutics are based on monoclonal antibody (mAbs) newlineplatforms, and most of its cost is contributed by capturing step of IgG during it purification newlineinvolving SPA-based resins. There are alternatives to SPA based resin as a capture step of newlineantibodies, however, SPA has been the preferred choice of mAb manufacturers since the newlineinception of its commercial use. Multifaceted consistent efforts are required to reduce the newlinecost of resin including the cost of SPA ligand. That will help the therapeutic segment to newlineevolve constantly to stay relevant, not only in terms of yields but also to keep the overall newlineprocesses cost-effective to make the products affordable. Along similar lines, SPA has to newlineevolve to accommodate all those stresses the processes offer and is poised to change even newlinefurther. For a process to be robust and cost-effective all the process intermediates also need newlineto be economical, stable and should be available with multiple vendors. To improve upon newlineprocess economics of SPA production, a three-pronged approach has been utilized in this newlinestudy. An effort has been made to establish a non-infringing process for the manufacturing newlineof SPA. The stages that were tapped upon to identify the ...