The platform, developed by Massacusetts-based Excelimmune, allows the expression of mixtures of recombinant antibodies and proteins within a single batch culture and has been exclusively licensed by contract development and manufacturing organisation (CDMO) Catalent in preparation for increased demand for combination biologic therapies.
“Polyclonal antibody cocktails better mimic the effectiveness and resistance to escape mutants exhibited by the adaptive humoral immune system of a healthy human being,” Mike Riley, VP of Catalent Biologics, told Biopharma-Reporter.com.
He added developers of biologic therapies are looking to combinations as a more effective treatment, particularly in areas like oncology and infectious disease, and the platform designed to make multiple different antibodies together as a single therapy will be broadly applicable to service this demand.
“The capability to make highly stable ratio of antibodies produced in single batch culture with large complex mixtures of antibodies while achieving cost competitiveness with a single monoclonal antibody therapy can enable new combination therapies that previously may not have been economically viable.”
The platform uses a stable pool of cells generated by multiple directed gene insertions which helps contribute to a quick, stable, and flexible culture system for mixtures of cells producing different antibodies.
Riley described the platform as “best in class in this space” and told us it could represent an important advance in antibody manufacturing technology.
“The Simplification of the process of generating an antibody combination therapy, reducing both time and effort involved; the reliable batch-to-batch consistency; the control over the relative expression levels of individual antibodies that make up the polyclonal mixture; and the very high stability of the cell banks over time with respect to production levels.”
Catalent will continue development work on the platform at its Madison, Wisconsin facility.