Optimization of scalable chromatography-based purification methods utilizing NatriFlo HD-Q membrane technology for downstream processing of viral vaccines and viral vectors

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Viruses engineered to express antigens to promote a protective immune response against a particular pathogen(vaccine), or to deliver a therapeutic gene (gene therapy) or to treat cancer (oncolytic virotherapy) are essentialtools used in the prevention and treatment of diseases in humans and animals. However, a considerableimpediment to the use of viruses as vaccines or therapeutic agents is the availability of efficient, scalablepurification systems. The goal of this project is to build upon the process development expertise acquiredduring our initial NSERC Engage funded collaboration with Natrix Separations, in which we successfullydeveloped a process for purifying high titer, clinical grade Newcastle Disease virus, and apply this knowledgeto the design, optimization and dissemination of detailed process purification protocols for production of hightiter, clinical grade viral vaccines and gene transfer vectors using NatriFlo HD-Q membrane technology. NatrixSeparations is a leading supplier of high performance, single use and multi-cycle chromatography products tothe life science markets. Their membrane chromatography columns are used in a variety of applicationsincluding the separation and purification of peptides, proteins, nucleic acids, and monoclonal antibodies. Togrow their business, Natrix is seeking to broaden their patented separation technology platform to includepurification of clinical grade viral vaccines/vectors and oncolytic viruses for use in humans and animals. WhileNatrix has the chromatographic devices and process development expertise, they do not have the infrastructure(CL2 lab and animal facilities, access to viruses) or the virology expertise necessary to conduct theseexperiments. Therefore, it is absolutely critical that Natrix partner with an academic virology lab to developvirus-specific purification processes and evaluate the activity and purity of the final product in an animalmodel. Indeed, that was the premise of our initial NSERC Engage grant. Due to the tremendous success of thiscollaboration, we are now applying for funding to develop and test anion exchange and affinitychromatography-based purification processes for a variety of clinically relevant viral vaccines and viral vectors.