A high-efficiency, low-cost, single-use purification technology for therapeutic antibody manufacturing

Therapeutic antibodies have had a profound impact on treatment of many types of cancer and autoimmune diseasesAs a resultfive of the top ten best selling drugs ofwere therapeutic antibodiesMore than seventy therapeutic antibodies have been approvedand over six hundred antibody based products are in clinical developmentHoweverantibodies are extremely expensive to produceand large amounts of antibody are required to achieve clinical efficacyDuring our market research through the prestigious I Corps programall of the industry experts interviewed cited Protein A chromatography as the largest pain point in antibody manufacturingThe Z Domain of Protein A specifically binds the constant region of human antibodiesand thus can be immobilized on a resin or membrane and used to purify a wide variety of therapeutic antibodiesThe two largest concerns wereithe cost of Protein A modified chromatography resins or membranes andiithe time lost to lengthy cleaning proceduresThe goal of the proposed studies is to use new material and immobilization technology to produce a low costsingle use Z Domain immobilized membrane with high binding capacity and flow rateOur singlepot materials synthesis approach eliminates a work intensivefailure prone step from materials productionreducing the cost of membrane production and making single use application feasibleIn additionthis technology can increase binding capacity by nearlyfoldenabling its application for large scale purificationsFurthermorethese materials significantly stabilize incorporated proteinsfacilitating use and improving storageThe proposed studies of this proposal are designed to validate this approach in three value added milestonesMeasure static and dynamic binding capacityAimexamine antibody purityAimand assess the durability of the materialsAimall necessary steps in product development Therapeutic antibodies have had a profound impact on the treatment of many diseasesbut are extremely expensive to produceNovel materials developed by Bondwell TechnologiesInchave the potential to dramatically increase binding capacity in a low costsingle use productThe proposed studies will validate this technology as an antibody purification platform