With an increasing number of antibody therapeutics and higher cell culture titers from intensified upstream processes, manufacturing batch sizes are smaller and more diverse. Consequently, single-use multi-product manufacturing facilities are utilized as they provide the flexibility necessary to meet these changing demands. These driving forces motivated us to evaluate ProteinA-derivatized Fibro, a single-use chromatography technology, in meeting the goals of our future manufacturing platform.<br/>Implementing a fully single-use manufacturing platform can be challenging as bead-based ProteinA resin chromatography has anchored industrial production of antibodies. ProteinA resins have an excellent record of clearing impurities while consistently delivering high quality products. Typically, large columns are used during clinical manufacturing to reduce processing times and are thus rarely exhausted of their entire lifetime capacity. This results in under-utilization, high initial costs and storage concerns. Fibro ProteinA enables rapid purification of monoclonal antibodies by offering faster mass transfer, high capacity, and fuller utilization within a single production batch. It offers the potential of delivering the same product quality as that of ProteinA resin with a potential cost- and time saving during clinical productions.<br/>Bench-scale Fibro studies performed across a range of monoclonal antibodies indicate its feasibility as a platform approach. To assess its scalability, pilot-scale case studies were conducted. They demonstrated its single-use facility fit, productivity benefits, and product-quality comparability to those of resin-based processes. Additionally, these pilot-scale studies addressed concerns over their adoption due to the disadvantages of membrane-like technologies, namely higher buffer consumption, larger elution pool volumes, and shorter device lifetimes. As Fibro units were scaled up, the buffer consumption, elution volume and lifetimes were found to be comparable to those of resin-based affinity chromatography.<br/>We evaluated the feasibility of implementing FibroA chromatography into a future mAb manufacturing platform. While there remain uncertainties surrounding long-term process economics at a manufacturing scale, this technology allows for productivity increases, cost-savings, and flexibility. We envision its potential for a paradigm shift in manufacturing antibodies in the future.<br/>

Protein A fibro chromatography as a platform affinity capture of the next-generation manufacturing process of antibody therapeutics

ACS Fall 2020 Virtual Meeting

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