Recombinant SARS-CoV-2 spike protein which is made by mammalian cell culture has been shown to be highly immunogenic and therefore, a potential candidate for a COVID-19 vaccine. However, purifying the spike protein at scales suitable for large-scale manufacture has proved to be very challenging. In this presentation, we are exploring a membrane chromatography-based purification technology for fast and scalable manufacture of a recombinant spike protein. This protein is much larger than most typical biopharmaceutical proteins. Therefore, its purification using resin-based chromatography is difficult. For one, the diffusive transport of this protein to and from its binding sites within the pores of the stationary phase particles is slow. Hence, very low flow rates need to be used during the binding and elution steps. This in turn, slows down the overall purification process. Also, on account of its large size, the binding capacity of this protein on typical resin-based chromatography columns is low. Membrane chromatography is an efficient and scalable technique for purification of biopharmaceuticals. The predominant mode of solute transport in membrane is convection. Therefore, it is considered suitable the purification of large proteins. In this presentation, we discuss the feasibility of purifying recombinant SARS-CoV-2 spike protein prepared by mammalian cell culture using cation exchange z<sup>2 </sup>laterally-fed membrane chromatography.

Purification of recombinant SARS-CoV-2 spike protein using membrane chromatography

ACS Spring 2022

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