Is Fiber-Based Protein A Chromatography the Missing Piece in Single-Use mAb Purification?

BPI Contributor

May 7, 2021

2 Min Read
Is Fiber-Based Protein A Chromatography the Missing Piece in Single-Use mAb Purification?

Protein A chromatography resins are widely used for therapeutic antibody production because they perform well, giving excellent recovery and purity. But resin-based chromatography methods are better suited to large-scale manufacture. In clinical monoclonal antibody (mAb) purification, batch sizes are small, so protein A resins are rarely used to their full lifetime potential. As a result, protein A resins may be cost-prohibitive, especially for mAb manufacturing when doses are very low or where target patient populations are small. Protein A resins also require column packing, cleaning validation, and storage of columns, which can be inefficient for work with small batches.

Cytiva’s Fibro PrismA is a fiber-based protein A chromatography technology that uses a cellulose fiber matrix for the capture step. This more open structure enables faster flow rates and shorter processing times — without the diffusional limitations of packed-bed chromatography resins or the capacity issues of membrane adsorbers. Researchers at Bayer and Cytiva evaluated Fibro PrismA for its potential in single-use mAb capture at multiple scales. The team compared pressure drop, step recovery, purity, and eluate volumes of Fibro PrismA units to that of protein A–based resins across multiple cycles.

Compared with protein A resin–based processes, Fibro chromatography showed potential for substantial gains in productivity. Yields were comparable to that of MabSelect SuRE™ protein A chromatography resins at all scales tested, and productivity was much higher. Yield purity was also comparable to that of protein A resins. Fibro required more buffer consumption and had higher eluate volumes, but there are ways to reduce both if a facility requires it.

Based on this data, the researchers concluded that Fibro PrismA could be beneficial in many clinical manufacturing applications.

Explore the data and learn more about the scalability, flexibility, and performance of Fibro PrismA units for rapid cycling protein A chromatography.

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