#3 Boosting mAB Manufacture
mAbs are an important growth area forthe biopharma industry – so we need more effective purification technologies.
David Westman |
Protein A resins are already advanced – why is it important to continue to innovate?
Monoclonal antibodies (mAbs) continue to be the largest and fastest growing class of biotherapeutics, so ensuring continued efficient process development and good manufacturability is important. Protein A resin, with its high specificity and affinity for the Fc region of antibodies, enable a plug-and-play approach where up to 99 percent purity can be achieved in one, almost generic, purification step. It’s relatively easy and cost effective to set up a purification platform that can accelerate process development and enable fast turnover of mAb projects.
The bioindustry has seen a more than a 100-fold increase in the productivity of cells in the upstream part of the biomanufacturing process, which means downstream purification technology must continue to evolve and meet these productivity gains. During the last few years, the protein A chromatography resin step has started to become a rate-limiting step in many processes; if the efficiency of protein A resin is determining the efficiency of the entire manufacturing facility, it’s important to continue to innovate. And I think there is still room for improvement. For example, one key concern for both regulatory agencies as well as the biopharma industry is bioburden control. The protein A step is loaded with all the cell culture nutrients cells are grown in, which makes the load fraction coming onto the protein A resins highly likely to promote bacterial growth. In addition, as protein A resins have historically been less chemically resistant to sodium hydroxide, the most commonly used cleaning and sanitization agent, there is an elevated risk for microbial contamination. Such issues can be fixed with new technologies.
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