Bayer Evaluates Fibro For Scalable Single-Use mAb Purification

By Ryan Zolyomi, Ian Scanlon^#, Florence Rusly, Oliver Hardick^#, Ashley Hesslein, and Hendri Tjandra. Biological Development – Isolation & Purification, Bayer U.S. LLC, Pharmaceuticals and Cytiva^#

Capture on protein A chromatography resin gives excellent recovery and purity in clinical monoclonal antibody (mAb) manufacturing. However, compared with full-scale manufacturing, fewer cycles are necessary due to clinical batch sizes, so the full resin lifetime is rarely understood.

To realize its potential as a single-use mAb capture technology, Bayer worked with Cytiva to evaluate a fiber-based alternative, Fibro PrismA. Scalability from lab- to process-scale units, tracking pressure drop, step recovery, purity, and eluate volumes across multiple cycles were assessed.

It was found that there are several advantages to Fibro PrismA over other protein A capture alternatives. In addition, initial process modeling of Fibro chromatography indicates significant productivity gains with somewhat higher buffer consumption and eluate volumes compared with a protein A resin-based process.

Explore topic areas surrounding Fibro rapid cycling chromatography for bioprocess scale manufacturing, including evaluating productivity, facility fit, fit within existing platforms, scalability, and product quality. Manufacturing scenarios where Fibro PrismA could be a good fit are also discussed.