Improving Downstream Purification Performance For Monoclonal Antibodies (mAbs)

Source: Avantor

Avantor’s high purity protein A resin, J.T.Baker® BAKERBOND® PROchievA™, and expanded line of J.T.Baker® BAKERBOND® process chroma resins bring choice and efficiency to monoclonal antibodies (mAbs) manufacturing processes and protocols—from the lab to production setting.

As biopharmaceutical manufacturers pursue ways to optimize monoclonal antibodies (mAbs) production to gain process efficiencies while reducing costs, many opportunities remain to drive costs out of downstream production. Today, the collective set of downstream process steps account for approximately 60% of the total cost of production.

Unlike upstream processing, downstream production involves added complexity: the biological material is moved from harvest, centrifugation and polishing, then to multiple chromatography steps. Protein A chromatography is a proven, critical chromatography  capture step of mAbs manufacturing that happens first, followed by polishing steps. A unique set of resins, buffers and other materials are used as the product passes through these stages before reaching final fill and finish.

Launched in 2020, Avantor’s recombinant Protein A chromatography resin, J.T.Baker® BAKERBOND® PROchievA™, addresses challenges of reducing total purification costs while improving purity and yield.

“Biopharmaceutical developers and manufacturers are urgently seeking new tools to drive more efficiency in their production processes,” said Dr. Ger Brophy, Executive Vice President for Biopharma Production at Avantor. “But they cannot compromise on quality standards as they work to provide powerful medicines to patients in a timely, safe and efficient manner.”

The J.T.Baker® BAKERBOND® PROchievA™ recombinant protein A resin is an affinity resin that bonds to the Fc region of the target mAb. In performance tests conducted against other best-in-class Protein A resins on the market today, Avantor’s novel BAKERBOND® PROchievA™ resin demonstrated high performance and best-in-class purification. Avantor’s resin is compatible with current manufacturing standards to ensure continuity in workflow processes and compliance protocols.

The BAKERBOND® PROchievA resin was shown to deliver higher levels of protein purity post-protein A chromatography, thus reducing the burden on subsequent purification operations.

“Our PROchievA™resin provides customers with a best-in-class, high-performing alternative to existing purification technology, with the benefit of greater supply chain flexibility and security.” added Dr. Brophy.

Recently, Avantor introduced a new range of lab columns for additional BAKERBOND® process chromatography resins. Along with the BAKERBOND® PROchievA™ resin, these resins enhance the Avantor J.T.Baker® family of advanced chemicals, excipients, chromatography media and resin products for biopharmaceutical research and production.

BAKERBOND® process chromatography resins allow biopharma manufacturers to realize higher production efficiencies, meet stringent regulatory requirements and accelerate regulatory approval in bringing new therapies to market. They are delivered in a nonhazardous, nonflammable buffer solution as a standard offering which helps reduce or eliminate costs of special handling and storage.

BAKERBOND® resin products are delivered in a nonhazardous, nonflammable buffer solution as a standard offering.

Get more information about the J.T.Baker® BAKERBOND® PROchievA™ resin and other J.T.Baker® chromatography products: