Purolite and Repligen have launched Praesto 70 CH1, an agarose-based affinity resin for the purification of monoclonal antibodies (mAbs).
The 70μm (micron) resin combines Purolite’s jetted beads manufacturing process with Repligen’s ligand technology to address specialized mAb purification and has been co-developed by Ecolab company, Purolite and Repligen Corporation. The financials of the partnership have not been disclosed.
The ligand has been specifically designed to target molecules containing a Human IgG1 CH1 domain and the degree of interaction with other Fabs and IgG’s will vary with respect to antibody species and subclass.
“While for many years protein A has almost been used as a ‘one size fits all’ for the capture and purification of antibody therapies, the increasing complexity means many of our customers are adopting a toolbox approach, containing affinity resins with novel selectivity and binding capabilities,” a spokesperson for Purolite told BioProcess Insider.
According to the firm, CH1 70 is a high-capacity resin with the ability to achieve longer resin lifetimes, improving the overall process economy, providing up to double he capacity of current resins.
Furthermore, Purolite hopes the resin will bring a new offering to customers looking to improve sodium hydroxide resistance or those looking for more options to identify a suitable resin which can expedite the purification development process, reduce the overall number of purification stages, and the selectivity and resolution burden for the subsequent polishing steps.
This can help reduce the number of unit operations, reduce process time, raw material and buffer costs, delivering a robust and efficient manufacturing process.
“This allows our customers to be more efficient in addressing this ‘purification puzzle’ where what does not bind is as important as what does. In that regard CH1 can offer real advantages for the removal of over-expression of free light chain that can be encountered during manufacture of some bispecific or fragments,” the spokesperson said.
In other news, Purolite has expanded its US footprint through its fourth biologics resin manufacturing facility in Pennsylvania. The site will include resin production facilities, cleanrooms, laboratories and new office space.
Situated in Landenberg, the facility is expected to create 150 jobs in the next five years and will focus on the production of agarose chromatography resin for downstream mAbs and recombinant protein purification. It will support new modality purification across cell therapy, gene therapy and mRNA, and is Purolite’s sixth manufacturing site worldwide.
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