Purolite and Repligen announce the commercial launch of a novel CH1 affinity resin for the purification of specialized mAbs

King of Prussia, PA, US and Waltham, MA, US  – (Feb 6, 2024)  Purolite, an Ecolab company a leading manufacturer of synthetic and agarose-based bioprocessing resins, and Repligen Corporation (NASDAQ:RGEN), a life sciences company focused on bioprocessing technology leadership, today announced the commercial launch of Praesto^® CH1,  a new 70μm (micron) agarose-based affinity resin designed to purify specialized mAbs such as bispecifics and recombinant antibody fragments. This latest innovation, which was developed for commercialization by Purolite as part of a multi-year strategic partnership with Repligen, combines Purolite’s patented Jetted beads manufacturing process with Repligen’s leading ligand technology to address previously unmet challenges in specialized mAb purification.

The new CH1 purification resin builds on the success of Purolite’s current protein A resin portfolio, demonstrating high selectivity for antibodies and related fragments containing the human CH1 domain. This allows for the capture of bispecific antibodies and antibody fragments, as well as the removal of mis-paired species, providing an effective alternative for the purification of antibody variants when protein A resins are not suitable. Praesto CH1 delivers high productivity and a lower cost of goods to the bioprocessing market.

Purolite’s Vice President of Research and Development, Jennifer Sorrells said, “The launch of Praesto CH1 represents the latest offering in Purolite’s growing innovation toolbox for the purification of biologics. Our strategic partnership with Repligen brings leading technologies together to unlock new purification strategies that address our customers’ increasingly diverse biotherapeutic molecules, and the unique purification challenges that these can present.

Ralf Kuriyel, Senior Vice President of Research and Development at Repligen said, “It’s fantastic to see the Praesto CH1 resin come to market through our partnership with the Purolite team. We continue to make real advances in our Proteins franchise, supporting the success of the Praesto family of resins as Purolite’s exclusive development and manufacturing scale-up partner. This cross-linked agarose-based resin was specifically and successfully engineered for high dynamic binding capacity to the CH1 region of antigen-binding fragments from human immunoglobins (IgGs) and monoclonal antibodies (mAbs), and we believe it is particularly well positioned for market success.”

The announcement of Purolite’s latest resin innovation reinforces the company’s commitment to product expansion and innovation and follows news of its investment in a new bioprocessing production facility based in Landenberg, PA. The new production facility will be Purolite’s fourth location in Pennsylvania, further solidifying its commitment to meeting the needs of customers globally by providing dual-continent agarose manufacturing.