Purolite & Repligen Announce Commercial Launch of Novel CH1 Affinity Resin for the Purification of Specialized mAbs

Purolite and Repligen Corporation recently 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, added “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.

Purolite, an Ecolab company, is a leading manufacturer of healthcare, pharmaceutical and life science products, and ion exchange, catalyst, adsorbent and specialty resins for water and non-water applications. Headquartered in King of Prussia, Pa., with 40 sales offices in more than 30 countries, Purolite has ISO 9001-certified manufacturing facilities in the U.S., U.K., China and Romania. With a large technical sales team, five R&D centers and five manufacturing facilities, Purolite provides high-end, customized solutions to address some of the world’s most complex challenges. For more information, visit www.purolite.com.

A trusted partner at nearly three million customer locations, Ecolab (ECL) is the global leader in water, hygiene, and infection prevention solutions and services that help protect people, planet and business health. With annual sales of $13 billion and more than 47,000 associates, Ecolab delivers comprehensive science-based solutions, data-driven insights and world-class service to advance food safety, help maintain clean and safe environments, optimize water and energy use, and improve operational efficiencies and sustainability for customers in the food, healthcare, hospitality and industrial markets in more than 170 countries around the world. For more information, visit  www.ecolab.com.

Repligen Corporation is a global life sciences company that develops and commercializes highly innovative bioprocessing technologies and systems that enable efficiencies in the process of manufacturing biological drugs. We are “inspiring advances in bioprocessing” for the customers we serve; primarily biopharmaceutical drug developers and contract development and manufacturing organizations (CDMOs) worldwide. Our focus areas are Filtration and Fluid Management, Chromatography, Process Analytics and Proteins. Our corporate headquarters are located in Waltham, Massachusetts, and the majority of our manufacturing sites are in the US, with additional key sites in Estonia, France, Germany, Ireland, the Netherlands and Sweden. For more information, visit www.repligen.com.