RGEN Repligen Corp

Repligen Corporation (NASDAQ:RGEN), a life sciences company focused on bioprocessing technology leadership, today announced the launch of AVIPure® dsRNA Clear OPUS® columns, a groundbreaking solution designed to simplify and enhance the production of mRNA therapeutics and vaccines. This novel affinity chromatography offering marries Repligen’s breakthrough dsRNA purification resin with its flagship OPUS pre-packed columns. The AVIPure dsRNA Clear resin offers unmatched performance in the removal of double-stranded RNA (dsRNA) impurities from transcribed RNA. As the market for mRNA-based biologics has expanded, so has the critical need for better dsRNA removal, to enable the highest levels of drug efficacy in patients, while reducing or preventing any undesirable immune responses. The AVIPure dsRNA Clear OPUS columns directly address this need, with a convenient, closed system for mRNA manufacturers.

The AVIPure dsRNA Clear resin launch follows last week’s formal completion by Repligen of its acquisition of Tantti Laboratory Inc., announced on July 29, 2024.

Olivier Loeillot, President and Chief Executive Officer for Repligen said, “We are thrilled to be introducing this innovative technology to market. The AVIPure dsRNA Clear resin offering represents the initial of several planned Repligen-owned resin launches in 2025, that combine Tantti’s innovative DuloCore® bead technology with our AVIPure affinity ligands. Add on OPUS, and we believe this is just our first step toward building a portfolio of gold standard products for new modality purification.”

The AVIPure dsRNA Clear resin product combines our proprietary affinity ligands with Tantti’s DuloCore® base bead technology. The result is a 2-3 log reduction of dsRNA impurities in just one minute of residence time in flow through mode. Unlike traditional methods, this advanced solution eliminates the need for heat or solvents, providing an easy-to-use, scalable option for manufacturers, and enabling a highly efficient, cost-effective process that ensures the production of high-purity mRNA therapeutics and vaccines. Designed for flexibility and performance, the resins come pre-packed in OPUS chromatography columns, ensuring seamless integration into biomanufacturing workflows.

Umay Saplakoglu, Vice President of Product Management at Repligen said, “Our AVIPure dsRNA Clear OPUS columns will address one of the critical challenges in the production of mRNA therapeutics by providing a technology that combines speed, scalability and exceptional impurity removal while simplifying the workflow. This launch reaffirms our commitment to enabling our customers to deliver safe, high-quality biotherapeutics while reducing costs.”

For more information about AVIPure dsRNA Clear OPUS Columns, please visit Repligen's website.

About Repligen CorporationRepligen 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 in Waltham, Massachusetts, and the majority of our manufacturing sites are in the U.S., with additional key sites in Estonia, France, Germany, Ireland, the Netherlands and Sweden. For more information about the company see our website at www.repligen.com, and follow us on LinkedIn.

Forward Looking Statements This press release contains forward-looking statements within the meaning of the federal securities laws. Investors are cautioned that statements in this press release which are not strictly historical statements including, without limitation, express or implied statements or guidance regarding the impact of the AVIPure dsRNA Clear OPUS columns on Repligen’s future financial performance, customer adoption of the AVIPure dsRNA Clear OPUS columns, the expected expansion of Repligen’s product lines, and other statements identified by words like “believe,” “expect,” “may,” “will,” “should,” “seek,” or “could” and similar expressions, constitute forward-looking statements. Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated, as detailed in Repligen’s most recent Annual Report on Form 10-K, subsequently filed Quarterly Reports on Form 10-Q and the other reports that Repligen periodically files with the Securities and Exchange Commission. Actual results may differ materially from those Repligen contemplated by these forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. These forward-looking statements reflect management’s current views and are based only on information currently available to us. Repligen does not undertake to update, whether written or oral, any of these forward-looking statements to reflect a change in its views or events or circumstances, whether as a result of new information or otherwise, that occur after the date hereof except as required by law.

Repligen Contact:Sondra S. NewmanVP, Global Head of Investor Relations(781) 419-1881investors@repligen.com