Next-Generation At-Line Concentration Measurement for Bioprocessing

WALTHAM, Mass., Jan. 06, 2025 (GLOBE NEWSWIRE) -- Repligen Corporation (NASDAQ:RGEN), a life sciences company focused on bioprocessing technology leadership, today announced the commercial launch of its CTech SoloVPE PLUS System, the most advanced UV-based Variable Pathlength Technology system now available to biopharmaceutical manufacturers. The SoloVPE PLUS System is engineered to offer unparalleled accuracy, speed, and ease-of-use for at-line ultraviolet-visible (UV-Vis) concentration measurement in complex biological production workflows, from process development scale through cGMP manufacturing.

As the bioprocess industry shifts toward higher drug concentration formulations to improve efficiency and reduce production costs, there has been a growing need for faster, more reliable and more accurate analytical tools. The SoloVPE PLUS System addresses this need, utilizing variable pathlength spectroscopy to deliver precise concentration measurements in under 30 seconds, without the need for dilution or background correction.

This innovative technology is a significant addition to Repligen's process analytics portfolio, advancing the company's at-line capabilities and complementing both its in-line, real-time FlowVPX System and fully integrated RPM (Real-time Process Management) TFF Systems. Applications for the SoloVPE PLUS System include measurement of protein concentration (such as for antibody-based drugs, including ADC drug-to-antibody ratio), quantitation of nucleic acids (DNA/RNA) and measurement of mRNA in mRNA-based therapeutics.

Olivier Loeillot, President and Chief Executive Officer at Repligen said, "The next-generation SoloVPE PLUS System is a success for our development team, delivering on the goal to achieve a new level of speed, precision and reproducibility. It's an exciting advance for Repligen - and just the first of many new product launches we have planned for 2025."

Kola Otitoju, Senior Vice President and Global Head of Process Analytics, said, "Repligen is at the forefront of PAT innovation, and the new SoloVPE PLUS System showcases our ability to evolve our bioprocessing technologies to meet our customers' needs. The SoloVPE PLUS System delivers on the key performance factors required to support faster decision-making and greater efficiency, helping our customers improve both their productivity and bottom line."

The SoloVPE PLUS System offers several key advantages over current UV-Vis spectroscopy offerings in the market:

• Streamlined Workflow. Reduces process steps by 70%, from a seven-step process to just two - measure and report.
• Accelerated Acquisition Speed. Doubles the speed of data collection, delivering results in half the time compared to the legacy SoloVPE System.
• Enhanced Sensitivity and Reproducibility. Measures the widest range of concentrations without dilution—mAbs from 0.01 mg/mL to 320 mg/mL, with an R2≥ 0.999.
• Minimized Error-Prone Steps. Direct measurement of samples eliminates the need for dilution or additional sample preparation.
• Optimized Data Management. The CTech ViPER ANLYTX Software integrates SQL for data storage and retrieval, and OPC-UA for standardized communication, enabling a streamlined, agile, and connected system that supports real-time access and scalable bioprocessing operations.
  

About Repligen Corporation
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 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 , 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 SoloVPE PLUS systems on Repligen's future financial performance, customer adoption of the SoloVPE PLUS, 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. Newman
VP, Global Head of Investor Relations
(781) 419-1881
investors@repligen.com

A photo accompanying this announcement is available at