Repligen Launches TangenX® SC as First-to-Market Holder-Free Self-Contained TFF Device

Rhea-AI Summary

Repligen Corporation has announced the commercial launch of TangenX SC, the industry's first holder-free, self-contained Tangential Flow Filtration (TFF) device. This technology is suitable for the manufacture of biologics, including ADCs, viral vectors, nucleic acids, and lipid nanoparticles. TangenX SC offers advantages such as significant time savings, reduced risk of product loss, scalability, and single-use, gamma sterilized design.

- Targeting ADC and Cell & Gene Therapy Customers -

WALTHAM, Mass., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Repligen Corporation (NASDAQ:RGEN), a life sciences company focused on bioprocessing technology leadership, today announced the commercial launch of TangenX® SC, the industry’s first holder-free, self-contained Tangential Flow Filtration (TFF) device. The technology is especially suited to the manufacture of biologics where fully closed systems are critical or ideal, including antibody drug conjugates (ADCs), viral vectors, nucleic acids and lipid nanoparticles, and can also be applied to monoclonal antibody, and recombinant protein production. TangenX SC is not only transformative, it is also a milestone achievement in the advancement of downstream flat sheet TFF technology for ultrafiltration and diafiltration (UF/DF), which is performed in nearly every biopharmaceutical manufacturing process to concentrate and purify drug.

Christine Gebski, Senior Vice President, Filtration and Chromatography at Repligen, said, “TangenX SC pushes the boundaries of TFF innovation, offering clear advantages to virtually any user of flat sheet TFF. The holder-free TangenX SC device simplifies and streamlines downstream flat sheet UF/DF processes like never before. Users can trust that the quality and consistency of their TFF processes remain uncompromised while enjoying the benefits of this innovative technology.”

Compared with traditional flat sheet TFF cassettes, “plug-and-play” TangenX SC self-contained devices offer several key advantages that drive significant efficiency and productivity gains:

• Significant time savings
  TangenX SC’s holder-free design and simplified assembly is demonstrated to reduce set up time by 80%. 
• Reduced risk of product loss
  The novel self-contained device eliminates holders and torquing requirements, reducing the risk of product loss caused by changes in compression or cassette misalignment during installation.
• Scalability
  TangenX SC devices scale from pilot to process scale. Designed with the same flow path length and channel geometry as traditional cassettes, TangenX SC allows users to seamlessly transition from traditional cassettes.
• Single-use, gamma sterilized
  TangenX SC devices are aseptically closed and gamma irradiated to reduce bioburden risk and permit use in Controlled not Classified (CNC) manufacturing environments. The closed design also enhances safety by isolating operators from potentially hazardous materials.

This next-generation technology provides Repligen’s biopharmaceutical manufacturing customers with an expanded selection of flat sheet TFF offerings, beyond its TangenX SIUS® and SIUS Gamma single-use cassettes and PRO reusable cassettes.

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 located 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, please visit www.repligen.com, and follow us on LinkedIn.

Forward-Looking Statements
This press release may contain 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, 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, including risks discussed from time to time in our filings with the Securities and Exchange Commission. We expressly disclaim any responsibility to update any forward-looking statements, except as required by law.

Contact:
Sondra S. Newman
Global Head of Investor Relations
investors@repligen.com
781-250-0111

FAQ

What is the name of the company mentioned in the press release?

The company mentioned in the press release is Repligen Corporation.

What is the name of the newly launched device?

The newly launched device is called TangenX SC.

What is the industry focus of Repligen Corporation?

Repligen Corporation is focused on bioprocessing technology leadership in the life sciences industry.

What are some applications of TangenX SC?

TangenX SC can be used in the manufacture of biologics such as antibody drug conjugates (ADCs), viral vectors, nucleic acids, and lipid nanoparticles. It can also be applied to monoclonal antibody and recombinant protein production.

What are the advantages of TangenX SC over traditional flat sheet TFF cassettes?

TangenX SC offers advantages such as significant time savings, reduced risk of product loss, scalability from pilot to process scale, and single-use, gamma sterilized design.