Repligen Corporation 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 andiafiltration (UF/DF), which is performed in nearly every biopharmaceutical manufacturing process to concentrate and purify drug. 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.