Aragen Bioscience, a leading Contract Research Development and Manufacturing Organization (CRDMO) for small molecules and biologics, and Getinge, a Swedish life sciences products and solutions provider, today announced the successful validation of latter's Single-Use Production Reactors (SUPR) for large-scale recombinant antibody production. This collaboration combines Aragen's expertise in biopharmaceutical manufacturing and Getinge's innovative single-use technology, enabling seamless production of large-scale batches.

The validation study was conducted at Aragen's state-of-the-art R&D facility in Morgan Hill, California. It demonstrated the SUPR Bioreactor's exceptional performance in generating high-quality recombinant antibodies. The reactor is designed to be a single-use alternative to traditional stainless-steel bioreactors at the pilot and production scale. This allows the upstream process to continue from research to production with one trusted single-use platform. R&D and process optimization performed in the AppliFlex ST or Applikon Bio can now be easily scaled up using the SUPR.

"We are thrilled to have collaborated with Getinge on this validation study This partnership showcases our commitment to providing our clients with cutting-edge technology and proven capabilities to accelerate their drug development programs said Dr. Subodh Deshmukh, CEO, Aragen Bioscience. “Getinge’s 50L and 250L single-use bioreactor platforms are now available at Aragen to support the growing demand for large-scale recombinant antibody production."

Timo Walvoort, Director of Research & Development, Getinge said “The collaboration with Aragen has been instrumental in the development of this best-in-class, next generation, single-use production bioreactor system. Through closely working together, we have developed the world's first single-use true bioreactor, with unparalleled ease-of-use. I look forward to many more fruitful collaborations with our friends at Aragen!”  

Ease of scaleup, from 2 Ltr to 50 Ltr to 250Ltr, is one of the most challenging aspects of bioproduction. Aragen scientists used their superior proprietary platform process to run in the SUPR system and achieved excellent results. Critical parameters, such as cell growth pattern, metabolites, osmolality, pH and production yield profiles remained steady throughout the scaleup.

The successful validation of the SUPR Bioreactor further cements Aragen's position as a trusted CDMO, capable of delivering high-quality biopharmaceutical products to its clients across the biotech, animal health, and biosimilar sectors.