Aragen & Getinge’s SUPR bioreactors scale antibody production from 2L to 250L

Successful GMP validation of 50L and 250L SUPRs promises to transform biopharmaceutical manufacturing, offering seamless scale-up from research to production

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New Delhi: In a significant advancement for the biopharmaceutical industry, Aragen Bioscience and Getinge have successfully validated the latter’s Single-Use Production Reactors (SUPRs) for large-scale recombinant antibody production.
The collaboration, announced on June 4, 2024, merges Aragen’s biopharmaceutical manufacturing expertise with Getinge’s innovative single-use technology, offering a game-changing solution for seamless, large-scale batch production.
The validation study, conducted at Aragen’s cutting-edge R&D facility in Morgan Hill, California, showcased the SUPR Bioreactor’s exceptional performance in generating high-quality recombinant antibodies. Designed as a single-use alternative to traditional stainless-steel bioreactors at pilot and production scales, the SUPR allows the upstream process to continue from research to production using one trusted single-use platform. Moreover, R&D and process optimization performed in the AppliFlex ST or Applikon Bio can now be easily scaled up using the SUPR.
Dr. Subodh Deshmukh, CEO of Aragen Bioscience, expressed, “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.” He said, “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 at Getinge, echoed this sentiment, 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!”  
One of the most challenging aspects of bioproduction is scaling up from small lab-scale volumes to larger production volumes. Aragen scientists tackled this challenge head-on, using their superior proprietary platform process in the SUPR system with excellent results. Critical parameters such as cell growth pattern, metabolites, osmolality, pH, and production yield profiles remained steady throughout the scale-up from 2L to 50L to 250L.
This successful validation further solidifies Aragen’s status as a trusted Contract Research Development and Manufacturing Organization (CRDMO). It demonstrates their capability to deliver high-quality biopharmaceutical products to clients across various sectors, including biotech, animal health, and biosimilars.