GMP-compliant 50L and 250L SUPRs support large-scale recombinant antibody production
Aragen Bioscience, a Contract Research Development and Manufacturing Organisation (CRDMO) for small molecules and biologics, and Getinge, a Swedish life sciences products and solutions provider, recently announced the 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 R&D facility in Morgan Hill, California. It demonstrated the SUPR Bioreactor’s 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. According to the statement, this allows the upstream process to continue from research to production with one trusted single-use platform. R&D and process optimisation performed in the AppliFlex ST or Applikon Bio can now be easily scaled up using the SUPR.
“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 statement adds.