- Made Scientific will deploy multiple CARR Biosystems UniFuge single-use centrifugation systems at its Princeton, New Jersey, and East Norriton, Pennsylvania, facilities to support cell harvesting, washing, and concentration.
- The partnership will support the scale-up of mesenchymal stem cell (MSC) and feeder cell manufacturing, with Made Scientific equipping its East Norriton facility with 3D bioreactor platforms of up to 200 liters.
Made Scientific, Inc., a U.S.-based cell therapy contract development and manufacturing organization (CDMO), has partnered with CARR Biosystems to deploy multiple UniFuge single-use centrifugation systems across its facilities in Princeton, New Jersey, and East Norriton, Pennsylvania. The technology will support cell harvesting, washing, and concentration for 3D and large-scale manufacturing of mesenchymal stem cells (MSCs) and feeder cells as allogeneic cell therapy programs advance toward commercial supply.
The UniFuge platform uses low-shear tubular bowl centrifugation for cell concentration, washing, media exchange, harvesting, and formulation. Its single-use systems cover process volumes ranging from milliliters to more than 2,000 liters. The platform also offers automated operation, rapid changeover, and a data trail compliant with 21 CFR Part 11. Made Scientific will integrate the systems into its existing development and good manufacturing practice (GMP) workflows.
The deployment will support Made Scientific’s expansion of 3D bioreactor manufacturing capacity at its East Norriton facility, where platforms of up to 200 liters are being introduced. The company said the technology will provide a closed, automated separation step for its MSC and feeder cell processes. The partnership is also intended to help transfer processes from development to larger-scale GMP manufacturing while supporting comparability and reducing scale-up risk.
The companies plan to conduct joint development studies using CARR’s benchtop UFMini system to generate small-scale data that can be carried forward to larger volumes. Made Scientific will also serve as a preferred CDMO for CARR customers evaluating the platform. The collaboration builds on Made Scientific’s MSC and extracellular vesicle (EV) offerings established through its partnership with RoosterBio, which has integrated UniFuge into its bioprocess engineering and process development capabilities.
“Allogeneic therapies reach patients at commercial scale only when the whole process scales, not just the bioreactor. Integrating UniFuge across the company’s two facilities would give clients a closed and automated processing option from development through commercial supply.”
Syed T. Husain, chairman and CEO of Made Scientific
CARR Biosystems President Joel Williams said the companies’ capabilities align in supporting cell therapy developers as they scale manufacturing processes.
