Made Scientific partners with RoosterBio on scalable MSC manufacturing

Made Scientific, a contract development and manufacturing organization (CDMO) headquartered in Princeton, New Jersey, has entered a strategic partnership with RoosterBio to expand scalable manufacturing capabilities for mesenchymal stem cell (MSC) and extracellular vesicle (EV)-based therapies.

According to the announcement, the collaboration integrates Maryland-based RoosterBio’s MSC cell banks, media systems, and process development expertise into Made Scientific’s 60,000 square-foot GMP manufacturing operations, creating an end-to-end platform spanning process development through commercial-scale production. The platform is intended to support developers working on advanced therapies that use MSCs and MSC-derived EVs while improving scalability, reducing development timelines, and lowering manufacturing costs.

Made Scientific said the partnership provides sponsors with a supply-secure manufacturing workflow designed to reduce process variability and streamline scale-up. Manufacturing options include both traditional and bioreactor-based systems, while downstream processing capabilities include tangential flow filtration and column chromatography for EV purification, according to the companies.

The companies contend the integrated platform supports multiple GMP manufacturing configurations and is intended to provide continuity from early development through commercial production without requiring significant process changes during scale-up.

The announcement follows Made Scientific's February collaboration with Streamline Bio to integrate AI-enabled robotics into CAR-T manufacturing workflows to improve scalability, consistency, and cycle times in GMP operations.