Made Scientific and RoosterBio Forge Partnership to Revolutionize MSC and EV Manufacturing

Strategic Partnership to Advance MSC and EV Production

In a significant move within the biotechnology sector, Made Scientific, a leading U.S.-based cell therapy contract development and manufacturing organization (CDMO), has announced a strategic partnership with RoosterBio, a premier supplier of mesenchymal stem cells (MSCs). This collaboration is set to integrate RoosterBio’s MSC and extracellular vesicle (EV) manufacturing platforms into Made Scientific’s comprehensive CDMO services, which span from initial development to large-scale production.

Enhancing Manufacturing Capabilities

The partnership will see Made Scientific incorporate RoosterBio's off-the-shelf MSCs and specialized media for MSC expansion and EV collection into its current Good Manufacturing Practice (GMP) operations. This integration promises to establish a viable manufacturing ecosystem for clients developing advanced treatments utilizing MSCs and MSC-derived EVs. By simplifying and streamlining the process, both companies aim to reduce development timelines and costs while ensuring a high-quality output throughout all stages of production.

A Comprehensive Manufacturing Solution

The collaboration is built around a differentiated supply chain that combines GMP raw materials, such as high-density MSC working cell banks and xeno-free MSC expansion media. This state-of-the-art infrastructure allows for scalable manufacturing, ensuring consistent results and greater productivity compared to older systems dependent on serum or research-grade components. For sponsors, this translates to faster development cycles, lower costs, and a significant reduction in the variability often seen with traditional manufacturing methods.

Versatile Production Options

Made Scientific's advanced manufacturing options support both traditional and bioreactor-based systems, incorporating technologies like Corning CellSTACK®, Eppendorf BioFlo® 320, and Sartorius Biostat STR®. Currently, the flask-based production can achieve a scale of up to 40 times CellSTACK 10, with ongoing advancements aimed at client readiness in the second quarter of 2026. Since the commencement of tech transfer activities in Q3 2025, Made Scientific has produced GMP-compliant MSC lots, yielding approximately 0.5 billion viable cells per production cycle.

Regulatory Compliance and Readiness

Operating from a 60,000-square-foot FDA-registered GMP facility in Princeton, New Jersey, Made Scientific is equipped for both clinical and commercial cell therapy production. The cleanroom environments are designed to align with U.S. FDA and EU GMP Annex 1 standards. Significantly, the partnership incorporates RoosterBio's established methodologies into Made Scientific's workflow, facilitating a seamless transition from development in Frederick, Maryland, to GMP manufacturing in Princeton.

The products developed under this collaboration have already been utilized in over 25 clinical trials globally, showcasing RoosterBio's impressive regulatory support and adherence to industry standards.

A Pathway to Innovation

This partnership is poised to set a new benchmark in the manufacturing of advanced cellular therapies. As manufacturers face increasing pressure to deliver MSC-based therapies efficiently, the collaboration between Made Scientific and RoosterBio creates a robust, scalable platform catered to meet growing demands.

Syed T. Husain, Chairman and CEO of Made Scientific, shared, "This partnership gives our clients a fully integrated, scientifically rigorous pathway from development through commercial supply. It directly addresses the challenges sponsors face in advancing MSC programs towards commercialization."

Tim Kelly, CEO of RoosterBio, echoed this sentiment, emphasizing that the collaboration enables therapy developers to access a reliable manufacturing platform, thereby accelerating the journey towards commercially viable MSC therapies.

The strategic alignment of Made Scientific and RoosterBio represents a forward-thinking initiative aimed at enhancing the manufacturing landscape for MSCs and EV therapies, ultimately benefiting the global health sector.

For further details, visit Made Scientific and RoosterBio.