Made Scientific, Inc., a Princeton-based cell therapy contract development and manufacturing organization (CDMO), and RoosterBio, a Maryland-based supplier of human mesenchymal stem cells (MSCs) and bioprocess systems, on Tuesday announced a partnership to accelerate the commercial-scale production of advanced therapies.
The collaboration integrates RoosterBio’s specialized MSC and extracellular vesicle (EV) manufacturing platforms into Made Scientific’s end-to-end CDMO capabilities. This offering spans from initial process development at RoosterBio’s Frederick, MD laboratories to large-scale GMP manufacturing at Made Scientific’s 60,000-square-foot facility in Princeton.
Under the new agreement, Made Scientific will incorporate RoosterBio’s proprietary MSC expansion media, EV collection media, and off-the-shelf cell banks into its GMP operations. This creates a de-risked, commercially viable manufacturing platform designed to shorten development timelines and significantly reduce the cost of goods for sponsors.
“This partnership gives our clients a fully integrated, scientifically rigorous pathway from development through commercial supply,” Syed Husain, chairman & CEO of Made Scientific said. “It directly addresses what sponsors need to advance MSC programs to commercialization by combining RoosterBio’s proven platform with our GMP infrastructure and regulatory expertise.”
The partnership addresses a critical pain point in the industry: the transition from research-grade systems to scalable, GMP-compliant manufacturing. Key features of the collaborative platform include:
- High-Density Cell Banks: Bioprocess-ready allogeneic MSC working cell banks designed for consistent kinetics.
- Advanced Media Systems: Xeno-free expansion and chemically defined collection media for superior productivity compared to legacy serum-based systems.
- Flexible Scale: Support for conventional CellSTACK® systems as well as advanced bioreactors from Sartorius, Eppendorf, and Terumo BCT.
- Downstream Excellence: Advanced purification via tangential flow filtration (TFF) and column chromatography for EVs.
Made Scientific’s Princeton facility is purpose-built for clinical and commercial cell therapy production, designed to meet both U.S. FDA and EU GMP Annex 1 standards. By integrating RoosterBio’s products—which have already been utilized in over 25 clinical trials and are supported by FDA Type II Master Files—the partnership offers a seamless regulatory pathway for sponsors.
“Made Scientific has demonstrated a clear commitment to manufacturing excellence,” Tim Kelly, CEO of RoosterBio said. “Integrating our platforms into their infrastructure gives developers access to a proven, scalable platform and accelerates the path to commercially viable therapeutics.”
Together, Made Scientific and RoosterBio aim to strengthen the global cell therapy ecosystem, providing a robust solution for developers facing the growing demand for scalable, high-quality advanced therapy production.
