Made Scientific and RoosterBio Announce Strategic Technology and Supply Partnership to Expand Scalable MSC and Extracellular Vesicle Manufacturing

Partnership integrates RoosterBio's mesenchymal stem cell and extracellular vesicle platforms into Made Scientific's end-to-end CDMO capabilities to accelerate development and commercial-scale production of advanced therapies

PRINCETON, N.J. and FREDERICK, Md., May 5, 2026 /PRNewswire/ -- Made Scientific, Inc., a U.S.-based clinical and commercial cell therapy contract development and manufacturing organization (CDMO), and RoosterBio, Inc., a leading supplier of human mesenchymal stem cells (MSCs), engineered bioprocess media, and bioprocess development services, today announced a strategic partnership integrating RoosterBio's mesenchymal stem cell (MSC) and extracellular vesicle (EV) manufacturing platforms into Made Scientific's end-to-end CDMO offering which spans from initial process development through commercial-scale GMP manufacturing.

Under the agreement, Made Scientific will incorporate RoosterBio's off-the-shelf MSCs, proprietary MSC expansion and EV collection media, and bioprocess know-how across its GMP operations, establishing a commercially viable manufacturing platform for sponsors developing advanced therapies that utilize MSCs and MSC-derived EVs. The integrated platform is designed to accelerate development timelines, improve cost of goods, and support programs at every stage of clinical and commercial advancement.

A differentiated, supply-secure platform

The manufacturing collaboration pairs GMP raw material inputs, including high-density, bioprocess-ready allogeneic MSC working cell banks, xeno-free MSC expansion media, and chemically defined EV collection media — all engineered for scalable manufacturing to deliver consistent doubling kinetics, reproducible potency across donors, and substantially greater productivity than legacy serum-based or research-grade systems. For sponsors, this means shorter process development cycles, fewer lot-to-lot deviations, and lower commercial-scale cost of goods. Combined with Made Scientific's GMP infrastructure in Princeton, NJ, the partnership delivers a single, de-risked supply chain from development through GMP commercial manufacturing, without the platform changes, requalification requirements, or supply uncertainty that typically accompany scale-up.

Manufacturing scale and downstream capabilities

Manufacturing platform options available support both conventional- and bioreactor-based processes, including Corning CellSTACK® (CS), Eppendorf BioFlo® 320, Sartorius Biostat STR®, Terumo BCT Quantum Flex™, and PBS Biotech vertical-wheel bioreactors. Flask-based production currently supports up to 40xCS10 scale, with ongoing technology transfer activities for single-use bioreactor production advancing toward client readiness in Q2 2026. Made Scientific has successfully manufactured GMP MSC lots for global customers since the initiation of tech transfer activities in Q3 2025, with recent GMP campaigns yielding approximately 0.5 billion viable cells per CS10. Downstream processing includes extracellular vesicle purification via tangential flow filtration (TFF) and column chromatography. Multiple fill-finish options are available, including manual and semi-automated filling, with flexibility to meet a range of container-closure configurations in vial and bag format.

Operations and regulatory readiness

Made Scientific operates a 60,000-square-foot FDA registered GMP manufacturing facility in Princeton, NJ, purpose-built for clinical and commercial cell therapy production. Flexible, modular cleanrooms are designed to meet U.S. FDA and EU GMP Annex 1 compliance standards, and an in-house regulatory team supports clients from preclinical development to commercialization. Through this partnership, Made Scientific has integrated RoosterBio's MSC and EV established process know-how into its GMP workflows, providing sponsors a seamless pathway from process development at RoosterBio's Frederick, MD laboratories to GMP manufacturing and capacity assurance at Made Scientific's Princeton site.

RoosterBio cGMP products have been incorporated in over 25 clinical trials and are supported by FDA type II master files and international regulatory support dossiers. RoosterBio's off-the-shelf cGMP master and working cell banks are derived from US-sourced donor tissue per AATB, AABB, and FDA regulations and in accordance with 21CFR1271.   

This combined experience creates a derisked path to IND approval and subsequent clinical advancement. "This partnership gives our clients a fully integrated, scientifically rigorous pathway from development through commercial supply — combining RoosterBio's proven MSC platform with Made Scientific's GMP manufacturing, quality systems, and regulatory expertise," said Syed T. Husain, Chairman & CEO of Made Scientific. "It directly addresses what sponsors need to advance MSC programs to commercialization."

"Made Scientific has demonstrated a clear commitment to manufacturing excellence and a genuine understanding of what it takes to bring cell therapies from development into commercial reality," said Tim Kelly, CEO of RoosterBio. "Integrating our MSC and EV manufacturing platforms into Made Scientific's CDMO infrastructure gives advanced therapy developers access to a proven, scalable manufacturing platform and accelerates the path to commercially viable MSC-based therapeutics."

With established global reach, Made Scientific and RoosterBio aim to strengthen the manufacturing ecosystem with an industry leading solution for MSC and EV therapy developers and support the growing global demand for scalable, GMP-compliant advanced therapy production.

About Made Scientific

Made Scientific is a U.S.-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, and release of autologous and allogeneic cell therapy products for clinical and commercial supply. Headquartered in Princeton, New Jersey, Made Scientific combines the agility of a specialist CDMO with the deep technical expertise to deliver reliable and scalable solutions, supported by their long-term strategic backer, GC Corporation, a global leader in the pharmaceutical and biotechnology sectors. For more information, visit madescientific.com.

About RoosterBio

RoosterBio is a Frederick, Maryland–based biotechnology company and a leading supplier of human mesenchymal stem/stromal cells (hMSCs), engineered media, and scalable bioprocess systems. Its off-the-shelf cells, media, and bioreactor kits streamline manufacturing workflows and enable commercially viable processes, helping cell and exosome therapy developers accelerate programs from R&D to GMP. For more information, visit www.roosterbio.com.

Media Contact

Made Scientific:

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RoosterBio:

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SOURCE Made Scientific, Inc.