Made Scientific Integrating RoosterBio’s Mesenchymal Stem Cell Therapy Tech Into Its CDMO Offerings

Key Points

• Made Scientific and RoosterBio have formed a partnership to combine mesenchymal stem cell (MSC) and extracellular vesicle (EV) manufacturing platforms with GMP CDMO services.
• The companies say the integrated platform is intended to help therapy developers shorten development timelines, reduce supply and scale-up risk, and support commercial manufacturing.
• The partnership brings together RoosterBio’s off-the-shelf allogeneic (donor derived) MSC inputs and process know-how with Made Scientific’s Princeton-based GMP manufacturing, downstream processing, and regulatory support.

Partnership Scope

Made Scientific, a New Jersey-based cell therapy CDMO, and RoosterBio, a Maryland-based cell bioprocess and supply company, have announced they’re integrating each other’s technologies to help scale mesenchymal stem cell (MSC) and MSC-exosome manufacturing.

Made Scientific will use RoosterBio’s off-the-shelf MSCs, MSC expansion media, EV collection media, and related bioprocess expertise across its GMP operations. The companies say this creates a supply-secure manufacturing platform for developers working on advanced therapies that use MSCs and MSC-derived EVs.

The platform centers on GMP raw materials that include high-density allogeneic (donor derived) MSC working cell banks, xeno-free MSC expansion media, and chemically defined EV collection media.

Manufacturing and Operational Capabilities

The manufacturing setup supports both conventional and bioreactor-based production. Platform options include Corning CellSTACK, Eppendorf BioFlo 320, Sartorius Biostat STR, Terumo BCT Quantum Flex, and PBS Biotech vertical-wheel bioreactors.

Made Scientific said flask-based production currently supports up to 40xCS10 scale (for context, a CS10 is a 10-layer CellSTACK vessel used for large-scale cell manufacturing), and recent GMP projects yielded about 0.5 billion viable cells per CS10. The company also said technology transfer activities for single-use bioreactor production are advancing toward client readiness in the second quarter of 2026.

Downstream processing capabilities include EV purification through tangential flow filtration and column chromatography. Fill-finish options include manual and semi-automated filling, with vial and bag formats available.

The site includes modular cleanrooms designed to meet FDA and EU GMP Annex 1 standards, and the company’s in-house regulatory team supports programs from preclinical development through commercialization.

Regulatory Positioning

RoosterBio’s off-the-shelf cGMP master and working cell banks are derived from U.S.-sourced donor tissue under AATB, AABB, and FDA regulations and in accordance with 21 CFR 1271. The companies say this combined infrastructure is intended to reduce friction as sponsors move toward IND submission and later-stage clinical development.

“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.”

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