Celularity to Manufacture MuseCell Innovations Therapies in the US
The initial program will use qualified perinatal starting materials and the licensed Dezawa Method, with product-specific testing and release criteria.
Key Points
- Celularity and MuseCell Innovations plan to establish U.S. production of Dezawa MuseCells at Celularity’s New Jersey facility.
- The initial program will use qualified perinatal starting materials, the licensed Dezawa Method, and product-specific testing and release criteria.
- The collaboration also covers Dezawa MuseExosomes and Dezawa MuseSecretome, with a broader manufacturing relationship planned after the initial project.
Celularity and MuseCell Innovations (MCI), owner of the Dezawa MuseCell platform, announced a manufacturing collaboration to establish U.S. production of Dezawa MuseCells (DMCs) at Celularity’s facility in Florham Park, New Jersey. The collaboration initially focuses on qualified perinatal sources.
The initial program is designed to establish manufacturing capability for MCI-authenticated DMC preparations. Under the platform, DMC products are manufactured from qualified perinatal, bone marrow, or adipose starting material using the licensed Dezawa Method and MCI product specifications.
The collaboration also encompasses DMC-derived products, including Dezawa MuseExosomes and Dezawa MuseSecretome. Each product will have dedicated manufacturing processes, analytical characterization, specifications, and release criteria based on its product profile.
Following completion of the initial project, the companies intend to pursue a broader manufacturing relationship covering additional products and programs. Based on current market conditions and its projections for the platform, MCI estimates that the expanded relationship could result in more than $300 million in aggregate purchases from Celularity over five years.
“Cellular medicine remains at the center of Celularity’s strategy, including our continued advancement of our proprietary placental-derived technologies,” said Robert J. Hariri, M.D., Ph.D., Founder, Chairman and Chief Executive Officer of Celularity. “Our collaboration with MCI demonstrates how the manufacturing infrastructure and cellular expertise we have built can also support innovative third-party technologies. We look forward to expanding U.S. manufacturing for the Dezawa MuseCell platform and working with MCI to manufacture additional products derived from the platform.”
Manufacturing Capacity
Celularity operates a 147,215-square-foot facility in Florham Park. Its cGMP-ready manufacturing center includes nine Grade C/ISO 7 suites and six Grade D/ISO 8 suites designed for commercial production of cellular therapies and advanced biomaterials.
The company’s capabilities include process development, product-specific chemistry, manufacturing and controls (CMC), cell manufacturing, analytical methods, and quality systems. Celularity also continues to develop cenplacel-L, its placental-derived allogeneic (donor derived) cell therapy.
The companies anticipate that a broader manufacturing collaboration could create more than 200 positions at the Florham Park site. The projected roles would include positions in biomanufacturing, quality control, engineering, and support functions.
Dezawa Method and Source Qualification
Professor Mari Dezawa, M.D., Ph.D., discovered Muse cells as a naturally occurring, stress-enduring cell population. The companies said Muse cell biology and investigational applications have been described in more than 170 peer-reviewed publications and evaluated in multiple human clinical studies.
The Dezawa MuseCell platform combines qualified starting materials with the licensed Dezawa Method and MCI specifications for identity, purity, viability, potency, traceability, and lot release. This manufacturing and quality framework is intended to maintain defined DMC identity across qualified bone marrow, adipose, and perinatal sources while allowing source-specific biological characteristics to be evaluated and controlled.
“I discovered Dezawa MuseCells as a naturally occurring, stress-enduring cell population,” said Professor Mari Dezawa, M.D., Ph.D., Chair of MCI’s Scientific Advisory Board. “As manufacturing expands across qualified tissues, reproducibility depends on preserving the Dezawa Method and the defining product characteristics on which the platform was developed. Celularity provides an important opportunity to scale that approach in the United States, adding another home to the DMC global production.”
Quality and Traceability
MCI’s platform is designed to document source qualification, manufacturing authorization, lot-level testing, and chain of custody through authorized distributors. The collaboration is intended to expand MCI’s U.S. manufacturing network while maintaining product-specific quality controls.
The framework also distinguishes MCI-authenticated DMC products from unverified SSEA-3-positive preparations manufactured outside the licensed Dezawa Method and MCI’s release requirements.
Neither cenplacel-L nor any MCI product described in the release has been approved or licensed by the FDA for any indication or use.
Want to keep up on regenerative medicine? Get the weekly newsletter here.
