Celularity and MuseCell to establish U.S. manufacturing for the Dezawa MuseCell platform
Celularity and MuseCell are preparing to manufacture Muse cell products in New Jersey using a licensed method and defined specifications
On August 27, Celularity and MuseCell Innovations, the company developing the Dezawa MuseCell platform, announced an initial project at Celularity’s facility in Florham Park, New Jersey. The partners will transfer the technology, develop the manufacturing process, and prepare for production of Dezawa MuseCells (DMC).
Each batch of a cell product must have documented source material, manufacturing procedures, and release test results. These records make it possible to trace the batch and compare it with others.
In their press release, the partners define DMC as a product derived from qualified perinatal tissue, bone marrow, or adipose tissue and manufactured according to the licensed Dezawa method and MuseCell specifications. Before release, each batch is expected to undergo testing to confirm its identity and purity, viability, required function, and traceability to its source. These criteria provide a common set of rules for releasing DMC derived from different source materials.
A cell batch may remain viable and retain the surface marker proteins used to identify the cell type, yet lose some of the function for which it is used in tissue repair. This risk was discussed in a review of cells being studied for tissue repair. DMC functional activity was therefore included in release testing alongside cell identity and purity.
Celularity’s infrastructure covers process development, cell manufacturing, analytical methods, and quality control. The project also includes DMC derivatives: exosomes, which are small vesicles released by cells into their surroundings, and the secretome, which comprises the substances secreted by a cell. The partners plan to establish separate manufacturing processes, characterization tests, and release criteria for these products.
These standards are needed before clinical trials begin. In a 2024 prospective multicenter study, ten people with cervical spinal cord injuries received a single intravenous dose of CL2020, another Muse product. The primary objective was to assess safety and feasibility. The new Celularity and MuseCell program establishes the standards that will govern the manufacturing and testing of future DMC batches before similar studies.