Celularity Enters Strategic Collaboration Agreement with BlueSphere Bio to Support Cell Therapy Manufacturing

Celularity Inc. (Nasdaq: CELU) announced on February 24, 2025, that it has entered into a Master Services Collaboration Agreement with BlueSphere Bio, Inc. The agreement, which is the company’s second collaboration of this kind, will leverage Celularity’s advanced cGMP manufacturing capabilities to support the production of BlueSphere Bio’s cell therapy products.

The collaboration will initially focus on manufacturing BlueSphere Bio’s novel T cell receptor (TCR) therapies at Celularity’s cGMP-ready facility in Florham Park, New Jersey. Under the terms of the agreement, Celularity will allocate dedicated staff and a portion of its 37,000-square-foot commercial manufacturing footprint to produce BSB’s TCR T cell therapies designed for the treatment of Acute Myelogenous Leukemia (AML) in both domestic and international markets. The scope of production encompasses comprehensive aspects of cell therapy manufacturing, including Chemistry, Manufacturing, and Controls (CMC) as well as Quality Assurance and Quality Control.

Robert J. Hariri, M.D., Ph.D., Celularity’s Chair and CEO, stated that the collaboration underscores the company’s commitment to using its manufacturing and process development expertise not only to support its own development programs but also to provide a flexible and innovative model for clients in need of high-quality GMP manufacturing services. Hariri emphasized that the relationship with BlueSphere Bio reflects the revenue generating potential of Celularity’s assets and positions the company to attract additional partnerships seeking transformative manufacturing solutions.

BlueSphere Bio, which is advancing T cell therapies for high-risk AML, will utilize Celularity’s infrastructure to support the production and oversight of its second cell therapy product. Keir Loiacono, CEO of BlueSphere Bio, highlighted the importance of reliable and flexible manufacturing in propelling a successful cell therapy program and expressed confidence in Celularity’s capabilities to meet the evolving demands of the industry.

The collaboration marks an important milestone for Celularity, reinforcing its position as a key partner in the cell therapy manufacturing sector and broadening the scope of its services in the rapidly evolving field of regenerative medicine. Forward-looking statements in the announcement indicate that both companies anticipate this strategic partnership will not only bolster the development of novel therapies but also open avenues for future collaborations.

Both Celularity and BlueSphere Bio are poised to advance innovative cell therapy programs, with the current collaboration representing a significant step in aligning manufacturing excellence with cutting-edge therapeutic development.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Celularity’s 8K filing here.

Celularity Company Profile

Celularity Inc, a clinical-stage biotechnology company, develops off-the-shelf placental-derived allogeneic cell therapies for the treatment of cancer, immune, and infectious diseases. It operates through three segments: Cell Therapy, Degenerative Disease, and BioBanking. The company's lead therapeutic programs include CYCART-19, an allogeneic CAR-T cell for the treatment of non-Hodkin's lymphoma (NHL) and mantle cell lymphoma (MCL); CYNK-001, an allogeneic unmodified natural killer cell that is in Phase I/II clinical trial for the treatment of acute myeloid leukemia (AML); and APPL-001, a genetically modified placental-derived mesenchymal-like adherent stromal cell for the treatment of Crohn's disease.