Celularity Inc. (Nasdaq: CELU) (“Celularity”), a longevity-focused regenerative and cellular medicine company, and MuseCell Innovations® Pte. Ltd. (“MCI”), the owner of the Dezawa MuseCell platform, today announced an additional U.S.-based manufacturing collaboration under which Celularity will undertake activities to establish U.S. production of Dezawa MuseCells (“DMCs”) at Celularity’s Florham Park, New Jersey facility.
The initial program is designed to establish manufacturing capability for MCI-authenticated DMC preparations. Under the MCI platform, a preparation is authenticated as a DMC product through perinatal, bone marrow or adipose qualified starting material, manufactured under the licensed Dezawa Method and conformance to MCI’s product specifications. In addition to DMC manufacturing, the collaboration encompasses the manufacture of DMC-derived products, including Dezawa MuseExosomes and Dezawa MuseSecretome. Each product will be supported by dedicated manufacturing processes, analytical characterization, specifications and release criteria appropriate to its distinct product profile.
Following successful completion of the initial project, Celularity and MCI intend to build a broader manufacturing relationship across additional products and programs. Based on current market conditions and MCI’s projections for the Dezawa MuseCell platform, MCI believes that the expanded relationship could result in more than $300 million in aggregate purchases from Celularity over the next five years. This estimate reflects the potential scope of future programs beyond the initial project, which the parties would pursue together as the collaboration develops.
“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.”
“The ability to manufacture advanced cellular technologies reproducibly and at scale is fundamental to the future of medicine,” said Peter H. Diamandis, M.D., Co-Founder and Director of Celularity. “Bob Hariri and Mari Dezawa are both pioneers in cell therapy, and this collaboration brings together their complementary scientific vision and expertise. Celularity has invested in the infrastructure and capabilities required to manufacture sophisticated cellular products, both to advance our own placental-derived technologies and to support innovators such as MCI. This collaboration demonstrates how pioneering science, paired with scalable manufacturing, can accelerate the continued advancement of cellular medicine.”
Celularity operates a 147,215-square-foot, purpose-built facility in Florham Park, New Jersey, which includes a cGMP-ready manufacturing center with nine Grade C/ISO 7 and six Grade D/ISO 8 manufacturing suites designed for commercial production of cellular therapies and advanced biomaterials. Celularity’s integrated capabilities include process development, product specific chemistry, manufacturing and controls (CMC), advanced cell manufacturing, analytical methods and quality systems. The collaboration expands the utilization of Celularity’s manufacturing infrastructure and cellular medicine expertise while Celularity continues to advance its own proprietary cellular medicine programs, including cenplacel-L, its placental derived allogeneic cell therapy. The subsequent broader manufacturing collaboration is anticipated to generate more than 200 high-tech employment opportunities at the Florham Park site during the scope of the expanded collaboration, spanning specialized positions in biomanufacturing, quality control, engineering and support functions.
“By bringing a $300 million in business and more than 200 new jobs to New Jersey, Celularity and MuseCell Innovations are making it clear that our state is open for business. I first visited Celularity in 2022, and its trajectory from a homegrown startup here in New Jersey to a thriving public company is everything that drives my optimism about the potential of the New Jersey innovation economy. Advanced biomanufacturing continues to grow as a strong pillar of our economy, and investments like this are critical to driving job growth across our state. New Jersey is the medicine chest of the world, and my administration will keep working to make our government more accountable for businesses and position our state as the global leader in life sciences,” said New Jersey Governor Mikie Sherrill.
A Source-Flexible Platform Defined by the Dezawa Method
Professor Mari Dezawa, M.D., Ph.D., discovered Muse cells as a naturally occurring, stress enduring cell population. Dezawa MuseCell biology and investigational applications have since 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 product specifications addressing identity, purity, viability, potency, traceability and lot release. This common manufacturing and quality framework is intended to preserve defined DMC identity across qualified bone marrow, adipose and perinatal sources while allowing source-specific biological characteristics to be evaluated and controlled.
“Celularity brings the infrastructure and technical depth required to establish U.S. manufacturing across qualified bone marrow, adipose and perinatal sources,” said Dominik Duscher, M.D., Ph.D., Chief Executive Officer and President of MuseCell Innovations. “The central scientific and quality principle is that Dezawa MuseCell identity is defined by manufacture under the licensed Dezawa Method and conformance to MCI’s product specifications—not by the anatomical source alone. That distinction allows the platform to expand without abandoning the methodology and standards that define the DMC phenomenon.”
“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, Traceability and Manufacturing Control
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 preserving product-specific quality controls and the distinction between MCI-authenticated DMC products and unverified SSEA-3-positive preparations manufactured outside the licensed Dezawa Method and MCI’s release framework.
About Celularity
Celularity Inc. (Nasdaq: CELU) is a longevity-focused regenerative and cellular medicine company developing and manufacturing allogeneic and autologous cell therapies derived from the postpartum placenta. Celularity leverages the placenta’s unique biology, immunologic properties and scalable availability to develop therapeutic solutions targeting fundamental mechanisms of aging and age-related disease. Celularity’s cellular therapy portfolio includes cenplacel-L, its placental-derived allogeneic cell therapy, and other investigational cellular therapies. Celularity is headquartered in Florham Park, New Jersey, where it operates a purpose built facility supporting the development and manufacture of cellular therapies and advanced biomaterials.
For more information, please visit www.celularity.com.
About MuseCell Innovations
MuseCell Innovations® Pte. Ltd. (“MCI”), headquartered in Singapore, is the owner of the Dezawa MuseCell platform based on the discoveries of Professor Mari Dezawa, M.D., Ph.D. The platform encompasses Dezawa MuseCells, Dezawa MuseExosomes and Dezawa MuseSecretome and is defined by licensed manufacturing, MCI-controlled product specifications, lot-level testing and traceability. Muse cell biology and investigational applications have been described in more than 170 peer-reviewed publications and evaluated in multiple human clinical studies.
For more information, please visit www.musecellinnovations.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. federal securities laws, including statements regarding the collaboration between Celularity and MCI; the timing, execution and success of technology transfer, process development, manufacturing readiness activities, qualification, scale-up and product release; Celularity’s ability to establish manufacturing capability for DMCs from qualified bone marrow, adipose and perinatal sources; the ability of the licensed Dezawa Method and MCI product specifications to support reproducible manufacturing across source materials; the parties’ efforts to expand manufacturing to DMC-derived products; Celularity’s proprietary cellular medicine programs; and the parties’ plans and objectives in cellular medicine, regenerative medicine and longevity; and MCI’s estimate that its aggregate purchases from Celularity could exceed $300 million over the next five years.
Forward-looking statements are based on current expectations, estimates, assumptions and beliefs and are subject to risks and uncertainties that could cause actual results to differ materially. These risks include, among others, inability to complete technology transfer, qualify or validate a manufacturing process, achieve target yields, demonstrate comparability or release product; source-material and batch variability; unexpected technical or development challenges; safety, quality, regulatory, legal, intellectual-property, supply-chain, financing and commercial risks; changes in applicable laws or regulatory interpretations; and other risks described in Celularity’s filings with the U.S. Securities and Exchange Commission. The estimated value of potential purchases and statements regarding potential employment opportunities are based on current market conditions and assumptions regarding future demand, production requirements, product mix, pricing, successful manufacturing qualification, the scope and timing of any expansion of the collaboration, anticipated production volumes, staffing requirements and the parties’ continued collaboration. These statements do not constitute binding purchase or employment commitments, and there can be no assurance that MCI will make purchases in the amounts or within the time periods anticipated, or at all beyond its existing contractual commitments, or that any particular number of employment opportunities will be created, supported or retained, within any anticipated timeframe or at all. Neither cenplacel-L nor any MCI product described in this release has been approved or licensed by the U.S. Food and Drug Administration for any indication or use. Except as required by law, Celularity undertakes no obligation to update or revise any forward-looking statement.
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