Miami, Florida — Cellgenic, the biologics manufacturing division of Global Stem Cells Group (GSCG), today announced that its advanced biologics manufacturing facility in Cancún, Mexico, has officially commenced full operations. Following its initial introduction to the international medical community during the ISSCA Global Regenerative Medicine Summit in September 2025, the laboratory is now actively producing and distributing biologic products to authorized medical professionals and institutions in international markets where local regulations permit.
The operational launch represents an important step in what Cellgenic hopes will be a long-term effort to support responsible access to regenerative biologics through transparent manufacturing processes, ethical sourcing, and internationally guided quality practices.
Purpose-Built Facility Designed for International Distribution
The Cancún laboratory was designed as a centralized manufacturing hub intended to support physicians, clinics, wellness centers, and research institutions seeking access to advanced biologics. The facility incorporates modular cleanroom environments, controlled cold-chain logistics, structured batch documentation, and donor traceability systems developed with reference to AATB-aligned practices and COFEPRIS-guided operational frameworks.
To Cellgenic’s knowledge, this facility is the first in Cancún developed specifically for the external manufacturing and distribution of biologics, rather than production limited to internal or single-site clinical use.
Xeno-Free Manufacturing Philosophy
All biologics produced at the Cancún facility are manufactured under xeno-free conditions, meaning that no animal-derived components are used at any stage of production. Cellgenic’s manufacturing philosophy emphasizes the use of human-origin materials, controlled inputs, and documented sourcing processes.
While Cellgenic does not make claims regarding clinical outcomes, the company believes that xeno-free manufacturing practices may support broader international acceptance and alignment with evolving regulatory expectations in multiple regions. The company hopes that this approach will offer physicians and institutions additional confidence when evaluating biologics for educational, investigational, or authorized clinical use.
Integration with Cellular Hope Institute and ISSCA
The facility operates in close coordination with the Cellular Hope Institute, a clinical and educational center operating under Global Stem Cells Group. based in Cancún, as well as with ISSCA (International Society for Stem Cell Application), the educational division of Global Stem Cells Group.
Through this integration, visiting physicians and researchers participating in ISSCA-accredited programs may observe manufacturing workflows, engage in hands-on educational sessions, and participate in structured clinical discussions related to biologics handling and responsible application.
“We expect this facility to play a meaningful role in our integrated model of manufacturing, education, and clinical collaboration,” said Sarah Barroso, Managing Director of Cellgenic. “By aligning our laboratory operations with the Cellular Hope Institute and ISSCA’s educational platform, we hope to contribute to greater transparency, consistency, and professional dialogue within the regenerative medicine field.”
Current Manufacturing Capabilities and Pipeline Development
As of January 2026, the Cancún facility is producing the following biologics for authorized distribution:
- Exosome Flow Series – Liquid exosomes available in multiple concentrations
- Lyophilized Exosomes – Prepared for topical and localized applications
- Umbilical Cord–Derived Mesenchymal Stem Cells (MSCs) – Cryopreserved and culture-expanded
- Natural Killer (NK) Cells – Produced under controlled freezing and handling protocols
- Allogeneic Fibroblasts – Intended for aesthetic and research-oriented applications
- Sterile Diluents – Including bacteriostatic water and saline solutions
Cellgenic has also outlined plans to expand its capabilities during 2026 to include:
- Exosome–peptide combination formulations
- Multi-peptide blended delivery formats
- Cell-free conditioned media (secretome)
- Cryopreserved cell banking services
- Private-label and white-label manufacturing programs
All products are accompanied by batch documentation, donor screening records, and handling guidelines. Cellgenic emphasizes that its biologics are not intended to diagnose, treat, cure, or prevent any disease and are supplied exclusively to authorized professionals and institutions in compliance with local regulations.
Commitment to Responsible Global Expansion
As part of its international growth strategy, Cellgenic has introduced an Authorized Distributor Program designed for qualified partners operating in compliant markets. The program is structured to support long-term collaboration through educational resources, standardized documentation, and regional alignment initiatives.
“We believe this facility reflects our continued focus on responsibility, quality, and long-term infrastructure,” said Dave Christensen, CEO of Global Stem Cells Group. “Our goal has never been rapid expansion without structure. We hope this laboratory will support physicians and institutions seeking consistent, well-documented biologics produced under carefully designed conditions.”
About Cellgenic
Cellgenic is the biologics manufacturing and innovation division of Global Stem Cells Group, a multinational organization engaged in regenerative medicine education, clinical collaboration, and biologics development. With operations and partnerships across North America, Latin America, Europe, and Asia, Cellgenic focuses on producing biologics under transparent, xeno-free, and compliance-oriented frameworks to support responsible use in diverse international settings.
Safe Harbor Statement: Statements in this news release may be “forward-looking statements”. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions, or any other information relating to our future activities or other future events or conditions, including those related to the operational launch and expansion of capabilities at our Cancún, Mexico biologics manufacturing facility. These statements are based on current expectations, estimates, and projections about our business based partly on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties, and assumptions that are difficult to predict. Therefore, actual outcomes and results may and are likely to differ materially from what is expressed or forecasted in forward-looking statements due to numerous factors. Any forward-looking statements speak only as of the date of this news release, and The Global Stem Cells Group undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date of this news release.
