Made Scientific, a leading Princeton-based clinical- and commercial-stage cell therapy contract development and manufacturing organization (CDMO), and Cellergy Therapeutics, a biotechnology company pioneering first-in-class mitochondrial transplantation therapies, announced a manufacturing partnership to advance Cellergy’s mitochondrial therapy, CLG-001, toward clinical trials.
With this collaboration, Cellergy will leverage Made Scientific’s GMP manufacturing capabilities to implement and scale Cellergy’s proprietary mitochondrial isolation and purification process. The work will support the production of clinical-grade CLG-001 for upcoming trials under Israel’s Ministry of Health (MoH) compassionate-use framework and a Phase I clinical study with the U.S. Food and Drug Administration (FDA).
CLG-001 is based on mitochondria purified from healthy donors and developed to restore cellular energy production — a novel therapeutic approach for conditions driven by mitochondrial dysfunction. These include metabolic disorders, neurodegenerative diseases and age-related conditions.
The partnership is designed to ensure a robust and compliant manufacturing pathway as Cellergy advances its innovative therapeutic platform from research to clinical translation.
“Our manufacturing partnership with Cellergy Therapeutics represents an exciting expansion of cell therapy into the emerging field of mitochondrial medicine — an important and promising new frontier for treating disease,” said Syed T. Husain, chairman and CEO of Made Scientific. “Made’s integrated development and cGMP manufacturing capabilities — including manufacturing in full compliance with U.S. FDA and EU GMP Annex 1 requirements, including Qualified Person (QP) release of drug product — are uniquely positioned to support the scale-up of this innovative therapy and to help ensure its clinical and commercial viability.
“We look forward to partnering with Cellergy to bring a transformative solution to patients affected by degenerative and metabolic diseases. Through this partnership, Made Scientific continues to build on its mission: Defy Limits. Deliver Results.”
