Princeton-based Made Scientific a prominent U.S.-based cell therapy contract development and manufacturing organization (CDMO), and Cellergy Therapeutics Ltd., a biotechnology company focused on mitochondrial transplantation therapies, on Monday announced a strategic manufacturing partnership.
The collaboration is designed to advance Cellergy’s innovative mitochondrial therapy, CLG-001, toward its first-in-human clinical studies in both the U.S. and Israel.
CLG-001 represents a novel therapeutic strategy, utilizing mitochondria purified from healthy donors to restore cellular energy production in patients. This approach targets conditions driven by mitochondrial dysfunction, including metabolic disorders, neurodegenerative diseases, and age-related conditions.
Under the agreement, Cellergy will leverage Made Scientific’s Good Manufacturing Practice (GMP) capabilities to scale and implement its proprietary mitochondrial isolation and purification process.
The manufacturing effort will support the production of clinical-grade CLG-001 for two key pathways:
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Compassionate Use: Upcoming trials under Israel’s Ministry of Health (MoH) compassionate-use framework.
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Phase I Study: A planned Phase I clinical study with the U.S. Food and Drug Administration (FDA).
Syed Husain, chairman and CEO of Made Scientific, emphasized the significance of the partnership, stating it represents an “exciting expansion of cell therapy into the emerging field of mitochondrial medicine.” He added that Made Scientific’s integrated cGMP manufacturing capabilities are “uniquely positioned” to support the scale-up of this innovative therapy and ensure its clinical and commercial viability.
Rachel Diamant, CEO of Cellergy Therapeutics, noted that Made Scientific’s “deep technical expertise and proven capabilities” make them an ideal partner as CLG-001 moves toward the clinic. “Together, we aim to redefine how cellular energy deficits are addressed,” she stated.
The partnership combines Cellergy’s leadership in mitochondrial science with Made Scientific’s manufacturing excellence, providing a robust and compliant pathway to accelerate the translation of CLG-001 from research into clinical development.
