Made Scientific and Cellergy Therapeutics Form Partnership to Advance Mitochondrial Therapy

Made Scientific, Inc., a prominent U.S.-based clinical- and commercial-stage cell therapy contract development and manufacturing organization (CDMO), has teamed up with Cellergy Therapeutics Ltd., an innovative biotechnology company specializing in mitochondrial transplantation therapies. This partnership is set to advance Cellergy's mitochondrial therapy, CLG-001, toward first-in-human clinical studies.

Under the collaboration, Cellergy Therapeutics will utilize Made Scientific's GMP manufacturing capabilities to implement and scale its proprietary mitochondrial isolation and purification process. The initiative will facilitate the production of clinical-grade CLG-001 for forthcoming 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 derived from mitochondria purified from healthy donors, aimed at restoring cellular energy production—a unique therapeutic strategy for conditions associated with mitochondrial dysfunction, such as metabolic disorders, neurodegenerative diseases, and age-related conditions. The partnership is structured to establish a robust and compliant manufacturing pathway, supporting Cellergy's innovative therapeutic platform as it transitions from research to clinical application.

"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," stated Syed T. Husain, Chairman and CEO of Made Scientific. He added, "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."

Rachel Diamant, CEO of Cellergy Therapeutics, remarked, "Made Scientific brings deep technical expertise and proven capabilities in cell therapy manufacturing, making them an ideal partner as we advance CLG-001 toward the clinic. Together, we aim to redefine how cellular energy deficits are addressed, with the goal of restoring health and function for patients affected by mitochondrial dysfunction related conditions." This collaboration combines Cellergy's leadership in mitochondrial science with Made Scientific's manufacturing excellence, accelerating the progression of CLG-001 into clinical development.