Made Scientific, Inc., a U.S.-based clinical and commercial-stage cell therapy contract development and manufacturing organization (CDMO), has announced a new manufacturing partnership with Cellergy Therapeutics Ltd., a biotechnology company developing first-in-class mitochondrial transplantation therapies. The collaboration aims to advance Cellergy’s lead therapeutic candidate, CLG-001, into first-in-human clinical studies, marking a significant milestone for the emerging field of mitochondrial medicine.
Under the agreement, Cellergy will leverage Made Scientific’s GMP-compliant manufacturing expertise to scale and implement its proprietary mitochondrial isolation and purification processes. These capabilities will enable the production of clinical-grade CLG-001 for both compassionate-use programs authorized by Israel’s Ministry of Health (MoH) and an upcoming Phase I clinical trial with the U.S. Food and Drug Administration (FDA). The partnership underscores the growing interest in mitochondrial-based therapies, which are designed to address cellular energy deficits at their biological root.
CLG-001 is developed using mitochondria purified from healthy donors. The candidate therapy is designed to restore cellular energy production—an approach that opens new possibilities for treating a range of conditions linked to mitochondrial dysfunction, including metabolic disorders, neurodegenerative diseases, and age-related health decline. By transferring functional mitochondria into damaged or energy-deficient cells, the therapy aims to correct underlying bioenergetic failures that drive disease progression.
Ensuring a reliable and compliant manufacturing pathway is critical for Cellergy as it prepares for clinical translation. Made Scientific, known for its integrated development services and adherence to rigorous regulatory standards, will provide end-to-end support. The company manufactures therapies under full U.S. FDA and EU GMP Annex 1 compliance, including Qualified Person (QP) release—an essential requirement for therapies intended for clinical use in global jurisdictions.
Syed T. Husain, Chairman and CEO of Made Scientific, highlighted the significance of the collaboration. “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,” he said. He emphasized that Made Scientific’s development capabilities and cGMP infrastructure are well suited to support the scale-up of a novel therapy like CLG-001. “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.”
Cellergy’s CEO, Rachel Diamant, echoed the sentiment, noting that Made Scientific’s technical expertise and track record make it an ideal manufacturing partner. “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,” she said.
The collaboration brings together Cellergy’s scientific leadership in mitochondrial biology and Made Scientific’s strengths in advanced therapy manufacturing. As CLG-001 progresses toward clinical evaluation, the partnership is expected to accelerate the development of a first-in-class therapeutic approach aimed at restoring cellular energy—and potentially transforming treatment options for patients with limited therapeutic alternatives.