- Made Scientific, Inc. and Cellergy Therapeutics have formed a manufacturing partnership to advance the mitochondrial therapy CLG-001 toward first-in-human studies.
- The collaboration will use Made Scientific’s GMP capabilities to support clinical-grade production for compassionate-use programmes and an FDA Phase I trial.
Made Scientific, Inc. and Cellergy Therapeutics Ltd. have entered a manufacturing partnership to support the advancement of Cellergy’s mitochondrial therapy CLG-001. The agreement aims to prepare the treatment for first-in-human clinical studies. CLG-001 will be manufactured for clinical use under Israel’s Ministry of Health compassionate-use framework and for a Phase I clinical trial with the U.S. Food and Drug Administration.
Under the collaboration, Cellergy will use Made Scientific’s GMP manufacturing capabilities to implement and scale its mitochondrial isolation and purification process. The work is intended to ensure a compliant and reliable manufacturing pathway as the therapy progresses from research into clinical development.
CLG-001 is developed from mitochondria purified from healthy donors. The therapy is designed to restore cellular energy production and targets conditions associated with mitochondrial dysfunction, including metabolic disorders, neurodegenerative diseases and age-related conditions.
Made Scientific noted that the partnership extends cell therapy manufacturing into the emerging field of mitochondrial medicine.
“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.”
Syed T. Husain, Chairman and CEO of Made Scientific
Cellergy highlighted the technical expertise provided by the CDMO. Rachel Diamant, CEO of Cellergy Therapeutics, said that Made Scientific offers proven capabilities needed to move CLG-001 into clinical evaluation. The companies stated that the collaboration brings together Cellergy’s work in mitochondrial science with Made Scientific’s manufacturing capabilities to accelerate clinical translation.
