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news.Made Scientific and Cellergy Therapeutics have formed a manufacturing partnership to advance the latter’s CLG-001 mitochondrial therapy toward first-in-human studies.
The partnership combines Cellergy’s expertise in mitochondrial science with Made Scientific’s manufacturing capabilities. Credit: Stock-Asso/Shutterstock.com.
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Cellergy will utilise the good manufacturing practices (GMP) expertise of Made Scientific to enhance its mitochondrial isolation and purification process for the clinical-grade production of CLG-001.
This work aims to facilitate a Phase I clinical trial with the US Food and Drug Administration (FDA) as well as forthcoming trials under the compassionate-use programme of Israel’s Ministry of Health.
CLG-001 utilises mitochondria purified from healthy donors to restore cellular energy production, targeting conditions caused by mitochondrial dysfunction including age-related conditions, metabolic disorders and neurodegenerative diseases.
The partnership seeks to establish a regulatory-compliant manufacturing pathway to transition Cellergy’s therapy from research to clinical application.
It combines Cellergy’s expertise in mitochondrial science with Made Scientific’s manufacturing capabilities to accelerate the clinical development of CLG-001.
Made Scientific chairman and CEO Syed Husain stated: “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.
“Made’s integrated development and current GMP manufacturing capabilities —i ncluding manufacturing in full compliance with US FDA and EU GMP [European Union good manufacturing practice] Annex 1 requirements including Qualified Person 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.”
Cellergy Therapeutics CEO Rachel Diamant stated: “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.”
