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Manufacturer's authorization for cGMP mRNA

Written by Biospring | November 5, 2024

Frankfurt. BioSpring, a global leader in manufacturing and analyzing nucleic acids for therapeutics and diagnostics, is now also offering cGMP mRNA. The Frankfurt-based company received the manufacturer's authorization by the Hessian State Office for Health and Care. With this authorization, BioSpring is producing another class of active ingredients for the medicine of the future.

"With the production of cGMP mRNA, we are taking another step to expand our globally leading position in the production of therapeutic RNA for genome editing applications," says Dr. Sylvia Wojczewski, CEO of BioSpring. "We are building on 27 years of experience and expertise in the production and analysis of nucleic acids for therapeutics applications and diagnostics."

With the new capacities for cGMP mRNA, BioSpring offers their clients therapeutic mRNA of the highest quality across the entire development chain: from early research and development to preclinical studies and clinical trials (Phase I to III), all the way to commercial use. The complete package includes comprehensive analytical services, testing, and regulatory support.

Both mRNA and guide RNA from BioSpring are used for therapeutic genome editing applications. Genome editing enables the targeted modification of genes, presenting the opportunity for the development of entirely new and highly effective therapies for genetically caused diseases. This could potentially lead to the complete cure of diseases, where until now only the symptoms could be treated. In some cases, a single treatment could be enough, eliminating the need for long-term, often lifelong medication.

 

New production facility

BioSpring has significantly expanded its capacities for the new cGMP production of guide RNA and mRNA. With an investment in the double-digit millions, the company has built new production facilities in Frankfurt. In the coming years, BioSpring plans further capacity expansion with new production plants and laboratories in Offenbach am Main. Already today, BioSpring possesses the world's largest cGMP RNA production capacities for genome editing programs.

With the cGMP manufacturing license for mRNA BioSpring has reached another milestone and further strengthens its globally leading position in manufacturing and analyzing therapeutic nucleic acids.