BioSpring GmbH. (11/5/24). "Press Release: BioSpring Has Been Granted Manufacturing Authorization (ICH Q7) for cGMP-grade mRNA Production from the German Authorities". Frankfurt a. M..

	Region	Frankfurt am Main
	Country	Germany
	Organisation	BioSpring Gesellschaft für Biotechnologie mbH (BioSpring GmbH)
	Group	BioSpring (Group)
	Organisation 2	Hessen (Hesse) (govt region)
	Product	mRNA technology
	Product 2	oligo synthesis
	Person	Wojczewski, Sylvia (BioSpring GmbH 201205 Managing Director + Co-Founder)
	Person 2	Schink, Martin (BioSpring 202212 Senior Team Lead Marketing)

After 17 years of successfully producing cGMP oligonucleotides for clinical and commercial applications, we are thrilled to announce the addition of cGMP mRNA to our offerings. Read more

Manufacturer's authorization for cGMP mRNA: BioSpring and the medicine of tomorrow

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.

Contact

Dr. Martin Schink, Senior Team Lead Marketing & Communcations
BioSpring Gesellschaft für Biotechnologie mbH
Alt-Fechenheim 34, 60386 Frankfurt am Main
Telefon: +49 (0) 69 66055000
E-Mail: [email protected]

About BioSpring

BioSpring is a contract manufacturer for the biotech and pharmaceutical industries and a global leader in the production and analysis of nucleic acids, which are used in medicine, diagnostics, bioanalytics and research. Nucleic acids are made up of the same building blocks as human genetic material. BioSpring is the world's leading manufacturer of therapeutic genome editing components (genome editing) used in cell and gene therapy. The active ingredients produced at BioSpring have the potential to enable therapies for a plethora of untreatable diseases. These include novel compounds for the treatment of cardiovascular, neurological, and metabolic diseases (and more), as well as cancer.

BioSpring was founded in Frankfurt am Main by Dr. Hüseyin Aygün and Dr. Sylvia Wojczewski. The company, which now has over 650 employees, has its production headquarters in Frankfurt-Fechenheim, Germany, as well as a subsidiary in San Diego, USA, and, in the future, an additional 170,000 ft2 production facility in Offenbach am Main, Germany, where up to 1,500 jobs will be created in the long term.

Record changed: 2024-11-25