cGMP IVT mRNA Manufacturing
Messenger RNA (mRNA) is a carrier molecule that moves information encoded for a protein from a chromosome within a nucleus to the translation site in the cytoplasm. mRNA’s capacity to employ a cell’s translational machinery positions it as a universal blueprint for protein production, dictating the production of proteins that are essential for various biological functions.
Since the mRNA vaccine race to market with the advent of COVID-19, a new generation of mRNA therapeutics has sparked interest in the biotechnology world. Its rapid development and adaptability make mRNA a powerful tool in addressing a wide range of health conditions.
mRNA can be synthesized to instruct cells to produce specific proteins, which can be used to treat or prevent diseases. This approach offers a flexible platform for addressing a wide range of medical conditions and for the development of novel therapies. mRNA technology allows for the development of targeted treatments for genetic disorders, the creation of cancer vaccines, and the enhancement of the body's immune response to infections. In gene editing, mRNA can be engineered to encode specific proteins, such as Cas9, which, when used alongside guide RNA, facilitates precise and targeted modifications to the genome.
mRNA Services Overview
BioSpring offers end-to-end services for custom in vitro transcription (IVT) mRNA production, offering comprehensive and integrated services for mRNA manufacturing, upscaling, and analytics. Our mRNA manufacturing solutions are designed to meet the highest quality standards to support early discovery and preclinical programs through clinical and commercial programs.
- Your partner for all stages: research-grade through cGMP manufacturing (ICH Q7)
- cGMP mRNA batch sizes up to 250 mg
- Adapting to your needs: Process development, scale-up, and tech transfer
- >17 years of experience in clinical and commercial manufacturing of RNA, including 3 commercial products
- Highly experienced in large-scale downstream processing for cGMP programs involving HPLC purification
- Synthesis and purification of research- and preclinical-grade mRNA, starting at µg batch sizes
- Fully customizable options for capping, poly(A) tail length, and modifications
- Highly pure mRNA through cutting-edge HPLC technology
- Manufacturing timelines of approximately 14 days (from receipt of DNA template)
- State-of-the-art facilities with ISO-classified cleanrooms
- Flexible batch sizes up to 250 g and fully customizable options for capping, poly(A) tail length, and modifications
- Powerful platform for flexible process development
- Highly pure mRNA through cutting-edge HPLC technology
- Regulatory support
Our Capabilities
Your program benefits of our customizable analytical solutions ensuring the highest quality and stability of your mRNA products. We offer an extensive suite of services, including: Excerpt of R&D-grade release testing scope: Analytical Services for mRNA
Experience the BioSpring Advantage
Partner with BioSpring and benefit from our commitment to quality, innovation, and excellence in RNA
manufacturing and analytical technology. BioSpring is one source for your gene editing needs.