A new era of medicine IVT mRNA manufacturing

High-Quality Solutions for your Therapeutic Genome Editing Needs

cGMP IVT mRNA Manufacturing

What is mRNA?

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.

How is mRNA used?

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

Preclinical mRNA Manufacturing

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)

cGMP-Grade mRNA Manufacturing

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

mRNA Capabilities

Ensuring Accuracy and Integrity

Analytical Services for mRNA

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:

High-resolution analysis: Single analysis, high-resolution mass spectrometry (MS) for capping and poly(A) tail integrity, and ELISA for dsRNA detection
Single assay for capping efficiency and poly(A) tail length by HRMS
High-fidelity in-house sequencing using NGS
dsRNA measurements with superior sensitivity
Various ribonucleic acid quantification methods available
Method validation, characterization, release testing, and stability studies

Excerpt of R&D-grade release testing scope:

Integrity by CE
Purity
Impurities
UV absorbance
mRNA concentration
Endotoxin (optional)

Why choose BioSpring? Comprehensive Services At Every Stage

At BioSpring, we provide the full suite of services to support your project from start to finish. Whether you’re in the early phases of your therapeutic nucleic acid program or looking to scale up production, we’ve got you covered. Our expertise ensures seamless transitions through each stage, so your project progresses smoothly, from initial concept to the commercial market.

Why choose BioSpring? Decades of Expertise Since 1997

Our robust and scalable manufacturing processes are backed by over two decades in RNA process chemistry. We are fully committed to helping our clients harness the full therapeutic potential of their genome editing platform.

Why choose BioSpring? Flexible Timelines Ready when you are

We understand that timing is everything in drug development, that’s why our process is designed with flexibility in mind. We work closely with our clients to meet their goals efficiently and on schedule. No matter where our clients are in their development cycle, we ensure that our services align with their unique timeline.

Why choose BioSpring? Client-Centric Services Project Management

With your success as our priority, our dedicated project managers provide strategic support from your initial inquiry to product delivery and beyond. Count on us to be by your side throughout the entire project lifecycle, ensuring your goals are achieved every step of the way.

Learn more about our project management.

Why choose BioSpring? State-Of-The-Art Facilities Driving Success

Leveraging BioSpring's extensive experience in cGMP manufacturing and regulatory processes, our state-of-the-art facilities in Germany are equipped to handle every aspect of mRNA manufacturing and analysis, from small-scale preclinical batches to commercial-scale production.

Realize the full potential of your genome editing programm!

Download our mRNA factsheet now and discover how BioSpring's advanced solutions can take your project to clinical sucess.

Download our mRNA flyer

The nucleic acid company

About BioSpring

BioSpring is a leading industry expert in nucleic acid science and technology, specializing in high-quality cGMP manufacturing and analytics for commercial programs and clinical phases I - III, in addition to preclinical material supply and diagnostic manufacturing. We are a privately owned company of over 650 employees committed to providing expert support through all phases and regulatory filings, including highly flexible and customizable solutions to accelerate therapeutic programs through the entire drug development lifecycle.

Headquartered in the center of Europe, in Frankfurt, Germany, we are an international company with a subsidiary in the United States and a local presence in Japan. Our global clients can rely on our quality and expertise, guided by our passion for innovation and three decades of experience. Our aim is a highly collaborative partnership to unleash the full potential of our clients’ technology, making great strides and breakthroughs possible.

650 Employees

40 Nations