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Manufacturing Services

Messenger RNA (mRNA)

Moving the elements of life

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 mRNA Works

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.

Moving the elements of life

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)
  • Adapting to your needs: Process development, scale-up, and tech transfer
  • >18 years of experience in clinical and commercial manufacturing of RNA, including four 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 (HR-MS) for capping and poly(A) tail integrity, and ELISA for dsRNA detection
  • Single assay for capping efficiency and poly(A) tail length by HR-MS
  • 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) 
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Your Success Begins with us

Why Choose BioSpring?

Project Management and Regulatory Support

With your success as our priority, our dedicated project managers and subject matter experts provide strategic and technical support from your initial inquiry to product delivery and beyond. Our regulatory team offers comprehensive support, handling everything from technical writing and dossier maintenance to thorough reviews of submissions like IND, NDA, BLA, and DMF filings, ensuring all documentation meets regulatory standards. 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 and our regulatory support.

Your success begins with us

Why Choose BioSpring?

State-of-the-Art Facilities

Our FDA-inspected facilities are designed to optimize capacity utilization and ensure rapid turnaround with high-throughput capabilities, allowing us to support versatile batch requirements for programs targeting both ultrarare and more prevalent diseases. Equipped to manage every aspect of nucleic acid manufacturing and analysis—from small-scale preclinical batches to commercial-scale production—BioSpring brings nearly three decades of experience to ensure your nucleic acid programs are delivered on time and meet the highest quality standards.

Learn more about our facilities.

Your success begins with us

Why Choose BioSpring?

Comprehensive Services

At BioSpring, we provide a full suite of manufacturing and analytical 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.

Learn more on our manufacturing and analytical services.

Your success begins with us

Why Choose BioSpring?

Decades of Expertise

With almost 30 years of experience in oligonucleotide process chemistry, we have been at the forefront of nucleic acid technology, advancing the limits in nucleic acid manufacturing and analysis. Since achieving cGMP certification in 2007, we have continuously upheld the highest standards in quality and compliance. Our commitment to excellence and almost a decade of commercial experience helps you harness the full therapeutic potential of nucleic acid-based therapies​​.

Learn more about our history.

Your success begins with us

Why Choose BioSpring?

Flexible Timelines

We understand that timing is everything in drug development. That’s why our services are designed with flexibility in mind. From clinical trials to commercial production, we work closely with you to meet your goals efficiently and on schedule. No matter where you are in your development cycle, we ensure that our services align with your unique timeline​.

Learn more about our solutions

Keep Exploring

Learn more about the nucleic acids we can manufacture for you:

ASOs, CpG ODNs, guide RNAs, siRNAs, & more

Learn more about the manufacturing grades we offer for your nucleic acids: 

cGMP - Commercial / Clinical, Pre-GMP, Preclinical,
Research, Diagnostics