Moving the elements of life
Manufacturing Services
Messenger RNA (mRNA)
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)
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.
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 oligonucleotide and mRNA 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.
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 oligonucleotide/mRNA program or looking to scale up production, we’ve got you covered.
Learn more on our manufacturing and analytical services.
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 oligonucleotide- and mRNA-based therapies.
Learn more about our history.
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.
