mRNA CDMO Services
mRNA Drug Substance Manufacturing Services
As part of our globally-integrated CTDMO capabilities, our mRNA Center of Excellence expedites your drug development journey, providing services including mRNA process development, mRNA analytical development, mRNA synthesis to purification of the final mRNA drug substance.
We provide flexible capacity for your needs - whether you tech transfer your process, or leverage our proprietary PCR-based, scalable, GMP mRNA process platform for achieving high product yields and exceptional quality for your individual mRNA sequence.
Through our GMP mRNA manufacturing expertise we ensure smooth process scale up from preclinical to commercial mRNA programs, as the single source provider of mRNA drug substance from milligram to double-digit gram scale, for all stages.
Our Track Record
15+
Years experience in mRNA drug substance manufacturing
2023
Launch of 2 harmonized GMP mRNA manufacturing facilities, covering all scales from preclinical to commercial
10,000
Fold less pDNA required through next generation PCR-based mRNA manufacturing
Streamlining mRNA-Sourcing with Our Single Source Service from Preclinical to Commercial
Our custom mRNA synthesis service delivers high quality mRNA for all stages of your mRNA program’s development journey. We provide flexible research grade mRNA packages from mg to g quantities, to double digit gram GMP mRNA drug substance batches supporting first in human studies to late clinical and commercial applications.
Propel your next project, by leveraging our more than 15 years’ experience and expertise in pre-clinical mRNA manufacturing.
- We develop, optimize and manufacture your sequences including:
- Choice of CleanCap® technology capping, Enzymatic Vaccinia capping, or ARCA capping
- Use of modified nucleotides
- Customizable poly(A) tail length
- Use of your own UTRs, or supply of our proven & tested UTRs
- Expedite your journey, through our simplified research grade mRNA packages
- Flexible manufacturing, purification and analytical packages at your service
- Milligram to gram scale batch capacity available
Let us assist you in designing your research-grade mRNA. Share your technical specifications, and one of our experts will review them and provide you with a quote.
Lay the foundation for success as your lead compound transitions to the pivotal first-in-human studies. Whether you tech transfer your process or leverage our proprietary PCR-based GMP mRNA production platform, we achieve high product yield and quality.
- Simplify GMP mRNA manufacturing through our in-house process & analytical development expertise
- Expedite your journey through an adaptable platform and templated approaches to manufacturing & analytical development
- Benefit from our quality and regulatory expertise for your program regulatory submissions
- Milligram to multi-gram batch capacity covering your early clinical mRNA demands
Experience seamless supply security through our late clinical to commercial manufacturing capabilities.
- Enable Phase III clinical trials and commercial supply through our PPQ capabilities
- Flexible capacity from small to large GMP batches for repeat manufacturing
- Ensure continuous commercial supply with our large scale GMP lines with up to 50 gram batches
Partner with us to bring transformative therapies to patients:
- Single source provider: GMP compliant* mRNA production in small to large scale quantities for all clinical and commercial phases.
- State-of-the-art process development: With more than 15 years of experience, we tailor our scalable and qualified platform process to your specific mRNA sequence.
- Fully compliant inspected GMP manufacturing*: De-risk your program by having quality and compliance ensured from the beginning, by manufacturing your mRNA in a facility holding a GMP certificate by local health authorities.
- Extensive Analytical Capabilities: Enabling success through our in-house analytical development & validation teams.
- Dedicated Project Management: Ensuring that projects are completed on time, within budget, and to the highest possible standards.
*mRNA as active substance for human use requires a GMP manufacturing authorization issued by the National Competent Authority
Key Features of PCR-based mRNA Manufacturing
With our proven PCR-based workflow, mRNA manufacturing is highly reproducible, leading to high quality and mRNA performance.
Through reduced product related impurities and increased mRNA homogeneity, resulting in higher stability and prolonged expression.
Ensuring high quality from the start of the process. IVT template generated in house.
Via cell free process, thereby mitigating microbial DNA, protein and endotoxin contaminants.
Leading to reliable mRNA supply. From mg to multi-gram scale.
10,000 fold less pDNA compared to conventional linearization approach. pDNA only needed according to GMP principles.
Including flexible poly(A) tailing later during IVT template generation, circumventing truncation and pDNA yield limitations when pre-encoded.
TECHNICAL RESOURCES
- Manufacturing Strategies for mRNA Vaccines and Therapeutics
Discover considerations for mRNA manufacturing and how mRNA is made. Learn how to purify and formulate mRNA and what to consider when scaling up the mRNA manufacturing process.
- Enabling Capabilities and Solutions for all mRNA platforms
Conquer the mRNA era with our integrated offering of products, a wide range of services, CDMO capabilities, regulatory and technical expertise.
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