MilliporeSigma

mRNA CDMO Services

Operator pushing mRNA drug substance bag into freezing trays

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.

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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.

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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.


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.

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High Performance

Through reduced product related impurities and increased mRNA homogeneity, resulting in higher stability and prolonged expression.

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Fully Synthetic mRNA Template

Ensuring high quality from the start of the process. IVT template generated in house.

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Increased Purity

Via cell free process, thereby mitigating microbial DNA, protein and endotoxin contaminants.

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Robust Scalable Process

Leading to reliable mRNA supply. From mg to multi-gram scale.

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Debottleneck pDNA Sourcing

10,000 fold less pDNA compared to conventional linearization approach. pDNA only needed according to GMP principles.

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Sequence Customization

Including flexible poly(A) tailing later during IVT template generation, circumventing truncation and pDNA yield limitations when pre-encoded.


TECHNICAL RESOURCES





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