We see a way to accelerate your GMP mRNA drug product manufacturing timeline by 50%
mRNA Development, Manufacturing and Production
WHY IT MATTERS
Why Efficient mRNA Characterization Matters
RNA therapies continue to challenge the central tenets of how we treat diseases; however, mRNA development and characterization are not always simple.
Due to its instability, mRNA necessitates rigorous analytical validation at every processing step. Proper quality controls can ensure consistent synthesis and packaging into lipid nanoparticles, resulting in better therapeutic outcomes.
Leverage a partner with an extensive portfolio and accelerate mRNA development and manufacturing
Our Danaher Life Sciences companies support mRNA development, characterization and manufacturing processes with its comprehensive platform of best-in-class science and technology companies. We recognize the necessity for life cycle management and aim to address this with our extensive instrument, software and services portfolio.
CUSTOMER SUCCESS STORY
Customer Success Story: Customized Data Workflows
Highly configurable application-specific data workflows
Due to the variety of structures and modalities of our drug candidates, an in-depth characterization of our drug candidates simply cannot be achieved using a “one-size-fits-all” data processing solution.
FAQs
mRNA is a single-stranded molecule composed of nucleotides (adenine, guanine, cytosine, uracil) linked by phosphodiester bonds. It complements one DNA strand, differing only in the presence of uracil instead of thymine. Each nucleotide contains a nitrogenous base and ribose sugar.
Mature mRNA is made up of distinct segments: 5′ cap, 5′ UTR, coding region, 3′ UTR and poly(A) tail. The coding region starts with 'AUG' and ends with stop codons. UTRs are located before and after the coding region, influencing gene expression, RNA stability, translation efficiency and mRNA localization. The 5′ cap is at the mRNA's 5′-end, while the Poly(A) Tail is at the 3′-end.
mRNA is versatile and can be used to express and research therapeutic or defective proteins. mRNA has high transfection efficiency and low toxicity and doesn't require nuclear entry. Certain mRNA-based therapeutics can continuously translate into proteins, ensuring prolonged expression. These features make mRNA a promising technology in biomedical fields, offering potential benefits for patients with incurable diseases.
A primary obstacle in mRNA technology is the need to enhance stability and delivery systems, given the inherent instability and susceptibility to degradation of mRNA molecules. Moreover, achieving effective, targeted and safe in vivo delivery of mRNA continues to be a major hurdle that necessitates further advancements.
Proper planning is crucial for ensuring and managing scalability. Rigorous quality assurance is necessary to advance large-scale cell manufacturing without compromising therapeutic effectiveness. Automated and intelligent operations that maintain a robust data management program are required for scaling mRNA production and purification processes. Non-viral delivery systems like lipid nanoparticles (LNPs) are attractive options that scale.
mRNA shows great promise in therapeutics, allowing for rapid and scalable response to infectious and genetic diseases. Personalized medicine, especially in rare disease treatment, can greatly benefit from tailored treatment options. Despite challenges, breakthroughs in biotechnology, molecular medicine and nanotechnology are helping realize mRNA's full potential.