
mRNA Drug Product Manufacturing
Achieve Breakthroughs in mRNA Technology with Comprehensive Services
Are you struggling with the intricacies of mRNA technology, from DNA plasmid templates to mRNA drug substance and drug product manufacturing? Do you face challenges in scaling production, meeting regulatory requirements, and accelerating your time to market? Our team of highly skilled scientists possesses extensive expertise in mRNA technology, and we are committed to assisting you throughout your journey. Our comprehensive support is designed to expedite your discoveries, streamline production scaling, navigate regulatory hurdles, and ultimately accelerate your time to market.
- Plasmid DNA template manufacturing – Integrate high-quality plasmid DNA template production and linearization into your phase-appropriate mRNA manufacturing process
- mRNA drug substance production – Leverage our custom mRNA synthesis with HiCap® RNA polymerase for high quality, reduced impurities, and increased capping efficiency
- Drug product LNP encapsulation to fill/finish– Final mRNA drug product manufacturing for compliant and efficient LNP delivery through multiple mixing methods, scales, and phase-appropriate quality grades
- cGMP manufacturing– Streamline late-phase clinical mRNA drug substance and product manufacturing with our analytical and regulatory support
Our mRNA services provide scalability, raw material and process controls, raw material cost control and RG-to-cGMP transferability, ensuring consistent quality and affordability.
We provide essential support through our experience in plasmid linear DNA templates and drug substance manufacturing to produce high-quality mRNA. With extensive technical expertise in fermentation, biocatalysis, in vitro transcription, purification techniques, and a large variety of in-house analytical methods for product characterization and stability studies, we bring you the confidence to achieve your goals in the mRNA landscape.
Contact us today to get started!
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