Scaling up mRNA rapidly and reliably for use as vaccines and therapeutics is an important step in moving a drug from novel concept to clinical trials. Given the flexibility of mRNA as a platform technology, mRNA is an ideal technology for responding to fast-moving diseases.
We're here to help you through the entire development phase whether it be mRNA testing, regulatory, or clinical trial materials so that you can lay down the best foundations for your process as you move towards manufacturing. We can help you choose the right materials at the development phase that meet compliance needs for your application to ensure your process is viable in terms of feasibility and scalability. Spanning from non-GMP to IPEC GMP-grade process chemicals, many of our pharma and biopharma materials are part of the Emprove® Program and have all the documentation that you’ll need to go through qualification, risk assessment, and process optimization. The Emprove® Program also covers filter and single-use components as well as select chromatography resins.
mRNA characterization is a necessary component of method development. We provide a wide range of products and services that meet your compliance standards for characterizing mRNA in biopharmaceutical applications, including:
pDNA production and purification present several challenges due to the large size of the nucleic acid and its high viscosity, shear sensitivity and the similarities between the product and impurities. Additionally, scaling up mRNA synthesis and purification for the delivery of mRNA vaccines and in other biopharmaceutical applications requires purification products and tools that give consistent batch-to batch results. Our comprehensive portfolio of products and services for plasmid DNA production through mRNA synthesis and purification help you navigate through these challenges and can be used from the development phase through manufacturing allowing for easy scale-up of your process.
As part of our integrated mRNA CDMO, we support mRNA development and manufacturing from milligram to gram scale using the AmpTec™ workflow. This covers all steps from pDNA to the final purified mRNA drug substance. Our portfolio and services address the most critical challenges in mRNA manufacturing enabling fast timelines and high-quality purified drug products. Learn more about our custom mRNA CDMO services here.
We provide a variety of lipids to design the most appropriate lipid nanoparticle formulation and deliver your mRNA efficiently. Aside from lipids, we supply a variety of pharma raw materials including IPEC GMP compliant Emprove® Chemicals like solvents, buffers, salts, and stabilizers for liquid formulations.
To ensure that drug and mRNA therapies are safe for patients, preclinical safety screening requires scalable products with exceptional reproducibility. We offer a reliable portfolio of assays and products, including:
In addition to high-quality products, our experts provide a variety of reliable services to help researchers in the biopharmaceutical sector develop new drugs and therapeutics. Our support and services include:
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