mRNA Manufacturing and Formulation

Unleashing the power of mRNA technology to revolutionize how diseases are treated and prevented relies on robust and consistent processes . Our lipid nanoparticle (LNP) manufacturing processes ensure a high-quality and consistent supply. Our portfolio and services, including our lipids and LNP CDMO services and mRNA testing services, address the most critical challenges in mRNA-based therapeutics manufacturing enabling fast timelines and high-quality purified drug products.

We also realize that protecting mRNA from degradation risks by RNases or microbial contamination is key to successful mRNA manufacturing, purification, and formulation. That’s why we offer our high-quality pharma raw materials that are tested for endonuclease activity and have low bioburden and endotoxin levels. Our pharma/biopharma raw materials also comply with IPEC-PQG GMP requirements and are part of the Emprove^®Program. The program offers comprehensive regulatory documentation and covers also some of our filters and single-use components and selected chromatography resins.

Plasmid DNA Production, mRNA Synthesis, and mRNA Purification Products

Our products can be used for the entire mRNA synthesis workflow from generating plasmid DNA to synthesizing mRNA and finally to purifying mRNA. They come in a variety of sizes so that you can scale up from development to suit your production goals. These include:

• High-quality raw materials and excipients including endonuclease-free chemicals, in vitro transcription (IVT) enzymes and nucleoside triphosphates (NTPs) backed by regulatory support as part of the Emprove^® Program
• Fluid management systems throughout production including single-use assemblies, single-use mixers (ex: 10L and 50L), sterile sampling systems, and connections/disconnections for bioprocessing
• Sterile filters for bacterial removal throughout the process
• Clarification depth filters and clarification filter holders and systems to efficiently remove cells, cellular debris, and other insoluble contaminants and impurities
• Tangential flow filtration (TFF) and chromatography systems and consumables to remove restriction enzymes, BSA, DNA fragments, endotoxins, and other impurities. We offer several options for anion exchange chromatography that can be easily scaled from the lab bench. TFF can also be used to exchange buffers during plasmid linearization, in vitro transcription, and more.

These materials can also be used during the mRNA formulation steps.