mRNA Manufacturing and Formulation

Unleashing the power of mRNA technology to revolutionize how diseases are treated and prevented relies on robust and consistent processes to make the mRNA and then purify and formulate it. Our mRNA manufacturing template provides a robust workflow, while our lipid nanoparticle (LNP) manufacturing processes ensure a high-quality and consistent supply. Our portfolio and services, including our mRNA CDMO and testing services, address the most critical challenges in mRNA 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:

• Process and Formulation Chemicals with low bioburden and endotoxin levels, critical products tested for endonuclease activity and part of the Emprove^® Chemicals portfolio
• 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.

mRNA Contract Development and Manufacturing Services

Our integrated CDMO capabilities include the development and manufacture of custom mRNAs. With our proven AmpTec^™ workflow, mRNA manufacturing is highly reproducible. Key features include:

• Production of fully customizable sequences up to 13,000 nucleotides
• A significantly lower requirement (~10,000x) for plasmid DNA compared to standard mRNA manufacturing processes
• Highly reproducible process yielding mRNA with a homogeneous poly A tail and high performing product

Lipid Nanoparticle Formulation

Our portfolio lipids and custom lipid synthesis services help you bring your formulation to scale. As naked mRNA is unstable, drug delivery systems, such as lipid nanoparticles, are necessary to deliver mRNA to target cells. Selecting the right excipient and lipids is essential for successful encapsulation. We provide:

• Custom and portfolio lipids options for the different types of lipids you need to create stable LNPs and protect the mRNA, including synthetic cholesterol. Each LNP contains four different lipids to carry and protect the mRNA
• Excipients for liquid formulations, mineral salts, buffers, and stabilizers, all supported by the Emprove^® Program.
• Integrity testers to verify the integrity of sterilizing filters
• Filters for your final sterile filtration
• LNP formulation and fill and finish service through Exelead^® CDMO services

Cell Banking and Storage

Banking and storing your strains or plasmids are crucial parts of the mRNA manufacturing process. We offer banking and storage space for your stocks in various biorepository and storage facilities around the globe. You can also choose from our master viral seed stocks.

Facility Engineering Services

If you’re looking to build your own mRNA biomanufacturing facility, we can provide guidance in designing, building, and operating a safe and flexible GMP manufacturing facility. To learn more, download our guidebook “Break Down Roadblocks to Clinical Success.”

mRNA Testing Services

Our BioReliance^® testing services support you through every stage your mRNA therapy's journey. We’ll help you through the required testing for regulatory compliance including:

• Raw material testing including sterility testing, mycoplasma detection, bioburden testing, and more
• Rapid molecular detection including using next generation sequencing to confirm the identity of seed stocks DNA, and RNA
• Viral clearance testing for method development, validation, and regulatory requirements
• Bulk harvest release testing for unprocessed and purified bulk harvest
• Final product release testing for your final product packages
• Validation of filters, assemblies and single-use systems