mRNA Vaccine and Therapeutics Manufacturing

The ability to deliver mRNA molecules into the cytosol of a patient cell offers possibilities for a new class of therapeutics to meet patient needs. The power of these versatile molecules to stimulate patient immune responses was clearly demonstrated with the success of COVID-19 vaccines.

Development of mRNA products is relatively straightforward and offers the possibility of rapid, scalable manufacturing using available technologies. The simplified manufacturing workflow through an enzymatic process minimizes the need for extensive process optimization and enables GMP facilities to quickly switch to new target mRNA products.

mRNA products, both therapeutics and vaccines, offer exciting possibilities for new patient treatments but require important considerations:

• Reliable DNA Template for mRNA Production:
  mRNA production begins with generation of a purified plasmid DNA (pDNA) template. Efficient pDNA separation relies on high-quality chemicals for bacterial cell lysis and purification of pDNA from impurities that could impact mRNA production. mRNA generation from the pDNA template depends on high-quality chemicals and reagents for plasmid linearization, in-vitro transcription, and end capping of the RNA.
  
  
• Optimized mRNA Purification to Maximize mRNA Yield and Recovery:
  Downstream purification removes endotoxins and nucleic acid impurities that impact RNA stability and induce immune responses in patients. mRNA manufacturers commonly rely on tangential flow filtration (TFF), reverse-phase ion-pair, anion exchange (AEX), hydrophobic interaction chromatography (HIC), and affinity chromatography using poly(dT) capture to purify mRNA while maximizing yield and recovery. Easy access to high-quality downstream equipment and chemicals is key to minimizing degradation and establishing an efficient purification process.
  
  
• Efficient mRNA Delivery with Lipid Nanoparticles:
  Lipid nanoparticles (LNPs) protect mRNA from degradation and enable efficient delivery of the molecule when administered to patients. The right lipid type, source, and quality for the LNP needs to be carefully selected based on the delivery route to achieve the desired biodistribution and efficacy profile.
  
  
• Dedicated Support for Risk Assessment and Regulatory Compliance:
  An important aspect of new product development is to navigate the regulatory framework, manage risks, and improve manufacturing processes. Reliable technical and regulatory information coupled with a well characterized and transparent supply chain minimizes risk, simplifies risk assessment, and accelerates speed to market.

For high-quality raw materials for mRNA manufacturing and LNP formulation explore also our brochure.