Understanding How mRNA Vaccines Are Produced

HPLC pumps used in the production of Lipid-based Nanoparticles (LNP) for drug delivery of mRNA-based vaccines 

 Although Chrom Tech specializes in chromatography supplies and consumables, historically, most of the HPLC pumps we have sold are for non-chromatography applications. Chrom Tech HPLC pumps have been used for years in process applications where customers need to deliver a consistent flow (or constant pressure) of a liquid for a chemical engineering reaction or production of product. We have customers who use a bank of our HPLC pumps for process applications. Because of the ruggedness of our pumps, these customers use our pumps 24/7/365 continuously for many years without complications. 

Today, these HPLC pumps are used in the fight against COVID-19 to produce lipid nanoparticles for the production of mRNA vaccines: 

Microfluidics is robust, scalable and very reproducible. It involves the mixture of lipids in an organic solvent with an aqueous phase containing the nucleic acid through a micromixer. The cationic lipid interacts with the negatively charged nucleic acid, resulting in high encapsulation efficiencies. LNPs of defined sizes can be accurately produced by controlling the microfluidic operating parameters such as flow rate ratio (FRR) or total flow rate (TFR). High production speeds (TFR) can be achieved using microfluidics, which results in a reduction in manufacturing time (up to 200 mL/min). (Roces et al.) 

Chrom Tech offers a line of HPLC pumps that is suitable for lipid nanoparticle production. We have dual-piston HPLC pumps that can deliver constant flows up to 300mL/min. Our HPLC pumps are available in various wetted materials. In addition to the primary fluid path material, Stainless Steel, or PEEK (for bio-applications), other wetted materials may include synthetic ruby, synthetic sapphire, ceramics, fluoropolymers, and UHMWPE. Stainless Steel fluid paths are most common with broad acceptance in HPLC, processing, and metering applications. Corrosion resistance, high-pressure capability, and general ruggedness make stainless steel the primary choice of materials. Pumps that are specified as PEEK (or biocompatible) have a fluid path that is fully non-metallic. 

Can Chrom Tech offer HPLC pumps that come with GMP-compliant material certificates? 

Yes! Good Manufacturing Practice (GMP) is a system for putting quality product first and minimizes the risk involved in pharmaceutical production. Chrom Tech is excited to announce that we now offer a premium line of HPLC pumps that come with GMP-compliant material certificates. Please reach out to Chrom Tech today to get a quote for an HPLC pump that is GMP compliant and shipped with GMP material certificates. 

GMP-Compliant Dual-Piston HPLC Pumps Include: 

1.Material traceability certifications provided for all fluid path components 

2.All fluid path surfaces of Stainless Steel components have a surface finish of 20 μ-inch Ra or better, typically achieved through electropolishing 

3.All polymer fluid path components are made from a material with USP Class VI certification (animal-free and other attributes). 

We realize that GMP requirements are not a one-size-fits-all approach; please reach out to Chrom Tech to discuss your GMP requirements. 

Chrom Tech HPLC Pumps for Trouble-Free Operations in Constant Flow Applications 

Our HPLC pumps are designed with ruggedness in mind. We understand that customers need consistent delivery of a constant flow for their reaction/process to be successful. When maintenance is required, end users can easily access the commonly replaced components of their Chrom Tech pump because the pump head is located on the outside of the pump chassis. Also, all Chrom Tech pumps are equipped with our innovative Self Flush feature, which dramatically increases seal life and improves overall reliability. Read our blog on HPLC Pump Care and Troubleshooting for best practices to keep your HPLC pump running trouble-free for years of operation.  

Chrom Tech Pumps in a production facility for over 20 years! 

In the early nineties, a production facility was looking to update their process, and they needed to deliver a constant stream of fluid to produce polysulfone fibers to, in turn, produce filters for blood and water filtration. Chrom Tech pumps were selected to pump diluent to a catalyst to produce the fiber for these filters. These pumps (pictured above) have been in production (24/7/365) for over 20 years! Then, in 2017, they needed to update/add production capability; again, Chrom Tech pumps were selected for their production.  

I recently had a conversation with the maintenance supervisor in charge of equipment uptime in the filtration production at this facility.  

“We can trust that the Chrom Tech pumps are consistent every time, that is really the reason why we went with Chrom Tech in the beginning, and then again when we needed to purchase another pump diluent line, and service, that’s really the key…. When they asked us as techs, I was not a supervisor at the time, if we were going to get more diluent pumps, what is your preference, the decision was clear Chrom Tech is always there, they have always supported us, we can get what we need, it was really the service side.