Don’t Trust Your Lipid Nanoparticles to Anyone Else

Purity key to lipid storage and safety

Lipids, typically in the form of lipid nanoparticles (LNPs), are a key component in the delivery systems for messenger RNA (mRNA) vaccines. This includes vaccines from Pfizer and Moderna currently being used in the fight against COVID-19.

Lipids and other biological materials, including glycerides, cholesterols and proteins, can be very sensitive to chemical leachables from containers made of common bottle materials like polycarbonate and PETG. Leachables can also end up in the final product, jeopardizing patient safety.

Recent developments in LNP manufacturing now require the lipid to be supplied in an organic solvent (typically 90 percent ethanol). However, using these solvents increases the risk of contaminants being leached from commonly used polymer containers.

Fluoropolymers help lipids avoid chemical contamination

Fluoropolymer containers – such as Purillex^® ready-to-use bottles and vials from Savillex – are ideal for transport and storage of lipids, glycerides, cholesterols and proteins (and other sensitive solutions). Why? Because they do not contain chemical leachables that can contaminate your product.

 

Sample chromatograms comparing Purillex^® bottles (first graph) to standard PETG bottles (second graph). The second graph shows two PET cyclic trimer organic contaminants detected in PETG bottles after 28-day methanol extracts by HPCL/UV/VIS.

Purillex^® bottles are manufactured from PFA and ETFE fluoropolymers, which have high purity and extremely low leachables – even with aggressive solvents. Additionally, Purillex^® bottles are supplied pre-sterilized and ready-to-use.

To recap – the benefits of Purillex^® bottles and vials for LNP transport and storage include:

• Non-stick surface
• Inert to virtually every reagent chemistry
• Low extractables and leachables
• Single material in contact with product
• High integrity seal, no cap liner needed
• Available clean, pre-sterilized and ready-to-use
• Sizes from 3 mL to 2000 mL

Have a challenging application in mind that could benefit from our fluoropolymer bottles and vials? Get detailed technical info and explore the entire product lineup.

For additional information, or to obtain pricing, please give us a call today.