Knauer has developed a technique for mass-producing lipid nanoparticles (LNPs) using impingement jet mixing technology (IJM). LPNs have been shown to be a suitable delivery form for the development of mRNA-based vaccines against Corona, and is at present being used to produce millions of vaccination doses a week by Pfizer. This technique has been shown to form a stable basis for the administration of active ingredients such as RNA, mRNA, siRNA, or DNA-based APIs.
The impingement jet technology uses a mixer which forces lipids into a small chamber under pressure, against an opposite flow of active ingredient, such as mRNA, also forced in under pressure. The active nanoparticles that are produced flow out of the third outlet.
The Knauer pumps used for mass-producing LNPs is the BlueShadow 80P; either the 100, 250 or 500 ml/min models, all with titanium fluid paths. Multiples of these pumps can be utilized at the same time, depending upon the output required. Knauer’s IJM skid for LNP production incorporates sixteen 8oP pumps, eight for the lipid injection and eight for the mRNA injection.
Impingement Jet Mixing Technology Skid
The IJM-Skid for LNP production contains eight parallel mixing units. Each unit consists of two pumps to deliver lipid and API streams, two flowmeters for flow control and one jet mixer. Pre-dilution of the API and quenching is performed for the combined flow of all eight units in one process step outside the IJM-Skid. The number of parallel units depends on the application. Also, the number of pumps, flowmeters, jet mixer and pipes can be adapted
to the required conditions and scale. All skids are built in a stainless steel frame on casters and are suitable for CIP cleaning procedure in pharmaceutical production.
- KNAUER high pressure dosing pumps 80P
- Coriolis flow meters
- KNAUER IJM-mixers
- Inlet manifolds for Lipid solution and API
- Outlet manifold for LNP solution
- Frame (Stainless Steel system 1.4301) incl. cable trays
- Technical Documentation
- Capillary Customization and labeling
- FAT (Factory Acceptance Test at KNAUER Berlin)
- SAT (Site Acceptance Test at customer site)
- Installation & familiarization by KNAUER
Impingement Jet Mixing Skid at Pfizer's Vaccine Manufacturing Plant
See how Pfizer has been using its IJT skid to produce millions of doses of mRNA-based vaccine a week in this CNN report (3′ 42″) – Pfizer vaccine: How one company makes its millions of Covid-19 vaccine doses – CNN