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Lipid nanoparticle (LNP) production equipment 

In connection with the development of mRNA-based vaccines against Corona, lipid nanoparticles (LNPs) have shown to be a suitable delivery form. LNPs encapsulate and protect the delicate active ingredient and allow its transport to the target cells in the human body. Corona vaccines are the first large-scale use of mRNA and lipid nanoparticles in vaccination history.

KNAUER, mostly known for its liquid chromatography systems, also supplies production equipment for pharmaceutical lipid nanoparticles. This development was made possible by combining the company’s expertise in high-pressure dosing and in laboratory systems engineering. 

New and promising developments in medicine make pharmaceuticals and their active ingredients increasingly complex and bring new challenges. Oligonucleotides, for example, are very susceptible to degradation in the human body. LNPs have shown that they can form a stable basis for the administration of active ingredients like RNA, mRNA, siRNA, or DNA-based APIs. These types of APIs and optimization of delivery to the target cells are a very vivid field of research. 

Lipid nanoparticles (LNP) for mRNA-based vaccines

KNAUER’s jet mixing technology has demonstrated outstanding performance for small and large-scale production of vaccine lipid nanoparticles. KNAUER supplies small desktop devices to users in research and development as well as complete LNP skids for the pharmaceutical industry.

The
systems for production, also called IJM skids (impingement jet mixing), are designed and optimized to meet customer's specifications and documentation requirements. System installations in clean rooms (class C) have been successfully carried out. The systems are equipped with all necessary interfaces for the integration into customer's own PLC (programmable logic controller) systems.

Award-winning IJM technology

equipment for your production Systems

Lipid nanoparticle production systems –
Interview with Dr. Paul Pietsch, Product Manager for LNP systems

1) What is the purpose of a lipid nanoparticle production system?

A lipid nanoparticle (LNP) production system is used to encapsulate mRNA or other delicate API with lipids. The lipid protection around the mRNA is needed to protect it from degradation and to enable the uptake into the body cells.

2) Which functionalities are important for lipid nanoparticle production ? 

The most important functionalities for high quality lipid nanoparticle (LNP) production systems are a very precise pumping technology, fast and reliable switching of liquids and close control of parameters via software and flowmeters. In addition, an elaborate mixing technology is required for high-efficiency LNP production. 

3) How is precision and performance controlled? 

The pump flow rate is continuously monitored by flowmeters and control software. The software executes control functions when critical changes in the flow rate are recorded. 

4) Why is KNAUER able to provide excellent LNP solutions? 

KNAUER has a high vertical range of manufacture. High-pressure metering pumps and valves for liquids have been core development competencies of KNAUER for decades. KNAUER employs a large number of specialized experts, enabling us to develop skids for LNP production together with customers. 
The products are manufactured in Berlin, Germany. That is why we enjoy a resilient and reliable supply chain. 
 

Modular process skids for controlled pumping and mixing in biopharmaceutical production

Together with users, KNAUER engineers design and build customized skids. Modular process skids have the advantage of easy transportation and flexible integration.

The Factory Acceptance Test (FAT) is performed by KNAUER quality assurance together with the customer. The Site Acceptance Test (SAT) can be approved at the customer's lab or production facility.

Modular Process Skid for controlled pumping and mixing of biopharmaceutical production

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