High-precision LNP mixing systems for mRNA vaccines delivered across Europe and the USA.

Compact mobile skids with synchronized micro-scale flow control enable reliable mRNA-lipid nanoparticle production and seamless global deployment.

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Advanced LNP-mRNA mixing systems. Six mobile units engineered for global deployment.

Lipid nanoparticles (LNPs) are one of the most advanced technologies for efficient in vivo delivery of mRNA therapeutics and vaccines. ZETA supported a manufacturer in the development of an mRNA-lipid nanoparticle mixing system and delivered six identical mobile skids for high-precision mixing to the customer’s sites in Europe and the USA.

The challenge

The customer requested an optimization of an existing mixing system for the preparation of the mRNA-lipid nanoparticle product. The system was required to provide high precision mixing, dilution and collection of input solution streams. The volumes of substances to be processed are in the milliliter range, requiring a complex piping system with small diameters. A major technical challenge was to align and synchronize the pumps to accurately achieve the required mixing ratio and maintain a defined flow through the pipework.

The solution

ZETA carried out process and detail engineering of the high-precision system based on P&IDs and functional specifications provided by the customer. Piping routing was an important consideration in the 3D design: pipe lengths, bends and associated pressure losses were carefully balanced to achieve consistent and synchronized flows.

The basic components of the skids included peristaltic pumps, single-use filter capsules, a mixing tee provided by the customer, and cleaning-in-place equipment. Flowmeters control the pumps, which are positioned at a specific angle to provide optimum draining of the integrated SU assemblies.

Following a master-copy approach, ZETA built six identical compact and mobile skids. Despite the challenges posed by the small diameter of the pipes (DN8), the welding engineers provided high-precision welds. Welding defects, which would have resulted in particle clogging and product loss, were carefully avoided.

In addition to testing the functions, the FAT enabled further optimization of the integrated CIP system. The supply of a media storage system and its connection to the mixing skids was part of a follow-up project.

Services

The high-precision system was designed to be compact and mobile. Six identical skids were built and delivered to the customer's sites in Europe and the US.

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Matthias Goriupp

Director Business Line Customised Systems

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