Scalable end-to-end manufacturing of mRNA lipid nanoparticles
Precise flow rates from 1 to 240 ml/min for continuous bioprocesses
The production of mRNA-based therapeutics involves a series of highly sensitive process steps, ranging from in vitro transcription (IVT) and enzymatic reactions to purification, encapsulation of mRNA into lipid nanoparticles (LNPs), and sterile filtration. Modern end-to-end manufacturing processes integrate these steps into a continuous production workflow, enabling automated manufacturing from preclinical development to commercial production.
To ensure consistent product quality, numerous process liquids must be delivered and dosed with high precision. At the same time, hygienic questions, validated materials, and reliable cleaning and sterilization procedures place demanding requirements on the fluid handling system.
What are the fluidic requirements for manufacturing mRNA lipid nanoparticles?
End-to-end production of mRNA lipid nanoparticles requires fluidic systems that reliably connect multiple process steps while maintaining stable operating conditions throughout extended production runs.
Key requirements include:
- precise flow rates from 1 to 240 ml/min
- continuous and reproducible delivery of aqueous media
- hygienic construction using FDA- and USP Class VI-compliant materials
- CIP- and SIP-compatible fluidics for validated cleaning procedures
- scalable process operation from preclinical to commercial production
- reliable continuous operation in automated manufacturing systems
A stable fluidic system provides the foundation for reproducible process performance throughout the entire manufacturing workflow of mRNA lipid nanoparticles and supports consistently high product quality.
How is fluid handling implemented in end-to-end manufacturing equipment?
The system utilizes mzr-6355 and mzr-7255 micro annular gear pumps from the hermetic inert series, specifically adapted for hygienic applications. Hygienic connections, FDA- and USP Class VI-compliant materials, and surface roughness values of Ra ≤ 0.6 µm meet the demanding requirements of modern biopharmaceutical manufacturing processes.
A heat insulation module protects the pumps during SIP procedures at liquid temperatures of up to 130 °C, while the volumetric operating principle ensures continuous and reproducible delivery of a wide range of process media, including buffers, DNA/RNA solutions, protein solutions, and cleaning agents.
The pumps can be integrated into continuous manufacturing equipment and support automated end-to-end processes ranging from in vitro transcription and buffer exchange to LNP encapsulation and sterile filtration.
What benefits does this provide for manufacturing mRNA lipid nanoparticles?
By integrating the micro annular gear pumps, the manufacturing equipment can:
- automate end-to-end manufacturing processes
- provide reproducible flow rates across multiple process steps
- ensure hygienic manufacturing conditions
- scale production systems from preclinical to commercial manufacturing
- increase process reliability and product quality
- support validated CIP and SIP procedures
Hermetic inert micro pumps enable hygienic, continuous, and scalable fluid handling for the manufacturing of mRNA lipid nanoparticles. They support automated manufacturing processes with reproducible flow rates throughout the entire production workflow.