Mini-Fluidic GMP Systems for mRNA & DNA

GMP manufacturing at millilitre scale

mRNA, synthetic and plasmid DNA, and gene and personalized therapies are increasingly produced in GMP runs at flow rates of mL/min rather than L/min.

At this scale, any oversizing, such as using conventional 1/8-inch equipment where 1/16-inch would be more appropriate, can significantly compromise process performance. It introduces control instability, response delays, excessive dead volumes, cumulative product losses at each step, and unwanted dilution, ultimately reducing overall process efficiency and product recovery.

VERDOT small-scale GMP system in a compact cabinet

A core VERDOT expertise since 2017

2017

Mini-fluidic bioprocess engineering has been a core expertise of VERDOT since 2017.

1/16″

Flow paths sized for mL/min flow rates, where conventional equipment would use 1/8 inch.

8 mL

Columns as small as 8 mL on our single-use chromatography system with Ultra Low Flow kit.

Purpose-built systems

We design and develop optimized single-use and multi-use fluidic systems tailored to small-scale bioprocessing: enzymatic reactions, chromatography, and depth and tangential flow filtration.

Our own components

Where conventional solutions fall short, we engineer GMP-compliant aseptic diaphragm and pinch valves, as well as specialized fluidic elements, to ensure optimal performance at every scale.

Our philosophy is simple: we engineer fluidic solutions around your process, rather than forcing your process to adapt to off-the-shelf technologies.

What we have delivered at small scale

Complete system

All-in-one mRNA production system

From IVT to encapsulation, engineered into a compact, cabinet-sized skid and delivered 9 months from design.

Chromatography

FlexiPro™ Chromatography with Ultra Low Flow kit

A single-use chromatography system running on a 1/16″ tubing flow kit, for columns as small as 8 mL and linear gradients in challenging separations.

Patented component

Sanitary mini-valves

Modular diaphragm valves for 1/16″ to 1/8″ GMP flow paths.

Engineering low-volume GMP flow paths

A valve that did not exist

Working on client projects at millilitre scale, we found that no multi-use GMP valve existed for mini-fluidic lines of 1/16″ to 1/8″ internal diameter. Available valves could not combine aseptic design, no dead legs, suitable flow velocity, low pressure drop and minimal hold-up volume.

So we developed and patented our own: a modular diaphragm valve platform for small-scale GMP processing. Valves assemble side by side into compact straight-through or T-valve configurations with minimal dead volume, membranes are quick to replace, and the latest generation integrates position and end-of-stroke sensors.

Multi-use
Patented mini diaphragm valve

Single-use
Mini valves on a tubing flow kit

Why small scale is different

The valve is typical of the work. Hygienic design rules and off-the-shelf components were developed for larger pipe sizes. At a few millimetres of internal diameter, effects that are negligible at production scale become critical:

Yield

Hold-up, dead legs and drainability can decide the yield of a small batch.

Pressure and shear

They rise sharply in narrow flow paths, limiting flow rates and stressing fragile molecules and LNPs.

Accuracy

Flow, dosing and sensor accuracy degrade at very low flow rates.

We deal with these at design stage, through 3D and dynamic flow modelling, flow-path geometry optimized for minimal hold-up and full drainage, and components selected for their accuracy at low flow.

“Miniaturizing advanced bioprocesses is not about shrinking equipment, it’s about reinventing fluidics to overcome the challenges of pressure, concentration, separation, and process control.”

Sébastien Lefebvre
VP, R&D Director, VERDOT

Your process. Your methods. Our engineering.

By the time our customers approach us, they have already developed and validated their key process choices, from enzymatic reactions and chromatography strategies to buffer selection and diafiltration conditions, through laboratory, pilot, or preclinical development.

Our mission is not to reinvent their science, but to translate it as faithfully as possible into GMP-ready equipment at the required scale. We engineer bioprocessing solutions around our customers’ proven methods and molecules, not the other way around.

Typical applications

Synthetic and plasmid DNA

Enzymatic synthesis and purification of DNA templates, and purification of plasmid DNA, from process development through to GMP lots.

mRNA

In vitro transcription, purification, concentration and buffer exchange for clinical batches, including diafiltration of mRNA-LNPs.

Cell and gene therapies

Small or patient-specific GMP batches, processed in closed systems with minimal product loss from one unit operation to the next.

System capabilities

Technology building blocks

Scalable enzymatic reactor based on bags, with scalable mixing, precise temperature control, and high-accuracy enzyme and buffer dosing from a few microlitres to several hundred millilitres
Patented modular sanitary mini-valves with position and end-of-stroke sensing
Single-use or reusable low-volume flow paths
Chromatography and tangential flow filtration at millilitre scale
Inline PAT: pH, conductivity, UV and temperature, with optional spectroscopy
Automation and software: recipe control, audit trail, MES and LIMS connectivity

GMP compliance and validation

Designed to support GAMP 5 and 21 CFR Part 11
USP Class VI materials, with extractables and leachables documentation
Validation support: URS, FS, IQ and OQ
Integration with plant systems, MES and LIMS
Design, manufacturing and validation under one supplier

How to start a project

01

Design-feasibility study

Working sessions with our engineers to map your unit operations and define the system. You receive a specification and a quotation.

02

Design partnership

For workflows that no standard equipment covers yet. Our engineers develop the system with your team and test it on your process against agreed success criteria, with the data shared.

03

Custom GMP system

Your system is built and validated by VERDOT, ready for GMP manufacturing.

Discuss your process with our engineers.

Speak to our team of experts

Mini-Fluidic Bioprocess Engineering