More stable reagents. More accurate dosages. Controlled industrial production.

 

In the field of in vitro diagnostics, every detail counts.

Even the slightest variation in dosage, a loss of enzymatic activity or the degradation of biomolecules can affect the sensitivity, reproducibility and reliability of the test.

 

At Lyophitech, we have developed a deep-freezing and freeze-drying technology specifically tailored to the requirements of manufacturers of diagnostic kits, molecular tests, immunodiagnostics and next-generation diagnostics.

Our aim is simple: to ensure that every freeze-dried bead delivers exactly the expected quantity of active ingredient, whilst preserving its biological activity over the long term.

 

 

 

 

 

 

Technology designed for precision

 

 

Thanks to our HelixSpin® bead-forming system, integrated into our MiniDyn® equipment, every drop becomes a perfectly controlled dosage unit.

The stream of liquid nitrogen ensures instant deep-freezing, which immediately locks in the composition of each bead without any migration or segregation of the constituents.

 

This gives you:

•    excellent homogeneity between beads;

•    extremely precise per-unit dosing;

•    perfect reproducibility from one batch to the next;

•    a reduction in losses of raw materials, which often have very high added value.

 

This approach is particularly well-suited to reagents used in immunodiagnostics, molecular biology, PCR, qPCR, syndromic diagnosis, rapid tests and decentralised diagnostics.

 

 

 

Preserving the biological activity of reagents

 

 

Enzymes, antibodies, proteins, nucleic acids and other biomolecules used in diagnostic tests are particularly sensitive to fluctuations in temperature, humidity and oxidation.

Our process has been designed to minimise these constraints throughout the entire procedure.

Instant freezing reduces denaturation caused by the formation of ice crystals.

 

Dynamic freeze-drying ensures uniform sublimation, without localised overheating, in order to preserve the most fragile biological structures.

Operations can be carried out under a controlled atmosphere to limit exposure to oxygen and humidity, thereby improving the stability of the most sensitive reagents.

Maintaining low temperatures throughout the process also helps to preserve the analytical performance of the final product.

 

 

 

Production tailored to diagnostic requirements

 

 

Our solutions support the development of new reagents from initial trials through to industrial production.

 

They meet the manufacturing needs of:

•    in vitro diagnostic (IVD) kits;

•    PCR and qPCR reagents;

•    immunological tests;

•    diagnostic enzymes;

•    antibodies;

•    recombinant proteins;

•    quality controls;

•    analytical standards;

•    point-of-care tests.

 

Thanks to their modular design, our systems integrate easily into regulated production environments.

 

 

 

Automation designed for manufacturers

 

 

The complete separation of deep-freezing and freeze-drying enables the production flow to be optimised.

Whilst one batch is being freeze-dried, the pellets for the next batch are already produced and frozen.

This approach significantly reduces downtime and increases equipment utilisation rates.

Our solutions also include:

•    automated loading and unloading;

•    a fully contained process that minimises the risk of contamination;

•    operations under a controlled atmosphere;

•    CIP/SIP systems for reproducible cleaning;

•    advanced automation enabling the simultaneous control of multiple units.

 

 

 

Accelerate the development of your reagents

 

 

Each diagnostic test has its own specific formulation, stability and dosage requirements.

Our teams support you throughout your process development to define the freezing and freeze-drying parameters best suited to your reagents.

The aim is to guarantee precisely dosed beads, excellent storage stability and preserved biological activity, whilst ensuring reproducible industrial production.

Because in diagnostics, the accuracy of a result depends on the accuracy of the process.