Application of freeze-drying in diagnostic reagents

Freeze-drying is known for improving the preservation of raw materials for cosmetics, nutraceuticals, agri-food and life sciences.  This drying process removes water from products at low temperature. Freeze-drying therefore makes it possible to process and preserve delicate substances such as diagnostic reagents. They are difficult to preserve, as heat can alter them, and bacterial growth can contaminate them. Freeze-drying makes it possible to manage the properties of molecules that may be labile or reactive, by stabilizing the reagents.

Diagnostic reagents that can be freeze-dried by Groupe Berkem are used for conducting in vitro tests. Including:

Freeze-drying reagents for blood analysis laboratories

Reagents are needed to identify certain pathologies in blood samples. They can be used to detect specific substances in a mixture and provide a precise diagnosis. When these are detected, the reagents trigger a reaction which can take several forms, such as a precipitate, color change or gas emission.

Freeze-drying reagents for self-tests

Reagents are also used in various clinical tests to screen for certain diseases or pathologies. Reagents may react with the substance being tested in urine (e.g.: pregnancy tests), secretions (e.g.: COVID-19), saliva (e.g. drug screening) or breath (e.g. breathalyzer).

Freeze-drying serums

Serums are used in laboratory medicine for cell culture. They can be of animal or human origin. They are used for their concentration of trace elements and hormones, and for their growth and adhesion factors.

Products in the freeze-dryer

Advantages of freeze-drying in diagnostic reagents

There are several advantages in freeze-drying diagnostic reagents:

  • Freeze-drying stabilizes diagnostic reagents which are delicate substances. Since they are subject to degradation factors and are sensitive to external stimuli, such as heat, which encourages microbial growth, freeze-drying considerably extends their shelf life
  • Such stabilization preserves the initial properties of the molecules, which may be labile or reactive
  • When the diagnostic reagent is freeze-dried, Groupe Berkem vacuum seals the product in a vial. This is an important step, since its purpose is to expel as much air as possible from the product so that it can be preserved for even longer
  • In addition, a stream of nitrogen (a dehumidified neutral gas) can be used to freeze-dry the reagent. This technique consists of expelling the air in the reagent and replacing it with nitrogen. This technique further extends reagent shelf life
  • Groupe Berkem also crimps vials. This process provides the container with necessary protection, as it seals the vial and protects the freeze-dried reagent from any leakage or contamination during transportation and storage.

Groupe Berkem, a specialist in freeze-drying diagnostic reagents

Groupe Berkem has built one of its many areas of expertise around custom freeze-drying. The industrial plant, based in Chartres, can process a wide range of products to meet the needs of different markets. Groupe Berkem’s production facility has: 1 cryogenic grinder, 2 other grinders, 1 sifter and 12 freeze dryers of various capacities (maximum capacity 200 kg). These tools operate 24/7. The work area is ISO 7-classified, enabling services to be carried out in a controlled atmosphere, and it manages relative humidity.

Analyst performing tests before freeze-drying the product

Customized support for every project

Groupe Berkem is committed to implementing strict, rigorous procedures for its customers to guarantee compliance with the quality charter, costs and deadlines. A technical team of scientific and regulatory experts provides customized support to meet the specific needs of each project. Project follow-up is customized from the definition of requirements right through to delivery.

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