Diagnostic Reagents
Freeze Drying of Diagnostic Reagents
Freeze drying is a cornerstone technology in the manufacturing of diagnostic kits, particularly for stabilizing the bioactive components such as enzymes, antibodies, antigens and oligonucleotides (primers/probes) etc. These biomolecules are highly sensitive to degradation in liquid form, which can lead to loss of activity and inconsistent test performance over time.
Lyophilization converts these critical reagents into stable, dry powders, and preserves their bioactivity and extends shelf life. This process not only ensures the reliability and accuracy of point-of-care tests but also enables the pre-distribution of reagent doses into reaction wells or cartridges.
Lyophilized Benefits
Freeze drying process starts from freezing the raw products, and then move them into an air-tight chamber, vacuumize the chamber to create negative pressure environment. Under vacuum, solid water (ice form) absorb heat from environment and sublimate directly to vapor phase, it is a low temperature dehydration method.
Freeze drying is processed under vacuum and water is removed from solid state to vapor state, which means raw materials always in minus temperature. The low temperature drying prevents protein denaturation and enzyme deactivation, ensuring the binding activity of antigens and antibodies, safeguarding the sensitivity.
Drying under vacuum prevents oxidation and final product water contain is extreme low less than 3%, by optimize the lyophilization process and formulation of lyoprotectants, freeze dried products can be stored for years at room temperature, which significantly reduces transport and storage cost, risks and limitations that rely on cold chain logistics.
Vikumer freeze dryers automatically record key parameters in freeze drying, and user can select more powerful SCADA system that with functions like e-signature, audit trial etc. Enhance the data authenticity and traceability.
Vikumer freeze drying system offers exceptional performance on the temperature control, temperature difference between shelves and shelf points less than 1C, this ensures consistent results between shelves and between batches, which also means consistently quality guarantee.
Drying Examples
Freeze drying improves the stability of reagents and diagnostic materials, ensures consistent performance and enable long-term storage. Application and drying examples including but not limited to:
- Microwell plate and reaction tube:
- Products are dried in 96 well plates, elisa plate, centrifuge tube etc.
- Vials and tube bottles:
- Products are dried in different type/size vials, double chamber vials, syringes etc.
- Bio active ingredients:
- Enzymes, antigens, antibodies, extracts etc. drying in bulk.
Solution for Different Stages
From pilot test to commercial production, we provide freeze drying solutions for all stages, guarantee your technology transfer breezily and ensure the consistent results.
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