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Lyophilization: eliminating the need for cold chain logistics

Lyophilization, also known as freeze-drying, is a process being increasingly adopted by in vitro (IVD) assay developers looking to simplify assay handling and storage.

With the challenges of sustainability and the escalating cost of cold chain logistics, lyophilization provides an efficient, effective alternative means of maintaining assay stability.

In this article, we will explore how lyophilization overcomes the challenges of cold chain, its advantages and disadvantages, the different formats available and the potential for outsourcing lyophilization services.

How can lyophilization overcome the challenges of cold chain?

Cold chain logistics involve the transportation and storage of temperature-sensitive reagents, at a specified and often extremely low temperature. This can be complex, impractical, and expensive. The need for continuous temperature control and monitoring throughout the supply chain can lead to increased risk of product degradation, reduced performance or even complete loss of assay functionality.

Lyophilization offers a solution to these challenges by removing water from the product to the point where it is no longer biologically or chemically active, producing a dry product that can be transported and stored at ambient temperature.

Advantages and disadvantages

Lyophilization presents several advantages over traditional cold chain storage.


Primary benefits include:

  • Extended product shelf life: By removing water, lyophilization can significantly prolong the shelf life of assays, enabling permanent storage at ambient temperature without loss of performance.

  • Reduced transportation and storage costs: Eliminating the need for refrigeration and temperature-controlled supply chains delivers significant cost savings in transportation, storage and handling.

  • Maintained product integrity: Lyophilization reduces the risk of product degradation during transportation and storage, ensuring that the assay maintains its intended performance.

  • Enhanced global distribution: The ability to store and transport lyophilized products allows easier distribution to remote areas, particularly in less developed economies with limited infrastructure.

  • Substantial reduction in CO² emissions: By obviating the need for refrigeration  the environmental impact of assay transportation and storage is decimated. There is no need for dry ice, there is less energy consumption and less packaging.


Whilst the benefits are compelling, the lyophilization process itself presents some challenges that need to be carefully considered:

  • Higher upfront costs: While the long-term savings will be substantial, the initial investment in lyophilization equipment and expertise may be higher than traditional cold chain methods.

  • Complexity of the process: The lyophilization process requires specialised knowledge and skilled technicians to optimise the assay design and ensure product quality and consistency.

  • Not suitable for all products: Certain products may not be amenable to lyophilization.


Despite this, lyophilization remains a cost effective, sustainable and practical alternative to cold chain logistics, particularly in cases where the transportation and storage of temperature-sensitive products is challenging.


Lyophilization formats

The most common formats for assay and reagent lyophilization are as a “cake” (in a vial or plate) or as a “bead”.

  • Lyophilized “cakes”:Lyophilizing reagents as a “cake” is the process of freeze-drying the formulation directly in its final container. This approach minimizes risks associated with product transfer

  • Lyophilized “beads”:Lyophilized beads are customisable spheres containing an accurately measured single dose of formulation. As they are single dose, they do not need aliquoting, which presents additional benefits such as dose consistency, a reduced risk of contamination and less wastage.

Outsourcing lyophilization

For many organisations, outsourcing lyophilization to specialist contract manufacturers can be the most flexible and cost-effective way to meet their needs. Outsourcing lyophilization offers many benefits, including:

  • Instant access to specialized expertise: Contract specialists will have skilled technicians with time-served expertise in the lyophilization process, including analytical techniques such as Freeze-Drying Microscopy and Differential Scanning Calorimetry. They will also have extensive experience of the effectiveness and behaviours of specific excipients and buffers.

  • Reduced capital investment: By outsourcing, assay developers can avoid the high upfront costs of purchasing and maintaining sophisticated lyophilization infrastructure such as freeze dryers and formulation dispensing equipment.

  • Scalability: Contract manufacturers typically have the capacity and resources to accommodate a wide range of production scales, from small-batch research projects to large-scale commercial production. This allows organizations to scale production as needed without having to invest in additional equipment, facilities or people.

  • Regulatory compliance: Outsourcing to a modern and flexible contract provider ensures that the lyophilization process adheres to the relevant regulatory standards. This reduces the risk of issues further down the line and ensures that the product is safe and effective for its intended use.


Why Biofortuna?

As a lyophilization specialist, Biofortuna has extensive experience and a proven track record in the development and large-scale manufacture of molecular PCR, LAMP and immunoassays and stabilization of immunodiagnostic reagents.

They listen to your requirements, develop customized solutions and deliver them with openness and transparency.

Operating from state-of-the art, purpose built premises and hold ISO 13485 and ISO 17025 accreditation and FDA registration. We work with complex formulations (including NGS reagents, micro spheres, paramagnetic particles, latex and colloids) and bio conjugation reactions with enzymes, antibodies and molecular probes.


The scientific team has experience in a range of assay technologies including:


  • Polymerase chain reaction (PCR)

  • Quantitative multiplex polymerase chain reaction (qPCR)

  • Reverse transcription polymerase chain reaction (RT-PCR)

  • Next generation sequencing (NGS)

  • Isothermal nucleic acid amplification technology (iNAAT)

  • CRISPR-Cas9 and TALEN-based gene editing

  • Microarrays

  • Digital droplet polymerase chain reaction (ddPCR)

  • Biosensors

  • Immunoassay (ELISA)


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