Lyophilization services: so cool; it’s hot

Freeze drying, lyophilization, and cryodesiccation are all terms used to describe the process of removing water from a sample at low temperature. Though this technique seems to be a modern technology, people have been practicing freeze drying for preservation of perishables since prehistoric times (1). Lyophilized plasma was used to treat soldiers in World War II, and many kids (and adults) have enjoyed eating freeze-dried astronaut ice cream since the Apollo moon missions in the 1960s and 1970s.

What is lyophilization and why is it useful?

Lyophilization is a process that removes water from a sample or product by freezing and placing it under a vacuum. It relies on a phenomenon known as the triple point of water—the combination of temperature and pressure where three states of water (solid, liquid and gas) co-exist and are equally stable. The lyophilization process typically involves three stages (Fig 1):

1. Freezing
2. Primary drying
3. Secondary drying

 

Fig 1. The process of lyophilization involves three stages that remove water from a sample by freezing it and placing it under specific vacuum pressures and temperatures.

 

Lyophilization is used in diagnostics, pharmaceuticals, and other life science industries because of its many benefits. These benefits include maximizing product or sample stability and shelf life and maintaining chemical or biological function of molecules during long-term storage. Lyophilized products are also easy to transport and store because they are stable at ambient or room temperatures and do not need cold chain transportation or cold storage.

For diagnostics products, lyophilization is particularly attractive for point-of-care (POC) assays. Lyophilized reagents can be incorporated into tools and tests that require minimal training to run. For example, the reagents could be built into diagnostic cartridges that are loaded into a machine for analysis after a sample is added. A user may only need training on how to add the sample. There’s low risk for user error and a greater likelihood of accurate diagnosis.

Stepping up sustainability

Although lyophilization technology is not new, it is currently rising in popularity because of the worldwide interest in sustainability. Freeze-dried products have smaller volumes and lighter weights than their liquid equivalents, which means lower carbon emissions during shipping. The thermostable products can be shipped without dry ice, which eliminates the energy cost of producing dry ice and the sublimation of CO2 into the atmosphere. And, of course, no polystyrene is needed. Energy is further conserved because the products can be stored at room temperature and don’t need to be stored in refrigerators or freezers either before or after shipment.

Using lyophilized products also reduces reagent waste. Liquid reagents may need to be thawed and frozen between uses, and some volume is usually lost during dispensing. So, a diagnostic kit may claim to be enough for five tests, but a user may only be able to perform four tests. A kit with lyophilized reagents can have them all predispensed in assay containers and none will be wasted.

A big upgrade for our lyophilization services

Cytiva has been providing lyophilization services for many years, and we’ve seen an increase in demand for the service. To respond to this demand, we’ve invested in a new freeze dryer. And it’s big. Big enough for a person stand inside! Our other freeze dryers are the size of a refrigerator, and our new one is about twice that size.

One of the benefits of this new freeze dryer is that it can handle much larger batch sizes for contract manufacturing. Larger batches mean your product is produced quicker and with less variability. Another benefit is that it gives us more flexibility to meet your specifications. It can accommodate larger containers and a greater variety of vessels based on your requirements.

Our new freeze dryer is an example of our dedication to continuous improvement to better serve you, our customers. To accommodate the new freeze dryer, we had to build a new lab at our Cardiff, UK location. We also refurbished our smaller, R&D lyophilization lab so that we can support you during product development to prepare your assay for production. We have you covered from start to finish!

The future of freezing

The global lyophilization market grew significantly from 2012 to 2021 with a compound annual growth rate (CAGR) of 4.9%. The market is expected to grow even more with a predicted CAGR of 8.8% between 2022 and 2032 (2). POC diagnostic assays will be part of that growth. The demand is strong for PCR assays and there is growing interested in developing loop-mediated isothermal amplification (LAMP) assays. These assays can be made with lyophilized reagents for rapid, easy, and accurate diagnoses.

With the addition of our new freeze dryer and our refurbished R&D lab, Cytiva is ready to provide lyophilization services to diagnostic kit developers in the years to come.

Learn about lyophilization services.

Learn more about other Diagnostic Services from Cytiva.