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The freeze-thaw cycle has enabled pharmaceutical manufacturers and biopharma researchers across the world to streamline their product supply.
The method is as simple as it was when it was first discovered; products remain at their steady state for long periods of time if frozen at a particular temperature (freeze) and only brought back to ambient temperatures when they’re required for use (thaw).
The parameters around the freeze-thaw cycle have evolved drastically, alongside that of the life sciences R&D sector, to coincide with the individual requirements of any chosen product.
Cryopreservation, for example, involves the preservation of biological constructs such as living cells, tissues etc. Although this avenue in particular has raised eyebrows about the possibility of preserving an intact, living, human-sized sample… for the time being, the freeze-thaw cycle is still primarily focused on ensuring the delivery of pharmaceutical products and the development of medical research.
Why do pharmaceuticals need to be freezer stored?
Particularly in the drug manufacturing sector, the stability of stored products can be affected by the temperature of the incubating chamber. To preserve microbiological stability, drug products may need to be kept at ultra-low temperatures to maintain the resistance of the sample against microbial growth.
The active pharmaceutical ingredient in any stored product must also maintain chemical integrity in order to be suitable for future use after thawing. The same can also be said for the physical stability of a product, whereby solubility, size and other features should remain the same after a bulk freeze.
Preservation of these products allows for the creation of a large inventory for pharmaceutical manufacturers, which ultimately increases their flexibility to serve the medical requirements of the general public and ensure a commercially sound business model.
Stage one: The freezing process
Much like when preserving food, we opt for the kitchen fridge as the best gatekeeper for tomorrow’s midnight snack, certain drug products are less likely to suffer from contamination and remain in a stable state if reduced to the glass transition phase or lower. It is also at this phase that metabolic processes stop.
The freeze-thaw cycle has evolved to become an efficient and effective preservation method for bulk product storage, with freeze-thaw chambers offering uniform cooling, maximised space and compatibility with various containers.
Modern ultra-low temperature storage solutions have resulted in products being stored at temperatures as low as -80°C to -200°C, which meant that a method of placing new products into storage was required. This is where the blast freeze entered the lifecycle, which has now been adopted by many pharmaceutical labs.
Why do finished products require blast freezing?
A blast freezer’s duty is to ensure that the ice crystals that form during freezing are as small as possible to reduce the amount of moisture that would be released during the thawing process. The longer it takes to freeze a product, the chances of larger crystals increase.
Blast freeze-thaw cycles are common in the biopharma industry as they minimise product loss as well as degradation of integrity, which ultimately gives researchers and manufacturers a better-quality product to work with.
The benefits of a blast freezer chamber:
As well as product stability, freeze-thaw chambers such as the FARRAR 4000 Series offer uniformity and repeatability. Conventional freezers often suffer from ‘hot spots’. The blast freezer thaw chamber, however, is built to ensure that there is a controlled reduction in temperature by employing forced air circulation technology.
Earning the title of control rate freezer, the FARRAR freeze-thaw chamber is a primary example of how technology has advanced to allow for rapid, controlled freezing which eliminates temperature and product uncertainty. This allows the biopharma sector to:
- Save valuable laboratory time; by reducing the overall time taken for products to reach ultra-low temperatures.
- Maximise space available in a chamber; by using forced air circulation, products can be stored closer together allowing for bulk storage.
- Streamline production and shipping processes; with a repeatable ‘time to temperature’, manufacturers can process more products and optimise workflows. In the FARRAR system for example, it takes less than 12 hours to reduce a 100-litre load to an ultra-low temperature.
- Act more sustainably; freeze-thaw chambers are designed for rapid freezing so they will lower temperatures evenly and more economically than a typical ULT freezer.
- Preserve product viability; a control rate freezer is the most effective way of managing the freezing process, which allows scientists to remove water from product cells to prevent intracellular ice formation.
Stage two: thawing required products
Once a batch of drug products has been reduced to an ultra-low temperature, they’re either stored or shipped. Researchers will often store samples until they’re required for use, while manufacturers will more than likely blast freeze prior to shipment.
Either way, the product will need to be brought back to ambient temperature after the goods are received and/or ready to be used. Because who eats leftovers without zapping them in the microwave first?!
Current methods of thawing finished products tend to lean more towards manual efforts. With many facilities relying on still water immersion thawing, utilising warm water baths, and others opting for room temperature thawing, whereby required products are brought out of the ULT freezer ahead of a pre-empted research schedule. This can be anything up to days or weeks in advance.
The consequence of manual thawing, however, is that an accurate product temperature cannot be reported during the thawing process, with automation and uniformity both lacking.
The benefits of a control rate freezer:
A control rate freezer, like the Series 4000LC by FARRAR, provides bulk thawing at a rapid rate through air or water condensers. This kind of advancement in technology has meant that graphical displays of the chamber and the current temperature can be provided. Ultimately enabling an automated lab process of product preparation.
A solution of this kind can also handle up to 100L in the same chamber, which means that repeat freezes are avoidable. Here, manufacturers are able to preserve microbiological stability on a larger scale, facilitating storage of bulk inventory. Lastly, fast, uniformed thawing also has a positive effect on the integrity of any given pharmaceutical product.
As temperature specialists, the lifecycle of any pharmaceutical product is as important to us as the research project it is a part of. This is why we provide a freeze-thaw chamber which embodies a control rate freezer, a blast freezer and an automated thawing process that can increase yield rates from 40% to 90% and reduce thaw conditioning to hours rather than days to further transform the lifecycle of the product.
