In biopharma and similar industries there is a lot of talk about the process of freezing: This process brings drug substances into a frozen state to allow for protected, safe and reliable storage and shipping.
It depends on the drug substance at what process steps and at what temperature it needs to be frozen in order not to get degradated. The most recent accomplishments in COVID-19 vaccine clinical trials and the raised discussions of required temperature for storage are solely about the storage temperature after fill & finish in final syringes and vials. There will still be need for ultracold freezing to -80°C in the bioprocess manufacturing process steps ahead until the vaccine is being filled into syringes and vials for global supply.
However, the medial anxiety about freezing biopharmaceuticals to ultracold sub-zero temperatures between -60°C and -80°C has only shown that established technologies do not fulfill industry requirements and are not well-trusted yet. To date, the methods employed often involve traditional freezing and cooling systems that usually are, however, not the most efficient ones. The utilization of static freezers is responsible for up to 56 % of viral potency product loss in biopharmaceutical manufacturing.(1) This almost incredible percentage is the result of a slow and inefficient procedure that leads to an inhomogeneous result.
Highly complex and technically progressive environments with a focus on speed and quality, traditional freezing processes are, generally speaking, no longer appropriate. They prove to be more and more inefficient as they only slowly drain the heat from the product, thus leading to an inconsistently frozen substance. What is needed are efficient systems based on elaborate, cutting-edge procedures that are tailored to push productivity by freezing biopharmaceutical substances evenly and without any product loss.
Read on to find out how Single Use Support’s promising approaches are gaining traction and why the systems from the industrial solution provider are set to become an indispensable part of any progressive, advanced lab or company.
The issue of a slow cooling- respectively freezing process is inherent to standard freezing systems like traditional static freezers. This so-called “slow freezing” is primarily characterized by differing freezing rates with a possibly adverse impact on the drug substance’s quality. A slower freezing process leads to the formation of longer ice crystals, which can harm the product. The formation of crystalline structures furthermore causes tension, which in turn can destroy up to 20 % of all contained proteins. And as the cold temperatures penetrate the substance from the outside in, this can lead to an expansion of the core with the result of harming or destroying the surrounding material.
A speedy freezing process is required for even and homogenous results that aren’t detrimental to the high-quality and at times highly sensitive substances. It is thus hardly surprising that 89 % of biopharmaceutical companies claim to be in the market for a freeze-thaw platform that allows them to freeze (and thaw) their substances safely, purposefully and evenly.
Such a process will not only prevent the process of crystallization. In addition – and as important – a swift and purposeful freezing process thwarts potential contamination and product loss: The homogenous freezing resulting from a swift and controlled process is only possible thanks to simultaneous freezing from both sides. This leads to an even process all the way to the core, thus preventing the core’s expansion and concurrent damages as they may result from freezing with static freezers.
Sophisticated and intelligent freezing system will have to cover three main aspects in order to meet the basic requirements of today’s biopharmaceutical industry:
These three parameters have to be considered in order for a platform to be relevant for drug substance logistics in labs and manufacturing, both for small batches and bulk production.
With RoSS.pFTU, Single Use Support has developed a freeze-thaw platform that addresses the needs of the industry and provides solutions. The system designed by Single Use Support allows for a blast-like freezing where the substance contained in RoSS® is evenly frozen thanks to the direct contact between the plate freezer and the stainless steel plates covering the container: The close contact between freezing plates and liquid substance significantly speeds up the process as it facilitates a direct transfer of the cold. Additionally, there is no ambient air that requires cooling, as is the case with traditional freezers. The homogenous outcome of this freezing process not only maintains the substance’s original quality but also protects it from potential damages during shipping and thawing.
In addition to affording fast and homogeneous results, SUSupport’s freeze-thaw platform offers additional benefits that merit its use in the biopharma and similar industries:
Intelligent freeze-thaw platforms have become an indispensable part of labs with their highly complex demands – and especially with their increased need for scalability. Single Use Support’s RoSS.pFTU lab scale is the answer to any such requirements as it offers comprehensive and user-friendly scalability:
Customers have a choice of four different sizes in order to find the right match for their respective needs. Scalability ranges from 100 ml (RoSS.pFTU lab scale) up to more than 200 l (RoSS.pFTU large scale).
When it comes to long-term cold storage, the frozen RoSS shells can be stored in RoSS.FRIG. This high density storage ultracold fridge for frozen drug substances allows great relief for cold room storage capacities due to its high storage density and stackability of RoSS shells. Moreover, RoSS.FRIG itself is stackable and flexible due to its portable use in-plant.
Based on a sophisticated end-to-end solution, Single Use Support’s plate freezer allows customers to save both time and money. If performed with traditional static freezers, the filling of single use bags including prep work and freezing takes anything between 48 and 72 hours.
With RoSS®, labs and production plants can shorten the entire process to a mere third of that time. Furthermore, it allows for a significant reduction of power and water consumption. The system does not require any elaborate cleaning or maintenance measures, which eliminates another time-consuming task. And to tie it all together, the platform offers integrated space to store the frozen substances. With RoSS.pFTU for freezing and RoSS.FRIG for storage the cold chain down to -80°C can be secured.
Thanks to a leasing model, the costs can be held at a minimum and there is no need for further validation if or whenever the customer requires an upgrade in terms of batch sizes. Put simply, the Freeze Thaw Platform developed by Single Use Support offers biopharmaceutical manufacturers and labs exciting new possibilities in terms of fill and finish and for drug substance logistics in general.
(1) Bezavada A, et al.: Use of Blast Freezers in Vaccine Manufacturing. 2011. In: Bioprocess International