With bulk drug substances playing an increasingly important role in the pharmaceutical and biopharmaceutical industry, the need for a reliable freeze/thaw process as well as safe shipping and storage is more important than ever.
At Single Use Support, we have set ourselves the goal to provide the biopharmaceutical industry with solutions that support them in increasing the reliability of storage and shipping and in turn minimizing the loss of valuable high-quality drug substance.
Storage and shipping of bulk protein solution are important steps on the way from an active agent to the final end product. If those steps are carried out at a temperature above the solution’s freezing point, this can lead to detrimental shear stress as well as microbial contamination. As a consequence, freezing those agents and shipping them in a frozen state can prevent these issues.
For more detailed reading and further information, check our white paper and case study on our scalable freeze and thaw platform for pharmaceutical bulk drug substance.
However, the freezing of liquid solutions is a complex process that poses its own challenges and may lead to Cryoconcentration due to the formation of ice. In other cases – depending on the protein solution to be frozen – the process may result in the formation of aggregates followed by denaturation.
Both of these cases are less than ideal as they will invariably lead to the loss of valuable and potentially life-saving drug substance. Clearly, this dilemma calls for action and that is where Single Use Support comes in.
For our research, we performed a series of tests in which we tested the influence of various parameters on the extent of Cryoconcentration and compiled extensive data from literature. This has led to the conclusion that plate freezers – in combination with single use bags – are a predestined solution for the freezing process of protein solutions.
With this seemingly simply combination of two components – plate freezer and single use bags – the protein solution is separated from the cold surface by only a thin polyethylene layer, which ensures an optimal heat transfer from the heat transfer plates to the substance to be frozen.
Furthermore, this method offers a better heat transfer coefficient than bottles that are frozen by using cold air in blast or static freezers. But that is not the only advantage: Plate freezers also cover relatively short freezing distances as opposed to plastic bottles or Cryo vessels made of stainless steel, thus allowing for a fast freeze front velocity and better control of the temperature.
With all these factors in mind and after extensive research and trial-and-errors, we have developed a plate freezer that enables the bulk freezing and thawing of large quantities of solution.
The freezer can handle volumes of up to 300 L that are contained in 50 L single use bags and covers the entire process in less than 2 minutes.
The bags are encased in our RoSS® shells that are constructed of a plastic frame with the base and lid made of stainless steel. This combination of materials not only offers added protection but also facilitates optimal heat transfer rates during the thawing process.
We have designed our plate freezer so it allows for a scalable process, both in terms of last point of freeze and based on protein activity. With our technology we are pushing the freeze thaw technology to the next level. We offer players in the biopharmaceutical industry an advanced and reliable solution for their logistics process – a scalable platform for the a quick and reliable freeze/thaw process of bulk drug substances.