February 27, 2020
Case Study: Drug Substance Management with Single Use vs. Stainless Steel
With bulk drug substances playing an increasingly important role in the pharmaceutical and biopharmaceutical industry, the need for reliable as well as controlled freeze-thaw processes is becoming ever more important.
Not only fast freezing rates but also the protected and safe storage and shipping of bulk drug substances without any risk of contamination are imperative in today’s market.
This is why we have conducted a case study to compare the advantages respectively disadvantages of single-use systems and cryovessels. And while stainless steel cryovessels may seem the more logical choice due to sustainability, our study shows that single-use is at least one step ahead by all acounts.
For more detailed reading and further information, check our case study:
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, in turn minimizing the risk of contamination and the loss of valuable high-quality drug substance.
The freezing of liquid solutions is a complex process that poses its own challenges and may lead to Cryoconcentration or the formation of aggregates followed by denaturation. Both of these scenarios are less than ideal: They will invariably lead to the loss of valuable and potentially life-saving drug substance.
High quality freezing is important for a reliable cold chain process
This is where Single Use Support comes in with its platform for safe and reliable freezing and thawing for all stages of the production process – from lab to blockbuster.
By conducting extensive research and a multitude of tests, we have come to the conclusion that a combination of plate freezers and single use bags offer the ideal solution for a safe and reliable freezing process of protein solutions and bulk drug substances.
This seemingly simply combination of two components – plate freezer and single-use bags – separates the protein solution from the cold surface by only a thin polyethylene layer, thus ensuring an optimal heat transfer. It also allows for a faster freezing front velocity and improved temperature control when compared to plastic bottles or multi-use stainless-steel cryovessels.
We have developed a plate freezing solution that can handle volumes of up to 300l contained in 50l single use bags. 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.
And last but not least: With its fast freezing properties, our solution covers the entire process in less than 2 minutes. It is scalable and offers you a fully reliable and controlled freezing process of bulk drug substances.