White Paper

How Controlled Freezing Becomes Reality

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Bulk is being stored, frozen and transferred in biopharma manufacturing day in day out. As a given fact to have different production and fill & finish locations the industry requires a logistics process around the challenges associated with the detachment of production sites.

The most crucial aim is to bring the active pharmaceutical ingredient, either highly sensitive proteins, mRNA, mABs, ADCs or other biopharmaceutical structures, at highest quality possible from A to B. This is highly dependent on the process step of freezing the product and throughout the cold chain of storage and shipment of frozen BDS. When freezing it is exposed to stress where it mostly loses its protein activity.

Different approaches favoring cost-effectiveness, speed of performance, quality of freezing, suitability for cold chain temperature, robustness of packaging, etc. have led to different options for manufacturers. The urge to amplify scalable production options make conventional freezing procedures, such as cryovessels or static freezers, phasing out.

What is still perceived as an unsolved issue due to lack of real-world evidence is the possibility to control freezing leading to full scalability of frozen storage & shipment.

But how to control freezing?

The new insights from the study from Single Use Support and TU Vienna pave the way towards a freezing in a controlled and scalable environment, by controlling the ice front growth speed throughout different scales, by reaching high product homogeneity during freezing and by maintaining highest protein activity.

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