Brand new invention to help biopharmas avoid cryoconcentration
But while problems caused by uneven freezing, or cryoconcentration, can put a dampener on a dinner party, such concerns pale into insignificance compared with the negative impact the process can have on biopharmaceutical manufacturers.
At least so says process technology firm Sartorius, which has been granted a US patent for a container and process to help biopharmas avoid cryoconcentration and a range of other potential problems during industrial freezing and thawing operations.
According to Sartorius containers used to store bulk biopharmaceutical materials in industrial freezers are often placed alongside one another to make the best use of space, which the firm says is a problem.
“Under these conditions cooling of the biopharmaceutical solution occurs at different rates depending on the exposure of each container to the surrounding cold air, and the extent to which that container is shielded by neighbouring containers.”
“This phenomenon is referred to as cyroconcentration” Sartorius’ continues in its new patent, adding that “in some cases such cyroconcentration could result in precipitation of the biopharmaceutical product, thus resulting in product loss.”
Will it ever stop?
Sartorius’ new technology is a container intended to replace commonly used storage bags that, in combination with patented storage and handling processes, are designed to prevent any material being lost during the freezing and thawing process.
“The volumetric expansion of the biopharmaceutical materials during freezing could generate excessive pressure in an over filled bag or in a pocket of occluded liquid adjoining the bag material, possibly leading to rupture or damage to the integrity of the bag.
“Similarly, thawing of bulk biopharmaceutical materials typically involved removing them from a freezer and allowing them to thaw at room temperature. Such uncontrolled thawing can also lead to product loss.”
Sartorius’ new containers get around this problem because they promote rapid thawing and allow manufacturers to control the temperature of biopharmaceutical materials during the process.
