Design of a Vessel to Facilitate Rapid Thawing of a Labile Protein

摘要

Human blood plasma contains severalproteins of therapeutic interest. Fromthe time of acquisition from the donoruntil separation and purification at themanufacturing site, the plasma ismaintained frozen to preserve proteinfunctionality. The first step of theseparation process requires the gentlethawing of a large pool of frozen plasma.Previous studies have shown thatminimizing the thaw time increases therecovery and potency of key proteins.Effective mixing is essential to reducethaw times; however, mixing must beachieved with low local shear rates,since key proteins are known to besensitive to shear.Effective mixing of the frozen plasmaunder conditions of low shear wasdemonstrated in a horizontal thawingvessel, thereby facilitating rapid thawingwith minimal loss of protein potency.Operation at the bench and pilot scaleshave shown the horizontal configurationcapable of an increase in throughput of20% and select protein recovery increaseof at least 35%.