288720 Design of a Vessel to Facilitate Rapid Thawing of a Labile Protein

Tuesday, October 30, 2012: 2:40 PM
Pennsylvania West (Westin )
Robert Large, Process Development & Technology, Grifols, Inc., Clayton, NC and Ajoy K. Velayudhan, Process Development and Technology, Grifols, Inc., Clayton, NC

Human blood plasma contains several proteins of therapeutic interest.  From the time of acquisition from the donor until separation and purification at the manufacturing site, the plasma is maintained frozen to preserve protein functionality.  The first step of the separation process requires the gentle thawing of a large pool of frozen plasma.  Previous studies have shown that minimizing the thaw time increases the recovery and potency of key proteins.  Effective mixing is essential to reduce thaw times; however, mixing must be achieved with low local shear rates, since key proteins are known to be sensitive to shear.

Effective mixing of the frozen plasma under conditions of low shear was demonstrated in a horizontal  thawing  vessel,  thereby  facilitating  rapid thawing  with minimal  loss  of protein potency.  Operation at the bench and pilot scales have shown the horizontal configuration capable of an increase in throughput of 20% and select protein recovery increase of at least 35%.

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