Transplant Centers Report Dextran Shortage

Issued: July 19, 2021

Transplant centers are reporting a shortage of Dextran-40 in normal saline for use in thawing, diluting, and/or washing cord blood units in preparation for infusion, and that current inventories have expired.

Hospira, a Pfizer subsidiary that is the principal supplier of Dextran-40 in 0.9% NaCl, says that the shortage is due to manufacturing delays and that product is not expected to be available until April next year or later.

A supplier of Dextran-40 in a powder form is Pharmacosmos. Use of this powder requires compounding on site. BioLife Solutions, Inc., manufactures an identical formulation of Dextran-40 in NaCl, or in dextrose, under GMP and has product available. The BioLife Solutions product, Cell Thawing Media, can be qualified as a raw material within a cell manufacturing or processing system, as it is not marketed as a drug product with label claims to plasma volume expander use such as those associated with the 10% Dextran-40 LMD drug products.

Thawing into Dextran-40 is the best way to preserve viability of cord blood cells. Transplant centers are strongly encouraged to qualify a substitute form of Dextran-40 to enable ongoing use of cord blood units as donors for transplantation.

When a similar shortage occurred in 2015, several banking and transplant groups developed recommendations for alternative solutions and conducted validation studies. Three of their publications are referenced below.

• How we handled the dextran shortage: an alternative washing or dilution solution for cord blood infusions. Reich-Slotky R et al., Transfusion. 2015 Jun;55(6):1147-53.
• An alternative to dextran for the thawing of cord blood units. Cloutier M et al., Transfusion. 2016 Jul;56(7):1786-91.
• How transplant centers deal with the dextran shortage: recommendations for comparing alternatives. Brady C et al., Transfusion. 2016 Nov;56(11):2657-2661.