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.