The traditional cold ethanol fractionation - Cohn or Kistler and Nitschmann processes - of large plasma pools still forms the basis of most albumin purification procedures, although some manufacturers have introduced additional or alternative chromatographic procedures.
Modern human albumin solutions are typically 95-98% pure and are produced at 2 concentrations – 4.5-5% albumin and 20-25% albumin.
We test and release over 300 batches of albumin solutions each year for the EU. Testing is performed in line with current European Guidelines for Official Control Authority Batch Release (OCABR).
Our laboratory also tests additional batches for non-EU release, and carries out PKA assays under contract.
Find out more about NIBSC control testing.
Bernard FoxGraham RobertsGiles Sharp