Human albumin solutions

Human albumin solutions were originally developed as a blood substitute for military casualties and are now more commonly used as a colloid replacement therapy for hypovolaemia, burns, and hypoalbuminaemia. 

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.

What we do

Control 

We test and release batches of albumin solutions. Testing is performed in line with current UK Guidelines for Independent Control Testing.

Tests on each batch of final product include:

• protocol review
• assay for prekallikrein activator (PKA)
• size-exclusion high performance liquid chromatography (SE-HPLC) for polymers and aggregates
• inspection for visible particles 

Our laboratory also tests additional batches for non-UK release, and carries out PKA assays under contract. 

Find out more about NIBSC control testing.