Products Tested

Biopharmaceuticals

NDA Analytics has established a specialised team of scientists dedicated to the testing of biopharmaceuticals. The team has experience of testing protein products (including monoclonal antibodies and enzymes), DNA products and biologicals.

NDA Analytics can provide a full test regime for Purified Blood Products (PBP), such as Factor VIII, Factor VX and Human Serum Albumin. Review our PBP tests here.

While much of the testing of these products is customised to the specific product, examples of these specialised tests that can be provided for biopharmaceuticals are:

Purity and identity of product and degradation products by SDS-PAGE, isoelectric focusing, reverse-phase HPLC and western blot

Detection of soluble aggregates by size exclusion HPLC

Specificity of product by western blot

Antigenicity of product by ELISA

Detection of host cell protein by ELISA and western blot

Detection of host cell DNA by threshold system

Detection of insoluble aggregates by particulates assay and % transmission at 320nm

Determination of total protein by protein assays - BCA, DC, Lowry and Bradford methods

Assessment of quality by pH and appearance

Test of sterility by membrane filtration steritest

Test for endotoxins by kinetic and gel clot LAL test

Potency of product by enzyme activity assays

Characterisation of products by amino acid analysis and peptide mapping