Interchim cover the major part of Biodrugs manufacturing process : from early research stages to development, production (cell culture production / in vitro protein expression) and purification of Recombinant proteins, Vaccines or Therapeutic antibodies...
can affect final product quality, stability, efficacy but also patient safety!
This is why the detection of these impurities is a Critical Quality Attribute (CQA) for risk managment and has to be assessed prior to batch release. The most popular method to achieve a sensitive detection is Immunoassays, started with ELISA kits (enzyme-linked immunosorbent assay) listed hereunder.