Medicines that are produced using biotechnological methods must satisfy in Europe the “DNA-recombination technology manufactured products” monograph of the European pharmacopoeia. Analysis methods for the identification, quantification and characterisation of biomolecules are clearly different to those used in the classical analysis of relatively small organic compounds. This has led to the development of a distinct branch in analysis, bioanalysis.
As an FDA-approved and GMP-certified contract laboratory in Switzerland, UFAG LABORATORIEN has established bioanalytical methods for proteins. Our portfolio comprises electrophoretic methods such as SDS-PAGE, IEF and 2D-combinations of these, blotting techniques (western blot) and amino acid composition determination, among other techniques.
Would you like to know whether these methods of analysis are suitable for your products?