… and validation of analytical methods for: Quality - CMC: Characterisation Stability studies Batch testing Safety & … peptides are at the crossroads of small molecules and proteins, requiring specific analytical packages depending …
… All the analytical results obtained for a therapeutic protein have to be correlated with the potency assay … Potency assays should follow the life of the product during characterisation, stability studies and GMP batch release …
… experience in: New Biological Entities , ADCs , mAbs , proteins New Chemical Entities , oligonucleotides , peptides … specific new analytical methods. In addition, we perform characterisation, stability, pharmacokinetic, biomarker and …
… and validation of analytical methods for: Quality - CMC: • Characterisation • Stability studies • Batch testing Safety … peptides are at the crossroads of small molecules and proteins, requiring specific analytical packages depending …
… an expert for the development of NBEs ( mAbs , ADCs , proteins ) NCEs , oligonucleotides , peptides mRNA … Validation of analytical methods as per ICH guidelines Characterisation of ADCs at intact, sub-unit and peptide …
… experience in: New Biological Entities , ADCs , mAbs , proteins New Chemical Entities , oligonucleotides , … specific new analytical methods. In addition, we perform characterisation, stability, pharmacokinetic, biomarker and …
… Mass Spectrometry (HDX-MS) is an innovative tool for the characterisation of therapeutic monoclonal antibodies. One … to assess biosimilarity or stability of therapeutic proteins, as well as for binding studies (see our epitope …