According to ICH Q6B guidelines, impurities in biological products can be classified as process-related or product-related. Process-related impurities include those that are derived from the manufacturing process (e.g., cell substrates, cell culture media components or downstream processing). Product-related impurities in the drug substance are molecular variants with properties different from those of the desired product formed during manufacture or storage.
To characterize these impurities, we offer a complete suite of analytical techniques for the isolation and characterization of process- and product-related impurities:
- Isolation and purification by LC: Reversed phase, ion exchange, size exclusion
- Identification: Mass spectrometry (ESI-Triple Quad, MALDI-TOF, Q-TOF), NMR (1D and 2D), FTIR, Raman and UV-Vis spectroscopy, N-terminal Edman sequencing, LC-MS/MS de novo sequencing, peptide mapping, disulfide bond mapping, amino acid analysis