As described in ICH Q6B, the process-related impurities are derived from the manufacturing and are necessary to control in all biopharmaceutical products. These are classified into three major categories:
a) Cell substrate-derived impurities: Proteins derived from the host organism, nucleic acid.
b) Cell culture-derived impurities: Inducers antibiotics, serum, and other media components.
c) Downstream-derived impurities: enzymes, chemical and biochemical processing reagents, inorganic salts, leachable.
AMSbiopharma provides analytical methodologies based on high-resolution liquid chromatography (HPLC) and gas chromatography (GC) coupled with mass spectrometry for the analysis of a wide range of these impurities at low concentrations. Our analytical solutions include:
• Cell culture impurities
◦ Antifoams
◦ Growth modifiers
◦ Antibiotics
◦ Protein A
◦ Solubilizers
◦ Residual solvents
◦ Chelating agents
◦ Extractables and leachables
• Downstream-derived impurities:
◦ Detergent
◦ Protein A
◦ Process additives
◦ Extractables and leachables
AMSbiopharma scientists have a large experience in the development of these type of methodologies, so if your biopharmaceutical may have a new or unusual impurity, in AMSbiopharma can also develop a new methodology for its analysis. Please, contact us for more information.