The processes involved in manufacturing a biopharmaceutical use biological and chemical systems to produce and purify the drug product. Therefore, the final active pharmaceutical ingredient (API) will often contain impurities related to these processes. It is a regulatory requirement to identify and monitor process-related impurities, and a qualitative and quantitative assessment of the components in the final drug product must be performed. Knowledge of the product-specific impurities, such as host-cell proteins (HCPs), arising from the cell system used to produce the biopharmaceutical, allows development of an appropriate and efficient manufacturing and purification process and ultimately serves to improve the quality of the final product.
BioPharmaSpec uses gas-chromatography and liquid-chromatography approaches for quantitative mass spectrometric (MS) analysis and monitoring of impurities. Chemical derivatization strategies are used where necessary in impurity or residual analysis, and heavy (cold) labelled peptides may be generated for identification and quantitation of specific peptides in HCP analysis.
This webinar will provide an overview of:
- Methods and instrumentation for quantitative MS
- Applications of quantitative MS including
- Monitoring of process related impurities such as inducers, antibiotics, and enzymes
- Approaches for HCP-MS
Watch the recorded webcast now.