Analytical Techniques for Identification and Quantification of Process Residuals


For biologics, there are two main categories of impurities: product-related impurities and process-related ones, which are further subdivided into up-stream process impurities, resulting from the bioreactor steps and down-stream impurities, generated during the concentration/purifications steps. To detect and quantify these varying types of impurities, spectroscropic, chromatographic, and immunological analytical methods have been developed.

In this presentation, a series of LC methods, developed to address common process impurities such as expression promoters, antibiotics, anti-foaming agents, and detergents will be discussed. As part of the discussion, the separation modalities, along with detection systems, specificity, quantification range, and LOQ/LOD of some of these LC methods will be provided.


  • Mario DiPaola, PhD, Senior Scientific Director, Protein Characterization, Charles River

Related Resources

Please see the links below for the other webinars in the series:

Developing a Comprehensive Analytical Similarity Program for Establishing Biosimilarity

New Strategies for Quality Control of Host Cell Protein Impurities