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