Abstract
The landscape for new biological drug development continues to evolve in complexity. With biosimilars entering the market and originator products coming off patent, the competitive race for market dominance is reliant on:
1. A deeper understanding of the drug product to produce a more comprehensive drug filing in order to delay or prevent market entrance by a competitor.
2. A more thorough characterization of an innovator product or proposed biosimilar in order to take full advantage of the Regulatory pathways to rapid approval
Pharmaceutical companies employ many orthogonal techniques and methodologies to better develop a complete picture of biopharmaceuticals which are inherently more complex than small molecules. The use of various separation technologies in the analysis of biological drugs is pervasive in the overall new product development. While not all separations involve HPLC, most do and would benefit from the unique characteristics of superficially porous particle columns. This webinar will walk through the biological drug development process, while focusing on the unique separation needs of biologicals, including a conversation on intact and reduced mAb mass analysis by LC/MS. The webinar will also demonstrate a way to develop an understanding of the protein backbone via peptide mapping and glycosylation while emphasizing areas in the workflow where superficially porous particle columns with appropriate pore sizes offer a unique advantage.