Understanding and Overcoming Separation Challenges in the Biological Drug Development Process

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Learn about how to improve your LC and LC–MS separations at all stages in the biological drug development process, including ways to develop deeper understanding of the drug product through improved reversed-phase chromatography of the protein backbone via peptide mapping, glycosylation, and intact and reduced mAb analysis. Live Tuesday, Oct. 1, 2019 at 1pm EDT | 12pm CDT | 10am PDT On demand available after airing until Oct. 1, 2019 Register free: Register free

Register free: http://www.chromatographyonline.com/lcgc_w/understanding

Event Overview:

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:

  • 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

  • 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. While not all separations involve HPLC, most do and would benefit from the unique characteristics of superficially porous particle columns. This webcast will walk through the biological drug development process, focusing on the unique separation needs of biologicals, including a conversation on intact and reduced mAb mass analysis by LC/MS. The webcast 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.

Key Learning Objectives

Where the critical areas for separations to have an impact on the analysis and characterization of biopharmaceuticals are in the development stages

How certain analytical techniques be applicable to both characterization and routine QC for biopharmaceuticals

How to enable the characterization of a biopharmaceutical product through better chromatography (benefits of improved column technology such as superficially porous particle (SPP) columns) in the workflow with examples

Speaker: Joseph L. Glajch, Ph.D., President, JLG AP Consulting LLC

Time and Date: Tuesday, Oct. 1, 2019 at 1pm EDT | 12pm CDT | 10am PDT

On demand available after airing until Oct. 1, 2020

Sponsor: Mac Mod Analytical

Register free: http://www.chromatographyonline.com/lcgc_w/understanding