Speaker: Chris Pohl, Vice President, Research & Development, Chromatography Chemistry, Thermo Fisher Scientific
When: Wed, Aug 4, 2021 9:00 AM - 10:00 AM PDT
Registration link: https://register.gotowebinar.com/register/7467419398288012048
Abstract: Since the approval of the first therapeutic monoclonal antibody, muromonab-CD3, in 1986, the field of monoclonal antibody therapeutics has exploded into a variety of monoclonal antibody-based therapeutics, such as bi-specifics and antibody drug conjugates (ADCs). Unlike small molecule drugs whose production can be tightly controlled, production of biotherapeutics using biological vehicles creates its own challenges in not only producing a pure product but also a properly conformed one. The need to characterize product quality attributes continues to be of critical importance in ensuring the efficacy and safety of biotherapeutics. Since Dionex released the ProPac WCX-10 in 1998 for charge variant analysis, the team in Sunnyvale, led by Chris Pohl (VP R&D), has continued to develop new generations of columns focused on large molecule chromatography, based on feedback from the Biopharma community to address regulatory approval requirements. Charge variants, oxidation, deamidation, and drug to antibody ratios are just a few of the analysis that have become commonplace, and Thermo Fisher Scientific has led the way in offering chromatography solutions for biotherapeutics characterization, from ProPac WCX-10 to ProPac ELITE and CX-1 buffers. Join us to learn what we’ve learned from the biopharma community during the past 23 years.
Key Learning Objectives: • HPLC based techniques for characterization of monoclonal antibody-based biotherapeutics
Who Should Attend: • Method developers for UHPLC and HPLC methods supporting monoclonal antibody development • Method QC chemists who use these columns (ProPac WCX-10, ProPac ELITE, etc.) everyday
• Dr. Shengsheng Xu, Senior Scientist II, Bioanalytical Services, Frontage Laboratories, Inc.
• Dr. Ke Li, Senior Scientist I, Bioanalytical Services, Frontage Laboratories, Inc.
Registration link: https://register.gotowebinar.com/register/8388674901497093647
Date: June 30, 2021, Wed., 12:00 PM EDT
Abstract: Protein therapeutics have become more and more popular in recent years due to their high target specificity and relative low toxicity. The structural complexity of these biologics poses challenges to gold standard bioanalytical approach, as known as ligand bind assay (LBA), which is unable to detect any structural alterations happen on proteins. These potential structural changes on protein therapeutics are critical for pharmacokinetic (PK)/pharmacodynamics (PD) evaluation. On the other hand, protein biomarkers have entered into a new phase for drug discovery. The association between target protein biomarker and other endogenous proteins raises the concern for applying LBA based assay. LC-MS has emerged as a state-of-the-art technique to overcome this type of challenges in quantitation of protein therapeutics and protein biomarkers. This webinar will review the application of different LC-MS based approaches including bottom-up, top-down and middle-down. Case studies relevant to these approaches will also be presented.
Key Learning Objective:
• Bioanalytical Challenges & Approaches for protein therapeutics and biomarkers Who Should Attend:
• Bioanalytical method developers for protein therapeutics and biomarkers
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