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GEN Presents An Educational And Informative Webinar

Monitoring Product and Process Attributes in Biopharmaceutical Development and QC

  • Broadcast Date: Wednesday, Oct 19, 2016
  • Time: 11:00 am ET, 8:00 am PT
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Across biopharmaceutical development, LC-MS has been a foundational technology for the discovery and characterization of biotherapeutic attributes—including post-translational modifications such as glycosylation, oxidation, and deamidation, as well as process impurities such as host cell proteins and undesirable sequence variants. LC-MS performance improvements and dramatic advances in instrument robustness, ease-of-use, and accessibility for non-experts have now enabled biopharmaceutical organizations to deploy LC-MS for routine monitoring of multiple product and process attributes in late development, manufacturing, and QC/Lot release labs.

Two MS technologies have demonstrated the capability of filling this role: High-resolution MS (HRMS) platforms that can now be deployed within compliant-ready informatics platforms, and a novel quadrupole detection technology platform (nominal mass) that is designed to  operate with the  compliant-ready chromatography data system  (CDS)—Empower™ Software.

This webinar will explore both approaches using data from an accelerated degradation study that used a mAb sample, with the goal  of facilitating discussions of fit-for-purpose LC-MS for product and  process attribute monitoring.

Who Should Attend

  • Early development researchers looking to transfer their product knowledge to colleagues in late development organizations
  • Late development researchers looking to employ product and process attribute monitoring to advance formulations and stability programs
  • Process development scientists looking to drive process optimization and build greater process understanding in support of QbD and continuous manufacturing initiatives
  • QC analysts interested in deploying LC-MS product attribute assays to complement or replace the multitude of single attribute conventional release tests
  • CROs, CMOs, and academic labs looking to partner with the biopharmaceutical industry for product and process development

You Will Learn

  • That there are several effective approaches for utilizing LC-MS-based workflows for monitoring multiple product and process attributes, and how selecting the correct one for your specific challenges can simplify deployment and improve the likelihood of success
  • How a single, high-resolution LC-MS platform under the compliant-ready UNIFI® Scientific Information System can be utilized for product characterization in early development and then deployed to regulated late development and QC organizations for targeted monitoring of critical product and process attributes
  • How the ACQUITY® QDa® Mass Detector operates, and how this technology can be deployed in compliant environments under Empower CDS for routine attribute monitoring of peptides, peptide variants, released N-glycan profiles, and more
     

A live Q&A session will follow the presentations, offering you a chance to pose questions to our expert panelists.

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Panelists

  • Robert Birdsall, Ph.D.
  • Principal Scientist
  • Biopharmaceutical Science
  • Waters
  • Jing Fang, Ph.D.
  • Senior Scientist
  • Biopharmaceutical Science
  • Waters

Produced with support from