Multiple Attribute Monitoring of Biopharmaceuticals Using Mass Detection

Library Number:
Sean McCarthy
Waters Corporation and GEN
Content Type:
On Demand Webinar
Related Products:

Presented by: Sean M. McCarthy, Ph.D., Senior Manager, Waters Corporation

This webinar was hosted live on July 9th 2015 by Genetic Engineering & Biotechnology News.
Watch on-demand

During biotherapeutic development, it is necessary to monitor properties of the therapeutic molecule and formulation that have been identified as critical quality attributes (CQAs) for product safety and efficacy. Currently, these analyses are conducted using optical detection. More recently, there is a trend among leading biopharmaceutical organizations to incorporate mass spectrometry into these routine assays, largely due to biomolecular complexity, but also as a means to assess more attributes in fewer analyses.

In particular, the industry is seeking to monitor post-translational modifications (PTMs), glycosylation profiles, and excipients with both UV and mass data by implementing multi-analyte or so-called Multi Attribute Methods (MAMs). These MAM assays are typically targeted towards monitoring downstream processes, but they are increasingly looked at as QC assays for lot release.

Incorporating MAMs into these environments requires the availability of analytical technologies that can be easily deployed and managed in GMP environments. Mass spectrometry, however, can require highly trained personnel and significant lab infrastructure – but recently this landscape has started to change. In this webinar, we will discuss the benefits of utilizing a cost-effective, compact, and user-friendly mass detector for routine monitoring of multiple biotherapeutic attributes. We will demonstrate through application examples that combing UV and mass detection delivers the orthogonal data points that can enable the direct and efficient implementation of MAM assays.

You Will Learn:

• How mass detection can provide the necessary specificity and sensitivity during routine monitoring of protein PTMs and identity testing when used as a supplement to optical workflows

• How the ACQUITY QDa Detector has been designed for use by chromatographers, its applications for biopharmaceutical monitoring, and how this technology can seamlessly be deployed in compliant-ready environments that use Empower 3 Software

• How the ACQUITY QDa Detector revolutionizes monitoring of released N-Glycan profiles when used with RapiFluor-MS, a breakthrough rapid tagging technology that provides improved fluorescence and unrivaled MS detection while simplifying and shortening glycan sample preparation

• Where user-friendly mass detection technology can play a role beyond peptide and glycan applications. Hear recent case study examples where the ACQUITY QDa Detector has been employed for the analysis of oligonucleotides, and for common excipients used in the formulation of biotherapeutics

Who Should Attend:

• Biopharmaceutical Development Scientists

• Biopharmaceutical Lab Mangers responsible for technology adoption and lab efficiency programs

• QC/QA Analysts

• Analytical scientists interested in glycan and peptide analysis