Developing a Robust CQA Monitoring Method via Multi-Attribute Monitoring Principles for Therapeutic Monoclonal Antibody Development, Manufacturing, and Lifecycle Management

Register free: http://www.biopharminternational.com/bp_w/bioaccord 

Event Overview:
Quality-by-design (QbD) principles outlined by FDA require a deep understanding of the biopharmaceutical product and process to ensure the desired product quality is met at the end of the development cycle. Aiming to support QbD and to gain greater understanding of complex biotherapeutics, there is a trend to move mass spectrometry (MS) into labs that are more familiar with optical methods. This has facilitated the introduction of liquid chromatography (LC)-MS-based multi- attribute monitoring (MAM) methods for the robust monitoring of critical quality attributes (CQAs) at the molecular level. 

In this webcast, learn about the development of a fast and robust CQA monitoring method based on multi-attribute monitoring principles using a compact, compliance-ready LC-MS system.  The presentation will demonstrate how the method can be easily transferred from development to manufacturing through commercial product lifecycle management.

In this webcast, you will learn about:

• Establish a high throughput, low artifact, subunit mass-based multi-attribute monitoring workflow

• Identification and monitoring product quality attributes such as N- and C-terminal heterogeneity, oxidation, glycation, aglycosylation, afucosylation, etc.

• The purposeful design and embedded technologies to overcome the anticipated deployment challenges into the manufacturing environment

Speaker: Samantha Ippoliti, Senior Scientist, Scientific Operations, Waters Corporation

Time and Date: Tuesday, Sept. 10, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

On demand available after airing until Sept. 10, 2020

Sponsor: Waters Corporation

Register free: http://www.biopharminternational.com/bp_w/bioaccord