Webinar: Monitoring Product and Process Attributes in Biopharmaceutical Development and QC

Library Number:
WEBC134916414
Author(s):
Jing Fang and Robert Birdsall
Source:
Waters Corporation, GEN
Content Type:
On Demand Webinar

Presented by:         Dr. Jing Fang and Dr. Robert Birdsall, Waters Corporation

Hosted by:             Genetic Engineering & Biotechnology News

We invite you to watch our webinar titled "Webinar: Monitoring Product and Process Attributes in Biopharmaceutical Development and QC."

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.

In this webinar, our presenters Dr. Fang and Dr. Birdsall 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.

Watch the on-demand recording now.