Register and Join our on-demand BioAccord webinar series.

Part 1：Transforming High Performance LC-MS Analysis in Biopharma: From Molecular Characterization to Attribute Monitoring

There is an ongoing effort in the biopharm industry to extend the deployment of high-performance liquid chromatography/mass spectrometry (LC/MS) technologies beyond traditional product characterization into product quality attribute monitoring across development and manufacturing processes to deliver biopharmaceutical products with optimal properties. The demand for analytical platforms and workflows that can span and transfer between laboratories to generate product information that can be shared across diverse pharmaceutical organizations has never been higher.

Part 2：Improving Confidence and Productivity in Released Glycan Analysis for Biotherapeutic Development

Owing to the impact on drug efficacy and safety, glycosylation has long been recognized as a critical quality attribute that requires in-depth characterization and close monitoring throughout the product lifecycle of biotherapeutics. Glycosylation is generally assessed at a released glycan level using fluorescence (FLR) detection to overcome the challenges in structural complexity and broad concentration range. While sensitive optical detection alone often lacks the specificity needed for unequivocal glycan structural determination/assignment, orthogonal technologies, such as high-resolution mass spectrometry (HRMS), can provide additional structural information. These technologies, however, face great difficulty to deploy in process development and manufacturing environments due to instrumentation and analytical methodology complexity.

Part 3：Developing a Robust CQA Monitoring Method via Multi-Attribute Monitoring Principles for Therapeutic Monoclonal Antibody Development, Manufacturing, and Lifecycle Management

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.

Speakers

Mellisa Ly, PhD Principal Scientist, Analytical R&D Pfizer, Inc.	Scott J. Berger, PhD Sr. Manager, Biopharmaceutical Business Waters Corporation	Ximo Zhang Senior Scientist, Biopharmaceutical Scientific Operations Waters Corporation	Samantha Ippoliti Senior Scientist, Scientific Operations Waters Corporation

A Quick Look​ Webcast At How We Help Ensure that PCR Diagnostics Work for Virus Detection

Diagnosis of viral infection, including the novel coronavirus relies on accurate PCR tests, which in turn depend on good synthetic oligonucleotide primers.  In this first Quick Look webcast we explore how the quality of these primers is monitored using a simplified, compliant ready accurate mass LC-MS system.

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BioAccord LC-MS wins Frost & Sullivan Award

BioAccord LC-MS wins Frost & Sullivan Award For Global Pharmaceutical Analytical Instrumentation New Product Innovation

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Scientists’ Choice Awards Winner

BioAccord LC-MS voted by scientists as the Best New Drug Discovery and Development Product

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Resources

Evaluating BioAccord LC-MS System Performance for Deployment of a Compact, SmartMS-Enabled Biopharma Solution in Late Stage Development and QC Environment – Intact Mass Analysis

Routine Peptide Mapping Analysis using the BioAccord System

Released N-linked Glycan Analysis Using the BioAccord System