Innovative Solutions for Digitalizing Mass Spectrometry-Based Bioanalytics Showcased at Genedata Expressionist User Group Meeting

Scientific leaders in the analytics of protein-, mRNA-, and DNA-based biotherapeutics shared how they have implemented Genedata Expressionist to automate complex analysis workflows in a variety of key and emerging domains, such as cell and gene therapy

September 15, 2021
Basel, Switzerland

Genedata, the leading provider of enterprise software solutions for biopharmaceutical R&D, today announced the successful conclusion of its inaugural annual Genedata Expressionist User Group Meeting, held on September 13–14, 2021. During this two-day virtual event attended by more than 150 Genedata users worldwide, scientific experts from leading biopharma companies presented case studies on how Genedata Expressionist is used to streamline and automate complex mass spectrometry (MS)-based data analytical processes.

The overarching theme of the event was the digitalization of biopharma MS data workflows, from early-stage characterization to downstream quality control of biopharmaceuticals. During the meeting, Genedata Expressionist users described how using automated data analysis workflows to perform in-depth characterization of novel biotherapeutics delivers significant increases in project throughput and data quality.

Case studies detailing Multi-attribute Method (MAM) implementations across organizations demonstrated the increasing assimilation of this transformative approach, which delivers increased efficiency and productivity in the development of novel biotherapeutics. Since the emergence of MAM, Genedata has worked with many biopharmaceutical companies in establishing highly automated end-to-end MAM workflows from development to manufacturing.

An entire session was dedicated to the role of MS-based analysis in the development of cell and gene therapies, with Genedata partners showcasing characterization of adeno-associated virus (AAV) capsid proteins and automated analysis of oligonucleotide therapeutics.

A keynote presentation by John Schiel, Ph.D., from NIST drew together all these strands by describing how multi-attribute method approaches are making mass spectrometry a disruptive technology for the characterization of emerging biotherapeutic modalities employed in cell and gene therapies.

“We are delighted about the rapidly growing adoption of Genedata Expressionist for digitalizing complex mass-spectrometry based analytical processes.” said Othmar Pfannes, Ph.D., CEO of Genedata. “We are committed to supporting biopharma in scaling up and automating their R&D workflows. Bringing together industry leaders and learning from them about their daily operational challenges helps us to establish best practices and drive innovation in this highly exciting field.”

Editorial Note: The following topics were presented by the organizations attending the Genedata Expressionist User Meeting

Multi-attribute method approaches to biopharmaceutical characterization and monitoring session
National Institute of Standards and Technology (NIST): Mass Spectrometry as a Disruptive Technology for Emerging Biotherapeutic Modalities
Merck Group: Validation of LC–MS Multi-Attribute Method Supporting Biopharma Process Characterization

Automation and digitalization session
Novartis: Automation of MS Analytics for Characterization of Biotherapeutics
Merck & Co.: High-Throughput Intact Mass Analysis Using Parameterization

Cell and gene therapy applications session
Biogen: Identification and Characterization of Adeno-Associated Virus Capsid Proteins by Mass Spectrometry
Roche: Semi-Automated Analysis of Oligonucleotide UV-LCMS Data for Process Development
Bayer: Software for Quality Control of Oligonucleotides by Mass Spectrometry

In-depth characterization of novel biopharmaceuticals session
Sanofi: High-Throughput and Format-Agnostic Mispairing Assay for Multispecific Antibodies Using Intact Mass Spectrometry
Merck & Co.: Identification of IgG2 Disulfide Isoforms by Non-Reduced Peptide Mapping Workflow