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


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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.

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: 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: 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: Identification of IgG2 Disulfide Isoforms by Non-Reduced Peptide Mapping Workflow

About Genedata

Genedata transforms data into intelligence with innovative software solutions that incorporate extensive biopharma R&D domain knowledge. Multinational biopharmaceutical organizations and cutting-edge biotechs around the globe rely on Genedata to digitalize and automate data-rich and complex R&D processes. From early discovery all the way to the clinic, Genedata solutions help maximize the ROI in R&D expenditure. Founded in 1997, Genedata is headquartered in Basel, Switzerland with additional offices in Boston, London, Munich, San Francisco, Singapore, and Tokyo.

http://www.genedata.com

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Helena Magloire

Genedata

Public Relations

pr@genedata.com

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