Jump to content

Customer Talks

A selection of conference presentations in which our customers described how they are increasing productivity and streamlining their MS-based analytical processes with Genedata Expressonist®.

Merck Group

Achieving High-Throughput HCP Analysis for Industrial Enzyme Manufacturing​​
Anders Giessing, Novozymes, Denmark

Presented at ASMS 2022

This presentation described a High-Throughput Host Cell Protein Analysis workflow build to support an industrial protein MS core facility. Analytical and data analysis solutions are combined to meet a demand to handle high sample and sequence complexity. The workflow is based on an Evosep-timsTOF Pro LC-MS/MS setup combined with a customized, fully automated Genedata Expressionist data analysis platform.​​

Merck Group

Complete Characterization of N-Linked and O-Linked Glycosylation Sites on Etanercept
Xuezhi Bi, A*STAR, Singapore

Presented at ASMS 2022

This talk described the comprehensive characterization of the heavily glycosylated Fc-fusion protein Etanercept. Acquiring mass spectrometry data using the ZenoTOF 7600 system and the novel electron activated dissociation (EAD) MS/MS mode and a "waterfall" search method in Genedata Expressionist enabled fast, high-confidence identification of multiply-glycosylated peptides.

Merck Group

Top-down Mass Spectrometry: A Very Promising Tool to Follow Biopharmaceuticals and Their Biotransformation Products in Plasma

Jonathan Dhenin, Sanofi, France

Presented at IMSC 2022

This talk addressed the challenges of diversity of modalities, low concentrations and sample amounts, and the co-existence of intact and degraded forms in bottom-up proteomic studies of in vivo biotransformation products. Dr Dhenin described how his group used Genedata Expressionist to efficiently process data from intact and middle-down LC-MS analyses of immuno-enriched plasma samples.

Merck Group

Development of Automated Workflows for Analysis and Reporting of Product-Specific Peptide Mapping Data​
Michael Pettit, Janssen, USA

Presented at CASSS-MS 2022

This talk presented the development and application of automated workflows for analysis and reporting of peptide mapping data. Customized plug-in applications for automated analysis and reporting were developed for two targeted PTM monitoring workflows. The performance of automated peptide mapping analysis and reporting was benchmarked for accuracy and processing speed against results obtained using the traditional manual approach. Additionally, the use of customized plug-ins for system and sample suitability testing was discussed.

Merck Group

Semi-automated Analysis of Oligonucleotide HPLC-UV/MS Data for Chemical Process Development Using Genedata Expressionist
Tim Nagel, F. Hoffmann-La Roche, Switzerland

Presented at TIDES USA 2022

This presentation described how automated mass spectrometry data workflows streamline the analysis of therapeutic oligonucleotides for chemical process development. These workflows enable Dr Nagel's group to analyze more samples in shorter time with less effort for the analyst, effectively debottlenecking their process research.

Merck Group

Validation of an LC-MS Multi-Attribute Method (MAM) Supporting Biopharma Process Characterization
Cédric Mesmin and Lucie Manache-Alberici, Merck Group, France

Presented at CASSS Mass Spec 2021

This presentation described Multi-attribute method (MAM) approaches to characterizing and monitoring the production of biopharmaceuticals that offer the ability to replace multiple analytical technologies with a single mass spectrometry (MS) analysis. Assessing multiple critical quality attributes (CQAs) at the molecular level delivers a comprehensive understanding of the end product; ultimately enabling a true quality-by-design approach to biotherapeutic development.

Merck Group

Product Structural Characterization for AAV-Based Gene Therapy Development
Yi Pu, Ph.D., Biogen, USA

Presented at CASSS Mass Spec 2021

This presentation addressed the challenges of mass spectrometry analysis in gene therapy and described AAV serotype identification and PTM characterization by peptide mapping.

Novartis AG

Applying LC-MS MAM during QbD-Based Development of an Antibody
Patrick S. Merkle, Ph.D., Novartis Pharma AG, Switzerland

Presented at the PEGS Virtual Summer Symposium 2021

Dr. Merkle described a peptide mapping-based Multi-Attribute Method (MAM) approach that allows for end-to-end collection of unique and high-quality data during the Quality by Design-Based development of new biological entities. His presentation highlighted Novartis' vision for LC-MS MAM as a key technology for the risk assessment of product quality attributes and summarized recent technical as well as project-related accomplishments with this approach.

Novartis AG

Automation of Analytics for Characterization of Biotherapeutics
Christian Hug, Ph.D., Novartis Pharma AG, Switzerland

Presented at the Festival of Biologics — European Antibody Congress 2020

Dr. Hug described the design and implementation of an automated infrastructure and workflows for high-throughput MS-based protein analytics at Novartis and explained how automation delivers higher productivity, harmonized data analysis, and significant time-savings.


Automated Multi Attribute Method Analyses for Process Development of mAbs
Noreen Rippolz, Ph.D., Sanofi, Germany

Presented at the Festival of Biologics — European Antibody Congress 2020

Dr. Rippolz described how her group achieves efficient PTM monitoring — through automation of sample preparation, LC-MS, and data treatment — to make MAM a powerful tool to support upstream and downstream process development and cell line development at Sanofi.


Orthogonal Advanced Mass Spectrometry Approaches for the Characterization of Biopharmaceuticals
Lucia Colarusso, Ph.D., Merck, Italy

Presented at the Festival of Biologics — European Antibody Congress 2020

Dr. Colarusso described how mass spectrometry is a key technique to disentangle the complexity of biotherapeutics and presented real-life examples of how extensive MS-based characterization of biotherapeutics is essential for building molecular knowledge and supporting product and process development.

Software Implementation for Quality Control of Oligonucleotides by Mass Spectrometry
Juliet Padden, Ph.D., Bayer Pharmaceuticals, Germany

Presented at TIDES: Oligonucleotide and Peptide Therapeutics Virtual, September 2020

Dr. Padden presented her work using mass spectrometry in quality control of oligonucleotides. She described how her group overcame the traditional data evaluation pain points of time-consuming manual steps and data-integrity gaps by implementing a dedicated Genedata Expressionist workflow that provided a high degree of automation in a fully GMP-compliant manner while enabling a deep insight into their data.


In-Depth Peptide Mapping Profiling of Multispecific Antibodies Using Genedata Expressionist
Soraya Hölper, Ph.D., Sanofi, Germany

Presented at PEGS Boston Virtual 2020

Dr. Hölper described her work using peptide mapping to perform deep characterization of innovative multispecific biotherapeutics. She also described how her group developed a custom data processing workflow that enables them to extract the maximum amount of molecular information from their biotherapeutic candidate molecules and how they created a knowledge base that allows them to leverage the insights gained throughout a molecule’s lifecycle for future analyses and development.


Development of Automated Mass Spectrometry Data Evaluation Workflows for Analysis of Therapeutic Proteins
Francis Bitsch, Ph.D., Novartis Pharma AG, Switzerland  

Presented at the 2020 annual meeting of the Association of Biomolecular Resource Facilities (ABRF)

Dr. Bitsch described how Novartis have developed an IT environment and a series of workflows using Genedata Expressionist to automatically process, interpret, and report protein mass spectrometry data generated on different MS platforms located in various locations of their research organization. The approach enables reduction of data volume and CPU-intense processing and allows 24/7 processing of data. CQAs such as identity, integrity, and PTM modifications are determined and automatically reported using template reports. Dr. Bitsch presented strategies for bispecific antibody MS characterization and provided a set of examples describing automated determination of molecular mass and assessment of chain pairing.


Automated Multi Attribute Method Analyses for Process Development and Characterization of mAbs
Martin Hoffmann, Ph.D., Sanofi, Germany

Presented at the 2019 PEGS Europe Protein & Antibody Engineering Summit in Lisbon, Portugal

Dr. Hoffmann presented a mass spectrometry based  multi-attribute method (MAM) approach to simultaneously monitor critical quality attributes (CQA) and support process development of therapeutic monoclonal antibodies (mAbs). For CQA quantification, mAb samples were digested on an automated liquid handling robot and analyzed by HPLC separation in combination with high-resolution mass spectrometric detection. Focus of the presentation was automated MS data analysis using Genedata Expressionist software.


A Reliable and Automated Workflow for LC-MS MAM Analysis of Biopharmaceuticals—From High Throughput Sample Preparation to Data Evaluation
Patrick Sascha Merkle, Ph.D., Novartis Pharma AG, Switzerland  

Presented at the 2019 PEGS Europe Protein & Antibody Engineering Summit in Lisbon, Portugal

Dr. Merkle described how the LC-MS multi-attribute method (MAM) has emerged as a promising approach for the characterization and relative quantification of critical quality attributes on biopharmaceutical molecules. He presented a peptide-level LC-MS MAM workflow that relies on high-throughput sample preparation, high-resolution MS acquisition, and automated data evaluation using Genedata Expressionist software. He also explained how he envisaged that the simplicity and state of automation of the presented LC-MS MAM workflow would allow its routine use in a non-expert laboratory.


QbD-based selection of analytical methods for development and characterization of a biotherapeutic
Christoph Rösli, Ph.D., Novartis Pharma AG, Switzerland

Presented at the 2019 Advanced Analytical Technologies for Protein (AATP) Meeting, Paris, France.

In his keynote lecture, Christoph Rösli of the Late Phase Analytical Development department at Novartis, described how Genedata Expressionist provides a single, scalable, enterprise software platform for MAM implementations.


A single software platform providing automated MS data processing for end-to-end MAM lifecycle management
Alexander Veach, Amgen, USA

Presented at the 16th Symposium on the Practical Applications of Mass Spectrometry in the Biotechnology Industry 2019 in Chicago, IL, USA.

Alexander Veach, a Process Development Associate Scientist at Amgen, described how he obtains improved data accuracy and significant time-savings using Genedata Expressionist as an automated, single-software data-processing platform throughout a multi-attribute method (MAM) lifecycle.


Coupled Native Mass Spectrometry (CV-MS): Developing Rapid and Automated Workflows for Regulated Environments
Mauro Sassi, Ph.D., Merck Serono, Italy

Presented at the 2019 ASMS Conference on Mass Spectrometry and Allied Topics in Atlanta, GA, USA.

Dr. Sassi presented automated Genedata Expressionist application-specific data processing workflows that provide rapid and reliable methods for targeted and automated MS-based charge variant analysis of biotherapeutics.


MS-Based Characterization of Biotherapeutics and Host Cell Proteins in Production Bioprocesses Using a Single Software Platform
Xiaojuan Li, Ph.D., Associate Principal Scientist, Merck, Kenilworth, NJ, USA 

Presented at PEGS: The Essential Protein Engineering Summit 2019 in Boston, MA, USA.

In this Lunch & Learn presentation, Dr. Li talked about how she uses Genedata Expressionist not only for efficiently characterizing biotherapeutic products, but also for detecting and quantifying host cell protein impurities during their manufacture through bioprocess monitoring.


Assessment of the Risk/Benefit of Applying Mass Spectrometric Techniques at Different Stages of Biotherapeutic Development
Jennifer Nemeth, Ph.D., Director, Biophysics-Structural Characterization, Janssen, Philadelphia, PA, USA 

Presented at PEGS: The Essential Protein Engineering Summit 2019 in Boston, MA, USA.

New biologic drug development is costly, and where money is spent impacts a company’s pipeline. Upfront spend can allow for quicker Go/NoGo decisions or while limited development allows for a faster path to PoC. Dr Nemeth's talk focused on the benefits/risks of applying MS-based analytical assays before vs after New Molecular Entity Declaration, and which assays were found to be the most impactful for selection to justify the spend and time.


Glycosylation Profiling of Biopharmaceuticals Using Cutting-edge Mass Spectrometry Techniques and an Advanced Data Processing Platform
Lucio Manzi, Ph.D., Associate Researcher – Structural Characterization Lab, Protein Chemistry Department, Merck Group 

Presented at CASSS Analytical Technologies Europe 2019 in Dublin, Ireland.

Dr. Manzi presented results obtained using cutting-edge MS techniques and demonstrated how analysis at all three levels — protein, peptide, and glycan — can be combined to provide a comprehensive characterization of glycosylation in biopharmaceuticals. He also explained how this characterization is significantly facilitated and streamlined by using the Genedata Expressionist enterprise mass spectrometry software platform, which provides the flexibility required to adapt to any MS-based analytical approach and offers intelligent automated data workflows for routine MS-based monitoring.


Automating Data Analysis for the Characterization of Biotherapeutics Candidates
Daniela Tomazela, PhD, Associate Principal Scientist, Biology-Discovery, Mass Spectrometry, Merck, Kenilworth, NJ, USA 

Presented at the 10th Annual Biotherapeutics Analytical Summit 2019 in Alexandria, VA, USA.

As part of discovery-developability, sequence-variant evaluation and analysis of stressed samples are critical steps on the path toward final candidate selection. The diverse and large volumes of data generated during the evaluation of molecules’ intactness, sequence coverage, and potential liabilities makes producing reports cumbersome and time-consuming. In this talk, Dr. Tomazela focused on MS analysis of biotherapeutic candidates to demonstrate an implementation of data analysis automation in support of early-discovery.


Characterization of Complex Glycosylation Patterns for Biopharmaceuticals
Urs Lohrig, Ph.D., Labhead AL1, Novartis - Global Drug Development / Technical Research & Development, Sandoz GmbH, Austria

Presented at the 2018 PEGS Europe Protein & Antibody Engineering Summit in Lisbon, Portugal.

Glycosylation remains a major challenge when probing the molecular structure of biopharmaceuticals. Tools for the in-depth characterization of N- and O-glycosylations have been developed over the years and have been employed on various levels within the industry. Dr. Lohrig presented approaches including hyphenated LC-MS/MS on various levels to tackle the complexity of glycan modifications within biosimilar characterization workflows. This enables a suitable depth of knowledge for manufacturing process development as well as supporting final biosimilarity evaluation.


Identification and Quantitation of Duobody® Bispecific IgG1 Using Mass Spectrometry and Automated Data Processing and Analysis Workflow
Ewald van den Bremer, Ph.D., Senior Scientist, Analytical Sciences, Genmab B.V. , The Netherlands

Presented at the 2018 PEGS Europe Protein & Antibody Engineering Summit in Lisbon, Portugal

The characterization of bispecific antibodies (BsAbs) by mass spectrometry (MS) offers several advantages over traditional chromatographic techniques (e.g. HIC, CEX). MS provides unambiguous identification and relevant quantitative information, and combined with automated data processing and analysis, it can be employed in a high-throughput environment. Dr. van den Bremer presented the Genedata  Expressionist software platform and the related workflows that enabled his lab to  accelerate BsAb research batch characterization and release, while at the same time, achieving high quality results and significant time and cost savings.

Just Biotherapeutics

Interlaboratory Performance Metrics from the MAM Consortium New Peak Detection Round Robin Study
Richard Rogers, PhD, Principal Scientist, Just Biotherapeutics, USA 

Presented at the 2018 Bioanalytical and Formulation Summit in Dublin, Ireland

Dr. Rogers presented the results of the Multi-Attribute Method (MAM) consortium new peak detection round robin study that aimed to evaluate interlaboratory reproducibility of MAM, understand qualitative and quantitative capabilities of the platform, establish performance metrics, and assess the state-of-the-industry regarding MAM.

Novo Nordisk

Automated Analysis of MS Data from a Diverse Biomolecular Portfolio
Jasmin Sydow-Andersen, Ph.D., Senior Scientist, Novo Nordisk A/S, Denmark 

Presented at the 2018 Symposium on the Practical Applications of Mass Spectrometry in the Biotechnology Industry in San Francisco, CA, USA

Dr. Sydow-Andersen described how her group analyzes LC-MS/MS data sets from a wide range of molecules — from small peptides to large protein complexes. This portfolio of different proteins represents a significant analytical challenge, as they all potentially carry different kinds of modifications, which in turn require specific MS methods that use different instruments. She also explained how Genedata Expressionist — which not only automates data processing using a workflow-based approach, but also supports a wide variety of data sources and allows implementation of any MS application or method — addresses this and other challenges.


Identification of Multiple Serine to Asparagine Sequence Variation Sites in an Intended Copy Product Of LUCENTIS® by Mass Spectrometry
François Griaud, Ph.D., Principal Scientist, Novartis Pharma AG, Basel, Switzerland 

Presented at the 2018 Symposium on the Practical Applications of Mass Spectrometry in the Biotechnology Industry in San Francisco, CA, USA

Dr. Griaud described how his group used Genedata Expressionist for intact and subunit mass analysis of a Fab and also to confirm the presence of a serine to asparagine sequence variant in the light chain of an intended copy product through peptide mapping.


MAM for Developability Assessment of Biopharmaceutical Candidates
Holly Yip, Ph.D., Sr. Research Associate, Genentech, USA 

Presented at the 2018 Symposium on the Practical Applications of Mass Spectrometry in the Biotechnology Industry in San Francisco, CA, USA

Dr. Yip described how her group used Genedata Expressionist and a rapid and robust automated MS data analysis workflow to identify and quantitate post-translational modifications during developability assessment of molecules before they enter early development. This assessment enables early selection of candidate molecules with suitable physicochemical properties and manufacturability profiles, and ultimately, increases the chances of creating a successful drug.

Weizmann Institute of Science

Quantitative Analysis of Free Circulating Light Chains Using a Novel Time-Resolved Deconvolution Approach for Reliable Comparison of a Clinical Sample Cohort on the Tribrid Orbitrap Fusion Lumos
Yishai Levin, Ph.D., Head, de Botton Institute for Protein Profiling, The Nancy and Stephen Grand Israel National Center for Personalized Medicine, Weizmann Institute of Science, Israel  

Presented at the 9th Annual Biotherapeutics Analytical Summit in Baltimore, USA

Dr. Levin described how his group used the proprietary Genedata Expressionist time-resolved deconvolution approach to analyze free-circulating antibody light chains in clinical samples.

Find Out More About Genedata Expressionist

Contact Us