Understanding how bioprocess changes impact product quality is crucial for successful biopharmaceutical development. However, frequent data collection across the entire bioprocess can be a significant challenge for analytical teams.
This webinar explores a streamlined solution for acquiring critical mAb quality attributes, including charge variant profiles, sequence identity, glycosylation profiles, and glycation levels. We will demonstrate a simple "dilute-and-shoot" analysis utilizing ZipChip capillary electrophoresis coupled with high-resolution mass spectrometry.
Furthermore, we will present a case study comparing CHO fed-batch processes with traditional daily bolus glucose feeding and a 2g/L dynamic glucose feed strategy, enabled by MAVEN monitoring and control. This study highlights the clear impact of process feeding strategies on product quality profiles.
Presenters
Erin Redman, PhD, Principal Scientist, 908 Devices
Graziella Piras, PhD, Senior Director of Strategic Marketing, Life Science, 908 Devices
Key Takeaways:
Streamline mAb product quality assessment throughout bioprocess runs.
Gain insights into charge variant profiles, sequence identity, glycosylation profiles, and glycation levels.
Understand the link between process feeding strategies and product quality.
Learn how bioprocess monitoring enables control, such as stabilizing glucose levels at 2g/L via MAVEN control to reduce glycation.
Explore the benefits of both off-line analytical and on-line process analytical technology (PAT) solutions.
Discover the efficiency of the dilute-and-shoot ZipChip-MS CVA workflow for frequent measurements.
A broad range of separation techniques are now routinely combined with mass spectrometry for in-depth biopharmaceutical characterization. Simultaneously, MS software tools have evolved to support the storage, processing, and reporting of the expanding MS data oceans. Here recent progress, challenges, and learnings from MS-based workflows of biopharmaceutical charge variants will be presented and illustrated through case-studies.
In this webinar, you will learn:
The crucial role that CE-MS plays in a biopharma development lab for the comprehensive characterization of biopharmaceuticals.
How CE-MS can be used to improve the efficiency of characterization workflows by eliminating method development and increasing the throughput while gaining deeper insights through in-depth analysis of biopharmaceuticals.
Who should attend:
Scientists working in protein characterization labs for biotherapeutics
Analytical scientists working in biopharmaceutical labs
CDMO labs looking to optimize workflows and improve efficiency
[post_title] => Charge Variant Analysis for Intact Protein Characterization in a Biopharmaceutical Development Lab – Lessons Learned and the Road Ahead
[post_excerpt] => How CE-MS can be used to improve the efficiency of characterization workflows by eliminating method development and increasing the throughput while gaining deeper insights through in-depth analysis of biopharmaceuticals.
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Improve Process Intensification
Process intensification requires a thorough understanding of the process to achieve desired yields while improving resource utilization and maintaining consistent product quality. Continuous monitoring of glucose and lactate provides deeper process understanding. Dynamic glucose control can lead to better cell viability, lower levels of lactate production, and therefore, higher titer and better control of quality attributes (CQAs) in fed-batch and intensified processes. Learn how you can make more informed decisions with in-line, on-line and at-line analytics of key process parameters
[post_title] => Data-driven Process Intensification – Utilizing Smart Analytics to Achieve your Bioprocess Goals
[post_excerpt] => This BPI presentation discusses process intensification and rapid analytics of critical parameters for cell culture, which is necessary to control the process and end product. See how fast and simple analytics significantly speed up the development and optimization processes.
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[post_title] => Rapid Clone Screening of Biosimilar Candidates Using Microfluidic CE-MS
[post_excerpt] => In this GEN webinar, our expert speakers, Erin Redman, PhD, and Ruben Cageling, will describe how the ZipChip microfluidic CE-MS technology enables rapid early-stage clone screening for biotherapeutics development. They will present a case study where the ZipChip was used to select clonal cell lines based on their charge variants and glycosylation profile. Furthermore, they will also highlight the new CVA kit, which enabled better separation and sensitivity in charge variant analysis of biotherapeutics.
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About this Webinar
Peptide mapping is considered the gold standard for the analysis of biopharmaceuticals. Classical analysis is performed through long workflows involving extensive sample handling and long liquid chromatography (LC-MS) analysis times.
The distinct advantages of short analysis times and unique separation mechanisms makes Capillary Electrophoresis (CE-MS) an attractive alternative for the peptide mapping analysis. Nevertheless, most existing sample preparation protocols are either incompatible with CE-MS analysis or require additional steps for salt removal that may increase sample handling.
Key Takeaways
An overview of the ZipChip Microchip CE-MS technology and its typical application space
How to optimize CE-MS compatible sample preparation using a total workflow length of 2 hours
Data analysis will provide full sequence coverage and accurate quantitation of product quality attributes
Wide applicability of the workflow to different IgG subclasses will be demonstrated
A panel discussion (Q&A) at the end
Microchip CE-MS technology, its capabilities, and typical application space
How CE-MS technology can enhance peptide mapping throughput
Coupling peptide mapping sample preparation of monoclonal antibodies to CE-MS analysis
CE-MS analysis provides robust determination of quality attributes in less than 15 minutes
Meet the Speakers
Sara Carillo
Dr. Sara Carillo completed her Ph.D. in Chemical Sciences in 2013 at the University of Naples “Federico II”. Under the guidance of Prof. Corsaro, she focused on the structural characterisation of polysaccharides and glyco-conjugates from Gram-negative bacteria via NMR and mass spectrometry techniques, focusing on the immunological properties and potentials of extremophiles endotoxins. After a period at the University College of Dublin, in 2015 she joined Dr. Jonathan Bones’s research group in NIBRT working on understanding of the effects of extractables and leachables from single-use bioreactors on CHO cells N-glycome and produced monoclonal antibodies. She is now working in NIBRT as Bioanalytical Research Lead and is mainly interested in the development of new analytical approaches to ensure a deeper and easier understanding of biomanufacturing processes and biopharmaceuticals’ structural complexity.
Adi Kulkarni
Adi Kulkarni is a Principal Scientist. Adi has extensive experience in applying CE-MS in biopharma characterization workflows using different mass spec platforms. He has developed novel applications based on the ZipChip technology and managing strategic collaborations and partnerships. Prior to working at 908 Devices, Adi was an applications scientist at Bruker Daltonics where he worked on Bruker’s Q-TOF line of products. He received his Ph.D. at the University of Massachusetts in 2011 where he developed novel methodologies for the synthesis of nitrogen-containing heterocycles. After his Ph.D., Adi was a postdoctoral fellow at University of Southern California’s Loker Hydrocarbon Research Institute where he discovered new reagents for applications in organofluorine chemistry. He has authored 18 peer-reviewed articles.
Jonathan Bones
Jonathan Bones is the principal investigator of the Characterisation and Comparability Laboratory at NIBRT. An analytical chemist by training, Jonathan’s research group specializes in the development and application of analytical solutions for problems associated with the manufacture and characterization of biopharmaceuticals. This includes recombinant proteins, monoclonal antibodies, and advanced therapies like AAV based gene therapy, cell therapy, and mRNA using their core excellence in analytical separations coupled to mass spectrometry.
Erin Redman
Erin Redman is a Principal Scientist in the Research and Development division of 908 Devices. She joined the company in 2016 and has worked to develop protein characterization assays using the ZipChip technology and further the innovation microfluidic CE separations coupled to mass spectrometry. Prior to starting her career at 908 Devices, she received her Ph.D. under the direction of Professor J. Michael Ramsey at the University of North Carolina at Chapel Hill. There she developed microfluidic technology for interfacing high resolution separations with electrospray mass spectrometry for the characterization of intact biotherapeutic proteins and proteins from biofluids.
[post_title] => NIBRT presents ZipChip for biopharma characterization
[post_excerpt] => In this webinar NIBRT demonstrates ZipChip's ease of use and flexibility from the control of upstream processes to downstream biotherapeutics characterisation.
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About this Webinar
Understanding how bioprocess changes impact product quality is crucial for successful biopharmaceutical development. However, frequent data collection across the entire bioprocess can be a significant challenge for analytical teams.
This webinar explores a streamlined solution for acquiring critical mAb quality attributes, including charge variant profiles, sequence identity, glycosylation profiles, and glycation levels. We will demonstrate a simple "dilute-and-shoot" analysis utilizing ZipChip capillary electrophoresis coupled with high-resolution mass spectrometry.
Furthermore, we will present a case study comparing CHO fed-batch processes with traditional daily bolus glucose feeding and a 2g/L dynamic glucose feed strategy, enabled by MAVEN monitoring and control. This study highlights the clear impact of process feeding strategies on product quality profiles.
Presenters
Erin Redman, PhD, Principal Scientist, 908 Devices
Graziella Piras, PhD, Senior Director of Strategic Marketing, Life Science, 908 Devices
Key Takeaways:
Streamline mAb product quality assessment throughout bioprocess runs.
Gain insights into charge variant profiles, sequence identity, glycosylation profiles, and glycation levels.
Understand the link between process feeding strategies and product quality.
Learn how bioprocess monitoring enables control, such as stabilizing glucose levels at 2g/L via MAVEN control to reduce glycation.
Explore the benefits of both off-line analytical and on-line process analytical technology (PAT) solutions.
Discover the efficiency of the dilute-and-shoot ZipChip-MS CVA workflow for frequent measurements.
