Keeping up with New Emerging Analytical Technology

Learn about the capillary electrophoresis-mass spectrometry (CE-MS)-based Amino Acid Analyzer, a device with simple procedures that provide similar ability to the traditional LC-MS to specifically identify and quantitate an array of amino acids and several other important metabolites while providing a user-friendly interface and process.

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Event Overview:

Liquid chromatography-mass spectrometry (LC-MS) is used in various applications across the biotherapeutic protein manufacturing workflow pertaining to drug product quality. Mass spectrometry-based applications range from evaluating glycan distributions in monoclonal antibody products to optimization of the cell culture process development by monitoring amino acid and metabolite consumption. Given its analytical flexibility, LC-MS has the capacity to address complex questions; however, LC-MS instrumentation requires a high level of technical experience and more method development than other analytical procedures. Additionally, media development and feed studies in cell culture process optimization is labor-intensive and time consuming. There is a growing interest to implement efficient and simplified methods for cell culture media analysis to push for faster innovative processes in biomanufacturing. Newer analytical equipment does not attempt to address the complexity of LC-MS applications specifically targeted for high throughput media analysis of cell culture. This capillary electrophoresis-mass spectrometry (CE-MS)-based Amino Acid Analyzer is a device with simple procedures that provide similar ability to the traditional LC-MS to specifically identify and quantitate an array of amino acids and several other important metabolites while providing a user-friendly interface and process.

Key Learning Objectives:

• Ascertain the capabilities and limitations of the Amino Acid Analyzer.
• Compare the Amino Acid Analyzer, a new generation of CE-MS analytical platform, against traditional LC-MS methods.
• Evaluate the data quality, trade-offs in operation, and resourcefulness of the analytical platforms.

Speakers:

Nicole Azer, MEng
Scientist
IIFDA | CDER | OPQ | OPQR | DPQRVI

Nicole Azer, MEng, received her master's in biopharmaceutical engineering at Keck Graduate Institute and began working with the US Food and Drug Administration (FDA) in the Office of Biotechnology Products in 2019 as an Oak Ridge Institute of Science and Education fellow. Since then, she has been working with the Bioprocessing Lab in the FDA's Office of Pharmaceutical Quality Research (OPQR) to explore process analytical technology, evaluate process changes, and understand potential product quality impacts in mammalian expression systems. Her technical experience encompasses the biomanufacturing platform from cell culture through purification and chromatography, as well as analytical characterization by mass spectrometry. Recently, her work has focused on cell culture changes and amino acid quantification method development to enable feed studies that can ultimately be used to study process impacts on product quality, specifically N-glycan shifts in product monoclonal antibodies. The OPQR Bioprocessing Lab is an early adopter of emerging analytical technology and continues to investigate these novel technology advances in both manufacturing implementation and user experience.

Disclaimers
This presentation reflects the views of the author and should not be construed to represent FDA’s views or policies.
Certain commercial equipment, instruments, or materials are identified in this presentation to foster understanding. Such identification does not imply recommendation or endorsement by FDA, nor does it imply that the materials or equipment identified are necessarily the best available for the purpose.
The authors declare no competing financial interest.

Graziella Piras, Ph.D.
Sr. Director Strategic Marketing, Life Sciences
908 Devices

Graziella Piras, Ph.D. leads the strategic marketing activities for the Life Science division at 908 Devices. She has over 18 years of experience developing applications and solutions for upstream bioprocessing. Graziella previously held various R&D and marketing positions at Thermo Fisher Scientific, where she led projects to support the Cell Culture and Cell Therapy business. Graziella received her PhD in Biochemistry & Molecular Biology from the University of Liège in Belgium. She did her postdoc studying the role of gene expression and epigenetic regulation on cancer and development at the National Cancer Institutes in Maryland.


Register Free: https://www.biopharminternational.com/bp_w/emerging-analytical-technology