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Manufacture Analytical Science, Biosimilars

Piecing Together Protein Analysis

sponsored by Thermo Fisher Scientific

When it comes to biosimilar development, companies must thoroughly characterize both the originator and the new candidate to demonstrate biosimilarity. Fortunately, in-depth analysis is easier than ever before…

The biopharma industry demands consistent quality and batch-to-batch comparability, which means that the in-depth characterization of a protein therapeutic and any modifications, such as glycosylation, is essential. The Christian Doppler Laboratory for Biosimilar Characterization, located at the University of Salzburg in Austria, has set out to address the challenges presented by protein analysis by seeking to develop and validate new techniques for characterizing therapeutic proteins. And to help with the mission, the laboratory looked to the expertise found at Thermo Fisher Scientific.

Contributors

Christian Huber, Professor of Chemistry for Biosciences at the University of Salzburg

“I am an analytical chemist by training and have been involved in method development for biochromatography and biological mass spectrometry for almost 25 years.”

Christian Huber, Professor of Chemistry for Biosciences at the University of Salzburg

Therese Wohlschlager, Postdoctoral Fellow in the Christian Doppler Laboratory for Biosimilar Characterization

“I am a biotechnologist by training and developed a strong interest in glycobiology and glycan analysis during my studies at BOKU Vienna and ETH Zurich.”

Therese Wohlschlager, Postdoctoral Fellow in the Christian Doppler Laboratory for Biosimilar Characterization

Julia Tevini, Master Student in the Christian Doppler Laboratory for Biosimilar Characterization

“I’ve been attending all courses offered by Christian Huber's group including bioanalytics and structural biology or systems biology, and they were able to pique my curiosity for bioanalytics –especially for chromatography and mass spectrometry.”

Julia Tevini, Master Student in the Christian Doppler Laboratory for Biosimilar Characterization

Frank Steiner, Scientific Advisor at Thermo Fisher Scientific

“My professional experience, which I can use in my role as Scientific Advisor in Thermo Fisher Scientific, stems both from academia and the scientific instruments industry.”

Frank Steiner, Scientific Advisor at Thermo Fisher Scientific

What makes protein characterization such an exciting field?

Christian Huber: What I really like in bioanalytical chemistry is the strong craft aspect of developing and employing novel analytical methods to bioanalytics. One has to combine technical, physical, and chemical knowledge with a significant amount of intuition and endurance to be able to provide new approaches of looking into the secrets of life.

Therese Wohlschlager: From an analytical point of view, I am fascinated by pushing the limits in (glyco)protein characterization on an intact level. Bottom-up characterization of proteins is well established and relatively straightforward to perform, but information on different proteoforms, such as glycosylation variants, is limited when characterization is performed at the peptide level. In contrast, intact protein analysis may reveal the existence and composition of different protein variants.

Julia Tevini: I’m overwhelmed by the fact that our working group is able to address questions or problems in the whole field of “-omics”. It’s also fascinating because we are not only addressing the technical challenges of instrumental techniques, but also dealing with biological questions.

Frank Steiner: Most of the chromatography work throughout my career was dedicated to chromatography of small molecules, where a very detailed understanding of the separation mechanisms evolved, even down to interactions at the molecular level. With proteins, we are not yet anywhere near to that understanding, but I’m very optimistic that we can make it there and this will help to significantly improve chromatographic column chemistries and methods for characterizing biopharmaceuticals.

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