Fast and Informative Methods for Future Adaptation in Biopharmaceutical Analysis from Research to Manufacturing Laboratories

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Guest Editor

Zoja Soloviev

University College London/Sanofi

In her career Dr. Soloviev has investigated structure-function relationship of macromolecules, focusing on the in-depth protein analysis using advanced techniques such as intact and native Mass Spectrometry (MS), tandem LC-MS/MS, analytical chromatography, and bioassays. She has advanced biochemistry skills from protein expression to purification and protein analysis. Dr. Soloviev has worked in early R&D and has pioneered single molecules methods such as native MS and mass photometry in biopharma. She has a strong passion in strategic deployment to bringing fast, yet informative analytical methods to biopharma helping expedite drug pathway from molecule to the market without compromising on data quality and safety profile. Dr. Soloviev holds a BSc degree from Imperial College London, a PhD degree from the University College London and an MBA degree from the Open University. She has worked across academia, biopharma R&D and manufacturing gaining an acute understanding of the challenges faced in adopting and implementing new analytical methods. At present, she is working as a Senior Scientist at Sanofi.

Collection Overview

With the growing importance of the biopharmaceutical drugs including such modalities as vaccines, enzymes, peptides and antibodies, there is an increased need for faster, higher throughput yet also more informative analyses that could contribute to the understanding of macromolecules’ homogeneity, behaviour, structure, function, CQAs, stability and storage conditions. As demonstrated by the recent pandemic, the timelines for new drug from the molecule to the market are constantly challenged, and there is a strong need in addressing the timeline bottleneck and adapting novel and original methods for studying proteins and other macromolecules.

The aim of this Methods Collection is to explore available methods that could be used to expedite timelines, which could include single molecule analysis aiming to better understand molecules in early research, high-throughput and automation methods aiming at simplifying screening during pharmaceutical development as well as fast and low-to-zero sample consumption methods aiming at not only expediting timelines, but also challenging a more sustainable way of resource and reagent use.