Assessing biotherapeutic developability using advanced mass spectrometry workflows

12 Jun 2026

This case study explores how Sanofi uses mass spectrometry (MS) workflows to assess the developability of novel biotherapeutics, focusing on identifying chemical liabilities and key attributes that influence stability, efficacy, and manufacturability. The study highlights the increasing complexity of modern biotherapeutics and the need for high-throughput, data-driven analytical approaches.

Using the Genedata Expressionist platform, Sanofi implemented configurable, automated MS data processing workflows to integrate and analyze complex datasets from multiple instruments and assays. The approach enables improved data transparency, standardization, and scalability, supporting rapid identification of modifications and structural features that may impact product quality. This enhanced analytical capability allows earlier decision-making, reduces development risk, and accelerates the optimization of next-generation therapeutic candidates.

Resource details:

  • Resource type: Case study
  • Page count: 4
  • Read time: 6 mins

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Data AnalysisData analysis hardware and software is available to make data processing straight-forward yet powerful. Data software can be used for math and stats, technical graphing and image analysis. In addition, software is available for specific data analysis of electrophoresis, densitometry, ELISA and DNA sequencing.Mass SpectrometryMass spectrometry (MS) is a powerful analytical technique used to identify and quantify molecules based on the mass-to-charge ratio of gas-phase ions. It provides detailed information about the structure, composition, and properties of compounds and is widely used across fields such as environmental monitoring, materials science, drug discovery and development, food and beverage testing, and wider chemical research. Key MS techniques include tandem mass spectrometry (MS/MS), liquid chromatography–mass spectrometry (LS-MS) and inductively coupled plasma (ICP-MS). Choosing from these wide range of techniques and technologies can be a daunting task, so keep up to date with scientific applications, performance expectations, and customer reviews here all in one place. Visit our product directory to receive quotes direct from the manufacturer. BiotherapeuticsBiotherapeutics are proteins and other compounds (such as nucleic acids) produced by living organisms that have uses as therapeutics or in in vivo diagnostics. The most well-known example of a biotherapeutic product, and the first to be approved for therapeutic use, was recombinant human insulin.Protein Characterization