Evolving Role of Mass Spectrometry in Pharmaceutical Analysis Highlighted in New Review

Pharmaceutical analysis is a growing field that is increasingly becoming more complex. Because of the quality control requirements and strict regulations in place, pharmaceutical companies must be diligent during the drug development cycle, ensuring products not only meet consumer needs, but also local, state, and federal requirements (1,2).

As of late, mass spectrometry (MS) has been increasingly used in the drug development process. A recent review article published in Mass Spectrometry Reviews highlights the current and adapting role of MS in pharmaceutical analysis (1).

Team of Medical Research Scientists Collectively Working on a New Generation Experimental Drug Treatment. | Image Credit: © Elchin Abilov - stock.adobe.com

This review was compiled by Lucie Nováková and her team at Charles University in Prague, Czech Republic. In their review article, the research team explores the diverse applications of MS across the drug development cycle, contrasting its uses in small molecule pharmaceuticals versus biopharmaceuticals, and highlighting the advancements and future trends in this field (1). The review provides a detailed examination of how MS is employed differently in the analysis of small-molecule pharmaceuticals compared to biopharmaceuticals (1). MS analysis plays a bigger role in the analysis of large-molecule drugs and biopharmaceuticals, compared to small molecule drugs (1).

In small molecule pharmaceutical analysis, recent advancements in liquid chromatography–mass spectrometry (LC–MS) have focused on simplifying analytical procedures (1). Innovations include the reduction or elimination of sample preparation steps, simplified control and settings for MS devices, shortened analysis times, and the automation of analytical and data processing workflows. High-throughput methods such as ultra-high-performance liquid chromatography (UHPLC) and core-shell particle separations are becoming essential to meet the growing demand for speed and efficiency throughout the drug development cycle (1).

The authors also highlight how modern pharmaceutical analysis has evolved thanks to advances in automation. Initially designed to handle time-consuming and repetitive steps, automation has allowed researchers to handle large numbers of samples more efficiently, reducing analysis time and boosting productivity (1). Another benefit of automation is that it reduces human error and variability, leading to more precise and accurate measurements and data analyses (1). Furthermore, standardizing analytical procedures through automation ensures consistent and reproducible results across different laboratories and operators (1).

MS plays a key role in these processes. The authors suggest that ongoing development of data analysis tools in biopharmaceutical analysis MS methods is needed to fully realize the potential of MS in this space (1). Some of these data analysis tools include software for deconvolution, denoising, alignment, integration, quantitative analysis, and omics data processing. Although some work has been done to improve these tools for pharmaceutical analysis, new tools such as specific algorithms, machine learning, and artificial intelligence (AI)-based tools remain a work in progress (1). The researchers speculate that these tools should enhance high-throughput data processing, improve accuracy, and facilitate better data interpretation, ultimately contributing to the development of safer and more effective biopharmaceuticals (1).

By delineating the differences in MS applications for small molecules and biopharmaceuticals, and highlighting recent advancements and future trends, this research team offers a succinct recap of the role of MS in pharmaceutical analysis and what the future looks like in this field.

References

(1) Khalikova, M.; Jires, J.; Horacek, O.; et al. What is the Role of Current Mass Spectrometry in Pharmaceutical Analysis? Mass Spec. Rev. 2024, ASAP. DOI: 10.1002/mas.21858

(2) Doneski, L.; Dong, M. W. Pharmaceutical Regulations: An Overview for the Analytical Chemist. LCGC N. Am. 2023, 41 (6), 211–215. DOI: 10.56530/lcgc.na.ua3181v7