Bioanalysis is a critical part of drug development. From drug discovery, through to pre-clinical and clinical studies, understanding drug exposure, safety, and metabolism are essential in accelerating drugs to clinic and commercialization.
ICP-MS bioanalysis and elemental bioanalysis enable the sensitive quantification of metals, elemental biomarkers and metal-containing therapeutics, providing critical data to support ADME, toxicology and clinical development programmes. In this Q&A, Polly Foreman, Head of Bioanalytical Services at Arcinova, discusses ICP-MS applications, LC-ICP-MS analysis, elemental biomarker studies and how bioanalytical services support drug development programmes.
What is Your Background and Your Current Role?
I joined Arcinova nine years ago as a Bioanalyst after graduating from Newcastle University with a degree in Pharmacology. In my early career, I was responsible for processing samples using ICP-MS, LC-MS and GC-MS technologies, as well as peer-reviewing analytical data generated by fellow scientists.
Over time, I expanded my expertise to include proposal development, client support and business management activities. This led to my appointment as Head of Bioanalytical Business Management and Quality Control. In December 2022, I became Head of Bioanalytical Services, where I now lead our Bioanalytical team and oversee the delivery of high-quality bioanalytical solutions to support our clients' drug development programmes.
How is ICP-MS Used in Drug Development?
- Sensitive quantification of elemental compounds
- Supporting pharmacokinetic and toxicology studies
- Fast and efficient analysis
Inductively Coupled Plasma Mass Spectrometry (ICP-MS) is a highly sensitive analytical technique used for elemental analysis. The concentration of one or multiple elements can be measured in a wide range of biological matrices, including blood, plasma, urine, tissues and faeces.
ICP-MS is particularly valuable when a compound contains a traceable element or when treatment effects can be monitored through elemental biomarkers. In these cases, ICP-MS can provide sensitive and robust quantitative data to support pharmacokinetic, toxicological and biomarker studies.
Another key advantage of ICP-MS is its efficient workflow. Sample preparation is typically straightforward, using acid or alkaline digestion techniques, and analytical run times are relatively short. This allows for rapid data generation and accelerated study turnaround times.
What is LC-ICP-MS Analysis?
LC-ICP-MS combines Liquid Chromatography (LC) separation with the elemental detection capabilities of ICP-MS. This technique is particularly useful when the element of interest is associated with multiple molecular forms or is bound to different proteins within a biological matrix. The LC system separates the individual species or proteins, while the ICP-MS detector quantifies the element present within each fraction.
LC-ICP-MS is therefore a powerful tool for elemental speciation studies and advanced elemental bioanalysis, enabling researchers to better understand biological distribution, protein binding and biotransformation pathways.
What expertise does Arcinova have in elemental bioanalysis?
Regulatory Leadership and Industry Involvement
Stuart McDougall is our Bioanalytical Principal Research Fellow with over 30 years of experience in the field. He has been an active member of both the European Bioanalysis Forum (EBF) and the American Association of Pharmaceutical Scientists (AAPS). In 2022, Stuart contributed to the EBF’s workshop and discussions surrounding the implementation of ICH-M10, the global bioanalytical method validation guideline that came into effect in January 2023. This landmark guidance harmonised bioanalytical requirements across major regulatory regions, including those governed by the FDA, EMA, PMDA and ANVISA.
Proven Method Development and Validation Expertise
Whether quantifying trace metals, characterising elemental species or analysing complex tissue samples, our Method Development team has decades of experience developing robust ICP-MS bioanalysis methods and quantitative elemental analysis assays. We have successfully delivered challenging projects involving total metal quantification, arsenic speciation, copper analysis and quantitative tissue analysis. Explore the techniques, challenges and solutions behind these studies in our on-demand webinar.
Following method development, our Bioanalysts perform bioanalytical method validation in accordance with ICH M10 requirements and support both clinical and non-clinical sample analysis using state-of-the-art ICP-MS and ICP-MS/MS instrumentation. Working closely with our Responsible Scientists, the team ensures the delivery of high-quality, regulatory-compliant data that meets the needs of our clients and regulatory authorities.
Does Arcinova Have Advanced ICP-MS and LC-ICP-MS Capabilities?
Arcinova supports elemental bioanalysis across the full spectrum of drug development, from preclinical research through to Phase III clinical studies.
Extensive Matrix and Study Experience
Our team has developed and validated numerous elemental bioanalysis assays for a broad range of matrices, including blood, plasma, urine, faeces and tissues. These assays have supported dose-ranging studies, GLP toxicology programmes and clinical trials across multiple therapeutic areas.
Elemental ADME for Challenging Molecules
For New Chemical Entities (NCEs) that cannot be readily quantified using conventional LC-MS-based approaches, but contain a unique elemental signature, we can provide comprehensive elemental ADME (Absorption, Distribution, Metabolism and Excretion) studies and bioanalytical support. This approach enables the tracking of compounds throughout drug development programmes using elemental detection techniques.
LC-ICP-MS for Speciation and Biotransformation Studies
We also offer advanced elemental profiling and speciation capabilities through LC-ICP-MS, helping to characterise biotransformation pathways and investigate the distribution of elemental species within biological systems.
Specialist Sample Preparation Capabilities
For complex sample types requiring extensive preparation, such as tissues, food samples or excreta, we utilise a range of homogenisation technologies, including bead homogenisation, ultrasonic processing, Turrax systems and Stomacher technology. In addition, our high-capacity Ultrawave microwave digestion platform enables efficient and reproducible preparation of challenging sample matrices.
Pharmacodynamic Biomarkers and Complex Analytical Challenges
Beyond pharmacokinetic applications, we have significant experience supporting pharmacodynamic biomarker studies, monitoring elemental changes associated with disease progression and therapeutic intervention. Our scientists have worked with a wide range of elements, from antimony to zinc, enabling us to collaborate closely with clients to overcome complex analytical challenges and deliver reliable, high-quality data on time.
Conclusion
Elemental bioanalysis provides a powerful approach for quantifying metal-containing therapeutics, investigating elemental biomarkers and supporting ADME studies throughout drug development. With extensive expertise in ICP-MS bioanalysis and LC-ICP-MS analysis, regulatory-compliant bioanalytical workflows and advanced sample preparation capabilities, Arcinova helps clients generate the high-quality data needed to make confident development decisions. From early preclinical research through to late-stage clinical studies, our team delivers tailored elemental bioanalysis solutions to support successful drug development programmes.
Interested in discussing your elemental bioanalysis requirements? Contact our team here to learn how Arcinova can support your next study.