AAPS PharmSci 360 2025: The Role of LC–MS in Bioanalysis

The field of bioanalysis in the development of bio/pharmaceutical products is advancing, and a variety of techniques is available to those working in the discipline. One such tool is liquid chromatography–mass spectrometry (LC–MS). Pharmaceutical Technology® spoke with Steve Lowes, senior director of Scientific Affairs at IQVIA Laboratories, ahead of AAPS PharmSci 360 to discuss how LC–MS is used in bioanalysis.

According to Lowes, while LC–MS can be more expensive and less sensitive than ligand binding assays (LBAs) for biologic analytes, the use of LC–MS is challenging the status quo. “Historically, we would also hear that the sensitivity is not what can be achieved with an immunoassay. I do think this latter challenge to LC–MS is being actively addressed, and I'm sure we'll get to talk about that in a moment,” he says. “However, the benefits of mitigating the challenges and the reliance on critical reagents associated with immunoassays leads to some interesting cost and efficiency assessments of LC–MS versus LBA.”

“I'm not saying that LC–MS is replacing LBA, but rather, with increasing frequency, we're seeing LC–MS to be the best tool for the job, including in biologic bioanalysis,” Lowes continues. “By that, I mean protein-based biologic drugs and oligonucleotide therapeutics. Integral to both of these are also the conjugated drug structures in a lot of oncology applications, where an antibody is directed to a tumor-associated antigen to deliver a cytotoxic payload. These are inherently complex molecules, and subsequently, so are the assays that we develop to address them. That is, we often are needing a free payload drug assay, a conjugated payload (i.e., the drug itself) and then the total antibody measurement as well.”

Steve will be monitoring the Rapid Fires: AI/ML in Bioanalysis session on Monday, Nov. 10, 2025 at 3PM CT at AAPS PharmSci 360 2025 being held Nov. 9–12 in San Antonio, Texas.

Click the video above to watch the interview.

About the speaker

Steve Lowes is Senior Director, Scientific Affairs at IQVIA Laboratories. Steve has 30+ years’ experience in bioanalysis with a focus on LC-MS and regulatory aspects and has been with the legacy LC-MS regulated bioanalytical lab of IQVIA Laboratories in Ithaca, NY since 1995. He is a regular presenter and author of publications on regulated bioanalysis, is co-editor of the text “Regulated Bioanalysis: Fundamentals and Practice,” and is the primary contributor to the popular Fit the Curve bioanalysis blog from IQVIA Laboratories. His most recent interests are the application of LC-MS to regulated bioanalysis of biologics and biomarkers. He received his bachelor’s degree in Analytical Chemistry at Sheffield Hallam University in the UK (1987) and a PhD in Biochemistry from the Open University, Milton Keynes, UK (1991).