Bioanalytical and ADME Laboratory Services

Selecting the Right Bioanalytical Approach for Your Program

Modern therapeutic modalities often require specialized analytical strategies. Whether you're developing a small molecule, biologic, peptide, ADC, oligonucleotide, or novel therapeutic, selecting the appropriate bioanalytical platform is critical to generating reliable data and advancing your program with confidence.

Ligand Binding Assays, LC-MS, or Both?

Different analytical platforms answer different scientific questions. Ligand binding assays offer exceptional sensitivity for many biologics and biomarkers, while hybrid immunocapture LC-MS approaches can deliver enhanced selectivity, molecular specificity, and multiplexing capabilities for certain proteins, peptides, biomarkers, and complex therapeutics. Rather than forcing a one-size-fits-all solution, IQVIA Laboratories evaluates your molecule, study objectives, regulatory requirements, and development stage to recommend the approach best suited to your program.

Integrated PK and Biomarker Strategies Deliver Greater Efficiency

Pharmacokinetic (PK) and biomarker data are often most valuable when generated through a coordinated analytical strategy. In many cases, PK and biomarker testing can be managed by the same provider, simplifying study execution and creating a more integrated view of drug exposure, biological activity, safety, and efficacy. By supporting both disciplines within a single laboratory network, IQVIA Laboratories can streamline sample management, improve communication across study teams, reduce operational complexity, and deliver more consistent datasets throughout development.

Not every biomarker program requires a custom assay. Existing validated or fit-for-purpose methods may be appropriate when established biomarkers and performance characteristics meet study requirements. However, novel targets, emerging therapeutic modalities, unique sample matrices, or specific sensitivity and selectivity requirements may necessitate custom biomarker assay development. Our scientists evaluate the biological question being asked, biomarker characteristics, PK and biomarker study objectives, and regulatory considerations to determine whether an existing assay can meet your needs or if a customized approach will provide greater confidence in the data.

By bringing PK, biomarker, bioanalytical, immunogenicity, and ADME expertise together under one scientific framework, IQVIA Laboratories helps biopharma teams select the right assays, generate meaningful data, and make informed development decisions with confidence. This consultative approach ensures analytical strategies are tailored to the needs of each program while supporting efficient progression from discovery through commercialization.

HRMS or LC-MS/MS: Determining the Best Fit for Your Analytical Challenge

Both HRMS and LC-MS/MS play important roles in modern bioanalysis. LC-MS/MS is often preferred for highly sensitive, targeted quantitation in regulated studies, while HRMS can provide additional molecular insight through accurate mass measurements, metabolite identification, impurity characterization, and non-targeted analysis.

For some applications, HRMS may also improve analytical selectivity by distinguishing compounds with similar masses and reducing potential interferences in complex biological matrices. This capability can be particularly valuable for challenging biomarkers, oligonucleotides, metabolites, and other analytes where greater specificity is needed to confidently characterize or quantify the target of interest.

However, HRMS is not necessary for every biomarker program. The optimal analytical approach depends on factors such as biomarker complexity, required sensitivity, matrix interference, study objectives, and regulatory requirements. In many cases, traditional LC-MS/MS provides the sensitivity, robustness, and throughput needed to support regulated bioanalysis. In others, HRMS may offer additional confidence and insight that can help answer more complex scientific questions.

Our scientists work closely with biopharma teams to evaluate these considerations and determine when the enhanced selectivity and characterization capabilities of HRMS provide meaningful value and when a traditional LC-MS/MS approach is the most efficient path forward. This consultative approach ensures that analytical strategies align with your scientific objectives, development timelines, and regulatory expectation.

We are bioanalytical experts and an extension of your team, guiding the entire drug development journey.

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