Bioanalysis Zone

This infographic highlights some of the challenges associated with biomarkers, which can arise due to their diversity, difficulties in measuring various data and the pressures of compliance and standardization. Explore methods to overcome the complexities of biomarkers and how a vital tool such as LC–MS can address these challenges by providing more reliable, accurate and precise data and quantification. [Illustrated by Tobias Dumbraveanu] In association with:

Biomarkers are reshaping the future of drug discovery and development with the promise of gaining an understanding of disease and possible treatments at the individual level and progressing the vision towards personalized medicine. Despite their promise, the journey to unlocking the full potential of biomarkers is not without its challenges. Turning biomarker data into meaningful insights is no easy task, as they can be difficult to measure with precision.

In the final installment of this three-part series, Katherine navigates the regulatory landscape, assesses single-target vs multiplex workflows, and explores the key parameters for validating PCR assays in regulated bioanalytical laboratories.

In this article, ICON details the validation and implementation of a 25-color spectral flow cytometry assay for comprehensive immunophenotyping in clinical trials, using the Cytek Aurora 5-laser platform. The article highlights assay performance, reproducibility, stability across various sample types, and its suitability for high-resolution immune monitoring in global clinical studies.

Bioanalytical (BA) data are foundational to clinical trial integrity and regulatory success. Yet, circumstances such as regulatory noncompliance, operational disruptions, resource limitations, or evolving analytical needs can necessitate a BA laboratory transition during a clinical trial. Through the lens of a real-world case study and supported by broader industry experience, this manuscript explores the operational, scientific, and regulatory challenges of BA laboratory transitions.

Tuesday 21 April 2026 07:00 [PDT] 9:00 [CDT] 15:00 [BST] Alternative time zones From assay strategy to data confidence: tackling preclinical bioanalytical challenges in ADC development Antibody-drug conjugates (ADCs) are a class of precision-based cancer therapies that have gained significant attention in the last decade of drug development.

In the second installment of this three-part series, Katherine discusses how qPCR, dPCR and ddPCR are being used for vector characterization, quality control, biodistribution and vector shedding studies.

Accurate quantification of oxidative mitochondrial DNA (mtDNA) lesions remains technically challenging due to the limitations of existing assays, which often require large sample inputs, multi-day workflows, and offer limited sensitivity. Here we introduce FALCON-qPCR (Fpg-assisted Long-PCR), a streamlined, high-sensitivity method for quantifying oxidative damage in mtDNA.

Flow cytometry continues to evolve as a cornerstone technology in bioanalysis, driven by rapid advancements in instrumentation and data analytics. The integration of high-parameter and spectral platforms with intelligent data processing tools is transforming how cell-based biomarker data is captured from precious clinical samples.

Microsampling necessity, challenges and advancements in preclinical and clinical bioanalysis. Mircosampling in both preclinical and clinical drug development can enhance patient experience, support the 3R aims, broaden clinical trial diversity via decentralized clinical trials, and help assess bioanalytical drug effects more frequently.