This article is recognized as a 2026 High Impact Article by the AAPS Journal. This AAPS working group paper provides industry considerations for the design, development, and validation of qPCR and dPCR assays used in regulated bioanalysis for cell and gene therapies. Developed by 37 experts from 24 organizations,…

This case study describes the development and validation of an ELISA method to quantify total antibody (tAb) from PYX-201, an investigational antibody-drug conjugate (ADC) developed by Pyxis Oncology. The assay was validated in rat and monkey plasma and used to support preclinical studies and an IND filing. The method…

This case study describes the development and validation of an ELISA method to quantify total antibody (tAb) from PYX-201, an investigational antibody-drug conjugate (ADC) developed by Pyxis Oncology. The assay was validated in rat and monkey plasma and used to support preclinical studies and an IND filing. The method…

This article provides updated recommendations for the bioanalysis of antibody-drug conjugates (ADCs), reflecting more than a decade of advances in the field. Developed by the AAPS ADC Working Group, it addresses key considerations for quantifying total antibody, conjugated ADC, free payload, and drug-to-antibody ratio (DAR), as well as immunogenicity,…

This article provides harmonized recommendations for the validation and reporting of neutralizing antibody (NAb) assays, addressing challenges associated with both cell-based and non-cell-based formats. Developed by experts from industry and the FDA through the American Association of Pharmaceutical Scientists’ Therapeutic Product Immunogenicity Community, the recommendations cover key assay performance…

Bispecific protein therapeutics present unique challenges for pharmacokinetic (PK) characterization because multiple functional domains must be evaluated, along with potential biotransformation and interference from anti-therapeutic antibodies. This review presents case studies and a regulatory perspective on developing PK assay strategies for bispecific molecules, emphasizing the need to consider each…

This paper, a collaboration between SCIEX and KCAS Bio, presents comprehensive LC-MS workflows for the quantitative analysis of antibody-drug conjugates (ADCs). Using trastuzumab deruxtecan as a model ADC, the study demonstrates sensitive quantification of free payload, total antibody, and conjugated ADC, highlighting the analytical performance and broad dynamic…

KCAS Bio collaborated with Phenomenex to demonstrate how magnetic bead-enabled hybrid LC-MS workflows are advancing modern bioanalysis for increasingly complex biotherapeutics. The case study explores how magnetic bead-based affinity capture enhances selectivity, sensitivity, and multiplexing, enabling more reliable quantitation of modalities such as monoclonal antibodies, ADCs,…

Discover in this poster presented by Rathna Veeramachaneni, Ph.D. at the American Society for Mass Spectrometry (ASMS) Conference in 2026 about the various developmental parameters to consider for fit-for-purpose validation of a novel multiplexed hybrid LC–MS/MS assay for the simultaneous quantitation of two abundant biomarkers in human heart tissue.

Discover in this poster presented by Andrew Bergdorf at the American Society for Mass Spectrometry (ASMS) Conference in 2026 about how we developed a streamlined, high-throughput proteomics workflow for human heart tissue that reduces sample preparation time while maintaining robust and reproducible biomarker detection. Key optimizations in…

Discover in this poster presented by Amrit Chakravarty, Ph.D. at the AAPS National Biotechnology Conference in 2026 about a high-sensitivity bioanalytical workflow combining single-use tip-based online cleanup on the Evosep Eno platform with a microflow LC-MS/MS setup on a SCIEX Triple Quad 7500+. The approach enables robust…

Discover in this poster presented by Taylor Dufield at WRIB 2026 about a fit-for-purpose multiplex LC–MS/MS workflow combining online and offline anti-peptide immunoprecipitation that enables sensitive, selective quantitation of protein biomarkers and binding partners from a single digested tissue sample across multiple species using a validated ICH M10-aligned approach.