Posters & Papers
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…
Posters & Papers
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…
Posters & Papers
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,…
Posters & Papers
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…
Posters & Papers
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, the paper addresses the lack of harmonized guidance and acceptance criteria for these platforms…
Posters & Papers
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…
Podcasts
The main discussion in Episode #102 explores what KCAS scientific advisors are hearing from customers as face-to-face visits and industry interactions increase. The conversation highlights a major shift toward more complex therapeutics and targeted delivery strategies, including conjugates, protein shuttles, in vivo gene therapies, and technologies designed to cross…
Blogs
Quantifying antigen-specific T cell responses induced by vaccine candidates is a central challenge in immunogenicity monitoring. Among the available methods, the IFN-γ ELISpot assay is widely used for its ability to detect and enumerate individual cytokine-secreting cells, offering sensitivity suited to low-frequency responses.
October 13
- October 14
Join KCAS Bio at the Biomarkers, CDx & Precision Medicine -Europe 2026, taking place from October 13-14 in Basel, Switzerland. This European event unites pharma, biotech, and academic leaders to explore biomarker innovation, companion diagnostics, and precision medicine, with new 2026 tracks on spatial biology and computational pathology &…
webinars
ADCs are one of the fastest-growing therapeutic classes in drug development, with 80+ candidates now in the clinical pipeline. But every ADC creates multiple bioanalytical questions: free payload, conjugated payload, total antibody, and beyond. Each requires its own sample prep strategy, extraction decisions, and sensitivity considerations. In this…
October 21
- October 23
KCAS Bio will be attending the AusBiotech International Conference 2026, taking place October 21st–23rd at the Gold Coast Convention & Exhibition Centre in Queensland. As Australia’s largest life sciences conference, AusBiotech brings together the life sciences community to connect people, ideas, and opportunities. The conference provides a platform…
Blogs
Accurate pharmacokinetic data starts with confidence that the concentration measured by LC-MS/MS truly reflects what was present in the biological sample at the time of collection. For some small molecules, maintaining that integrity can be challenging. Structural features such as esters, lactones, aldehydes, and thiols may make a compound…