Compares ddPCR systems for BRAF V600E detection, highlighting differences in sensitivity, automation, throughput, and precision.
Shows whole blood providing higher sensitivity and easier handling than PBMCs for RCL quantification, offering a faster, practical alternative with comparable accuracy.
Comparing 26- and 13-color panels showed the smaller panel maintained precision and agreement for key immune populations, supporting its use in streamlined clinical assays.
CryoStor CS10 showed the most consistent results among whole blood preservation methods, offering a viable alternative to PBMCs in multicenter trials.
Validated qPCR assays detected AAV vector shedding across five body fluids, highlighting the importance of reagent quality control for accurate gene therapy monitoring.
Analysis of 66+ PCR validations showed optimal matrix-platform pairing is critical for precision and low limits of detection in bioanalysis.
Assessed extraction platforms across serum, plasma, urine, and PBMCs to identify optimal methods for high-throughput qPCR workflows.
Developed and validated a sensitive ECL immunoassay to reliably measure C3a/C3a desArg in human plasma.
Validated an ECL method for precise quantitation of complement C3 in human serum samples.
Developed and validated pharmacokinetic assays for a biparatopic antibody to support clinical study needs.
Designed and validated qPCR assays to detect replication-competent retroviruses and lentiviruses in therapeutic T cells.
Explores solutions for transferring complex bioanalytical assays while maintaining precision and reproducibility.
Developed a robust method to measure ADAs against bevacizumab despite interference from soluble VEGF.
Addresses strategies for accurate, reproducible flow cytometry in regulated clinical studies.
Performed multi-parameter biomarker analysis to characterize the LRRK2 knockout rat model across platforms.
Presents methods to confirm flow cytometry assay reliability for clinical trial biomarkers.
Provides recommendations for demonstrating equivalency of ready-to-assay cells post-validation in NAb assays.
Highlights challenges and solutions in evaluating immunogenicity of PEGylated therapies.
Shows a fast, efficient approach to optimizing immunogenicity assays with design of experiments.
Highlights strategies for testing immunogenicity in therapeutics affected by pre-existing antibodies.
Demonstrates development of pharmacokinetic and anti-drug antibody assays for biosimilar Trastuzumab.
Shows GLP validation of a Gyrolab® assay measuring IL-8 levels in cynomolgus monkey serum.