TriApex recently concluded a successful appearance at the 19^th Annual Workshops on Recent Issues in Bioanalysis (WRIB), held April 7–11 in New Orleans, Louisiana. The event brought together over 1,000 professionals from pharmaceutical and biotechnology companies, contract research organizations (CROs), and regulatory agencies to explore the latest developments in bioanalysis.

Led by a team of bioanalysis experts, TriApex hosted an exhibition booth and presented its latest research findings, contributing to the broader dialogue on innovative analytical approaches in cell and gene therapy (CGT).

On April 9, TriApex unveiled a scientific poster titled “Establishment of a General qPCR Method for Detecting Nonclinical Biodistribution of CGT Products”. The poster presents a general qPCR method targeting the human-specific ST6GAL1 gene for assessing the nonclinical biodistribution of cell and gene therapy (CGT) products in nonclinical study. Existing methods, such as Alu-based assays or gender-specific markers, have limitations in specificity, sensitivity, and applicability across different tissues or species. The novel approach leverages a single-copy st6gal1 sequence, cloned into a plasmid standard, to enable precise detection of human-derived cells in nonhuman primates without cross-reactivity.

Method Validation covered specificity, accuracy (intra-run: -15.45% to 17.15%; inter-run: -4.17% to 1.05%), sensitivity (50 copies/5 μL), and linearity (R²=0.999) across a 5-log dynamic range. The method demonstrated robustness across various cynomolgus monkey tissues and blood, showing consistent extraction recovery (54–56%) and stability under varied storage conditions.

Unlike previous methods, it eliminates gender dependency and improves specificity in primate models, while providing broad applicability to various tissue types and CGT products without requiring extensive re-validation. Comprehensive validation aligned with regulatory guidelines confirms its utility for nonclinical safety assessments, helping to reduce development costs and timelines. This innovation addresses critical gaps in biodistribution analysis, offering a reliable and standardized tool to advance cell therapy research and facilitate regulatory compliance.

With the establishment and operation of the laboratory in the United States, TriApex's bioanalytical service capabilities have reached a new level. TriApex US Lab is equipped with three core technical platforms to offer concentration analysis and immunogenicity evaluation services for bio-therapeutic products. Our services span early-phase research, nonclinical studies, and clinical trials, including cell and gene level analysis, immunoassays, and biomarker studies.

The poster is available for download below. For more information about TriApex’s research or bioanalysis services, visit www.tri-apex.com or contact bd@tri-apex.com.

Establishment of a General qPCR Method for Detecting Nonclinical Biodistribution of CGT Products.pdf