Scientific Expertise

Whether you're pipetting in a preclinical lab, managing samples in a trial, or compiling data for a submission, compliance is the invisible thread stitching every step together. We unpack how biopharma teams align with regulatory expectations through GLP, GCP, GCLP, and the ever-growing library of regulatory guidelines.

A ligand binding assay (LBA) is a highly sensitive and specific method used to detect and quantify biomolecules like proteins, peptides, or antibodies by measuring their interaction with a target ligand. LBAs are widely used in clinical trials, especially for biologics and complex therapeutics, due to their ability to detect low-abundance analytes in complex biological samples. They are versatile tools applicable to pharmacokinetics, pharmacodynamics, immunogenicity testing, and biomarker analysis, and they scale well for high-throughput screening while meeting global regulatory standards. 

No single RNA analysis method fits every research need. RNA-Seq excels in discovery and scalability, NanoString offers robustness and simplicity for fixed panels, and qPCR provides speed and precision for low-plex validation. By aligning the method with the biological question, sample constraints, and available resources, researchers can maximize the impact and accuracy of their gene expression studies.

This study compares a 26-color and 13-color spectral flow cytometry panel to assess the impact of reducing markers. Using PBMCs from three donors, both panels showed strong precision and high agreement (within 20%) for key immune populations. The 13-color panel maintained comparable performance, supporting its use in clinical settings when full panel complexity isn’t needed.

This study assessed three whole blood preservation methods—CryoStor CS10, Cytodelics, and Smart Tube—as PBMC alternatives for flow cytometry. Using a 26-color panel, CryoStor CS10 showed the most consistent results. Cytodelics and Smart Tube had more variability, likely due to fixatives. CryoStor is a strong alternative, though donor variability and antibody re-titration should be considered.

Chimeric antigen receptor (CAR) T cell therapy has transformed hematological cancer treatment, with six therapies now approved by the FDA. Four of these therapies (tisa-cel, axi-cel, brexu-cel, and liso-cel) target CD19 using single chain variable fragments (scFvs) derived from the heavy and light chain variable (VH and VL) regions of the monoclonal antibody FMC63.

This study validated a qPCR assay for detecting AAV vector shedding in five body fluids. Results showed strong sensitivity and accuracy, with semen needing dilution. Variability in results was linked to pH changes in a key reagent, highlighting the importance of reagent quality control in gene therapy trials.

Over 80 PCR validations showed that acellular samples yield better precision and lower LoDs. easyMAG excelled with acellular matrices, QIAgen with cellular, and KingFisher delivered the lowest LoDs. Proper matrix-platform pairing is essential for accurate PCR bioanalysis.

April 16, 2025

Gain expert insights into flow cytometry calibration, validation, and standardization in this webinar with Dr. Virginia Litwin.

Live cell assays are vital for assessing immune responses and drug efficacy in clinical trials. Successful implementation requires clear objectives, efficient sample logistics, proper matrix selection, and stringent controls. Eurofins Clinical Trial Solutions ensures reliable assay performance to support accurate and meaningful trial results.