Center for Biologics Evaluation and Research

Validating Wing Biopsies for Blood‐Borne Pathogen Characterization in Bats

Wildlife surveillance is critical for tracking disease emergence, characterizing pathogen diversity, and assessing spillover risks. Blood-borne pathogens are of particular interest for such efforts due to their global distribution, broad host taxa, and zoonotic potential. Despite...

Assessing residual bias in real-world vaccine effectiveness studies: validating negative controls to avoid misleading results

Observational studies and randomized controlled trials demonstrate that vaccines protect against infections and severe outcomes, but real-world vaccine effectiveness estimates remain vulnerable to residual biases. Negative control outcomes can help detect and mitigate such biases...

A collaborative study evaluating the detection of virus-infected cells by transcriptomic high-throughput sequencing

High-throughput sequencing (HTS) is an agnostic virus detection technology that can replace or supplement the conventional adventitious virus assays used for safety testing of biologics. Transcriptomic HTS is particularly suitable for the detection of replicating viruses. We have...

An Explanation forthe 32 and 54 Da Losses Seen in N -Linked GlycanPermethylation Reactions

Abstract Permethylation is a widely used derivatization technique for mass spectrometry-based glycan analysis, applicable to both research and drug product characterization. It stabilizes sialic acids, improves glycan ionization, and is commonly used to analyze PNGase F-released...