Publications
Progress and promise of pharmacodynamic biomarkers: novel strategies and assay considerations in drug development
Pharmacodynamic (PD) biomarkers provide crucial insights into a drug’s mechanism of action (MoA) and efficacy by measuring its effects on biological targets within an organism.…
Technical Considerations of Pharmacokinetic Assays for LNP‑mRNA Drug Products by RT‑qPCR
Lipid nanoparticle-messenger RNA (LNP-mRNA) drug products are a growing class of drug modalities. The unique composition of these drug products requires multiple measurements to account…
Why is Biomarker Assay Validation Different from that of Pharmacokinetic Assays?
The Food and Drug Administration (FDA) issued a long awaited guidance document on Bioanalytical Method Validation for Biomarkers (BMVB) (1) in January 2025, which replaces…
Assessment of Neutralizing Antibody Activity in Clinical Studies: Use of Surrogate Measurements Instead of Stand‑alone Assays
Neutralizing antibodies (NAbs) to protein therapeutics have traditionally been assumed to be the most impactful subset ofanti-drug-antibodies (ADA). NAbs can block the biotherapeutic from engaging…
Optimization and qualification of an assay that demonstrates that a FimH vaccine induces functional antibody responses in women with histories of UTIs
Recurrent urinary tract infections (rUTI) are a serious disease associated with morbidities and mortality. Resistance to the standard of care antibiotics is now widespread because…
Best Practices and Recommendations for Non-Liquid Matrices Bioanalysis
The analysis of Non-Liquid Matrices (NLMs) can provide key information on many aspects in drug discovery and development. These include but are not limited to…
Development of a validated novel bead extraction method for the detection of anti-PEG antibodies in human serum
Polyethylene glycol (PEG) is used in many applications including drug development. Due to exposure to environmental products, there is a high prevalence of preexisting anti-PEG…
Immunogenicity assessment strategy for a chemically modified therapeutic protein in clinical development
The clinical immunogenicity assessment for complex multidomain biological drugs is challenging due to multiple factors that must be taken into consideration. Here, we describe a…
Identification and Biosynthesis of an N-Glucuronide Metabolite of Camonsertib
This is the first report of a glucuronide metabolite of camonsertib formed by human hepatocyte incubations. This study reveals the structure and stability of an…
Recommendations for Method Development and Validation of qPCR and dPCR Assays in Support of Cell and Gene Therapy Drug Development
The emerging use of qPCR and dPCR in regulated bioanalysis and absence of regulatory guidance on assay validations for these platforms has resulted in discussions…