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Development of a novel sample pretreatment method to optimize drug tolerance and maintain sensitivity for immunogenicity assessment of biotherapeutics - WRIB 2025

As modern biotherapeutics with improved safety profiles are administered at higher doses to achieve optimal therapeutic effectiveness, it becomes increasingly difficult to achieve suitable drug tolerance in anti-drug antibody (ADA) assays.

Scientific Posters

Bioanalytical Strategies for Antibody Drug Conjugate Development

Scientific Posters

Development of Critical Quality Attributes as part of Antibody Drug Conjugate Control Strategy

Scientific Posters

Qualification of a Novel Multiplex Assay for the Quantitation of Chemokine Markers in Human Plasma and CSF Samples – NBC 2025

Featured

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 for the different components of these drug modalities. Pharmacokinetic (PK) measurements include measurement of the encapsulated mRNA and components of the LNP in circulation to understand the effectiveness of the therapeutic mRNA.

Publications

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…

Publications

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…

Publications

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…

Featured

Strategies to Reduce Risk in Multi-Site Assay Cross-Validation

Discover best practices for achieving inter-laboratory concordance while supporting reliable bioanalytical data and regulatory confidence throughout global clinical development.

Webinars

LC/MS Strategies for Advanced Modalities: ADC, AOC, Multidomain, and RNA Therapeutics

This webinar highlights LC/MS-based strategies for the detection of novel drug modalities to support accurate, reliable, and fit-for-purpose PK analysis.

Webinars

Technical Considerations of RT-qPCR Pharmacokinetic Assays for LNP‑mRNA Drug Products

This insider session explores technical considerations for validation of regulated RT-qPCR assays that are used to support the pharmacokinetic analysis of LNP-mRNA drug products.

Webinars

Bioassay Method Transfer Strategies to Reduce Variability

Learn how bioassay method transfer strategies support reliable assay performance and minimize variability in this insider session. Explore case studies that highlight the challenges and…

Featured

Scaling Bioanalysis Without Compromise: Inside BioAgilytix Automation

From integrated systems and streamlined workflows to harmonized processes across the U.S., Europe, and Australia, our automation strategy is designed to increase efficiency, reduce variability, and support the demands of complex modalities. Watch to learn more

Videos

BioAgilytix CMC Analytical Capabilities

Videos

BioAgilytix’s LC/MS Global Expansion with Lynn Kamen and Dave Beyerlein

This video was initially created by Bioanalysis Zone and the original version can be found here.

Videos

BioAgilytix Capabilities: Scale and expertise for every phase of your study

Featured

Economical Preclinical PK Immunoassay

A start-up biotechnology company developed a library of constructs having the Fc portion of human IgG and their warhead denoted as X for confidential reasons. Fc-X fusion protein drug candidates were distinguished by amino acid substitutions in the warhead moiety, changes that were predicted to affect PK characteristics.

Case Study

Increasing Assay Sensitivity

Case Study

PK Assay For Therapeutic Antibody Quantification In Sodium Heparin Plasma

While conducting the pre-validation stage of a pharmacokinetic assay study, a sponsor asked BioAgilytix to develop a method for analyzing a specific therapeutic antibody when…

Case Study

Use Of MSD-ECL In Support Of Multiplex Biomarker Study

Blog

The Difference Between Pharmacokinetics and Pharmacodynamics

If you’re searching for the “difference between pharmacokinetics and pharmacodynamics (PK/PD)” or wondering “what is PK vs PD in drug development,” this article provides a…

Blog

Enabling a Breakthrough in Gene Therapy: A Case Study in Analytical Support for CRISPR-Based Innovation

In March 2025, a landmark moment in gene therapy quietly reshaped what’s possible in the treatment of ultra-rare diseases. A team at Children’s Hospital of…

Blog

Unraveling the Biosimilar Paradox

Riding a wave of blockbuster molecule patent expirations, the global biosimilar market grew to nearly $18 billion in 2020. With a total of 26 blockbuster…

Blog

CMC Analytical Control Strategies for Drug Development

CMC (chemistry, manufacturing, and controls) is a term used when drug developers define their investigative drug substance, establish manufacturing methods for…

Molecular Moments Podcasts

[EPISODE 27] CEO of BioAgilytix Davide Molho, Discusses Passion, Innovation, and the Future of the CRO Industry

In this episode of Molecular Moment, host Jim McNally, Ph.D., welcomes Davide Molho, DVM, the new CEO of BioAgilytix, to discuss his background, interests, and…

Molecular Moments Podcasts

[Episode 26] Drs. Shashank Gorityala, Ben Nie, and Amanda Hays talk LC/MS bioanalysis, platforms, matrices, workflows, and regulations

Molecular Moments Podcasts

[EPISODE 25] Adam Stasio Talks Large Data Sets, Breaking Down Problems, and Tech-Driven Solutions

Molecular Moments Podcasts

Resources

Posters

Development of a novel sample pretreatment method to optimize drug tolerance and maintain sensitivity for immunogenicity assessment of biotherapeutics - WRIB 2025

Bioanalytical Strategies for Antibody Drug Conjugate Development

Development of Critical Quality Attributes as part of Antibody Drug Conjugate Control Strategy

Qualification of a Novel Multiplex Assay for the Quantitation of Chemokine Markers in Human Plasma and CSF Samples – NBC 2025

Publications

Technical Considerations of Pharmacokinetic Assays for LNP‑mRNA Drug Products by RT‑qPCR

Technical Considerations of Pharmacokinetic Assays for LNP‑mRNA Drug Products by RT‑qPCR

Why is Biomarker Assay Validation Different from that of Pharmacokinetic Assays?

Assessment of Neutralizing Antibody Activity in Clinical Studies: Use of Surrogate Measurements Instead of Stand‑alone Assays

Webinars

Strategies to Reduce Risk in Multi-Site Assay Cross-Validation

LC/MS Strategies for Advanced Modalities: ADC, AOC, Multidomain, and RNA Therapeutics

Technical Considerations of RT-qPCR Pharmacokinetic Assays for LNP‑mRNA Drug Products

Bioassay Method Transfer Strategies to Reduce Variability