Biopharmaceutical Analysis

In part two of an interview, Daniel Delubac, iOrganBio CEO, explains how digitized, in-vitro human biology models aim to improve preclinical drug testing.

In a new team-up, MD Anderson and SOPHiA GENETICS will apply advanced analytics to cancer testing to improve complex data interpretation for clinical use.

A look at interchangeable biosimilars gaining FDA approval, the growth in global partnerships, and the rising biologics patent cliff.

Advances in precision analytics have pushed the needle forward in characterizing and assessing the safety and quality of next-gen biologics.

FDA outlines reduced primate testing for monoclonal antibodies, signaling a shift toward modern evaluation tools that may influence drug development practices.

Microfluidic rapid-testing advances enhance real-time QC, strengthen compliance, and speed contamination detection across modern biomanufacturing.

Eric Hill, Chief Scientific Officer, BA Sciences, discusses the how E&L testing principles can be adapted to biologic products and the unique challenges biologic drugs face regarding E&Ls.

Eric Hill, Chief Scientific Officer, BA Sciences, discusses the analytical challenges involved in conducting E&L testing for biologic drug products.

Reliable bioanalysis and regulatory-compliant study design enhance drug development, says Alturas’s Sara Underwood at AAPS PharmSci 360.

At AAPS PharmSci 360, Ely Porter, PhD, says automated platforms enhance drug production velocity and assay excellence.

Performance advantages are driving adoption of membrane chromatography for advanced therapy purification.

A wide-ranging discussion with RNAnalytics’ Viktoria Enkmann touched upon the technology and equipment necessary for modern nanoparticle analysis, as well as global concerns.

In the conclusion of a two-part conversation, Viktoria Enkmann of RNAnalytics says she had a hard time understanding the United States’ mRNA decision in August 2025.

Silvia Scaglione of React4Life explores how organ-on-chip systems, AI, and multi-organ models are revolutionizing preclinical testing and advancing personalized therapeutics.

In the first of two parts, Viktoria Enkmann addresses problems with quality control for personalized medicines in the context of lipid nanoparticles and RNA therapeutics overall.

Enzyme engineering holds promise, but Marina Cañellas of Zymvol Biomodeling says the enzymes themselves need to be improved through increased discovery and investigation to be able to achieve a greater amount of chemical reactions.

Fluorescence spectroscopy with A-TEEM offers rapid, precise monitoring of cell culture media variability for improved biopharmaceutical quality control.

Naobios and Olon France create custom HCP ELISA to advance vaccine trials and strengthen global biopharmaceutical manufacturing capacity.

Formulation and analytics are combining to advance drug development synergistically, with evolving tools and related strategies shaping quality, scalability, and innovation.

Advances in digital technologies offer effective data handling for bio/pharma manufacturing.

The scaled adoption of cell and gene therapies demands a new era of agile, precise, and efficient quality control methods. Manufacturers and diagnostic partners must collaborate to create innovative, compliant testing strategies that preserve product integrity, meet tight timelines, and deliver life-saving treatments faster.

Data integrity and quality are paramount for drug discovery, manufacturing efficiency, regulatory compliance, and patient safety.

The growing cell and gene therapy (CGT) market is driving demand for innovative, robust diagnostics to meet scaling, regulatory, and quality needs.

Benjamin McLeod and Sebastian Lykke Skafte Andersen go behind the headlines to examine the motivations behind recent M&A activity, tariff responses, and more.

The agreement expands researcher access to backbone modifications that boost stability and delivery of RNA therapeutics across diverse applications.