The last two decades have witnessed the steady growth of the protein drug market. As original recombinant products come off patent, generics/ biosimilars are also beginning to be manufactured. The ...

Producing cGMP biopharmaceutical products requires controlled, consistent performance of the manufacturing process. cGMP also requires controlled, consistent performance of analytical test methods.

The implementation of the In Vitro Diagnostic Regulation (IVDR) has significantly transformed the regulatory and operational ...

Real-World Plasma Thymidine Kinase Activity in High-Risk and Metastatic Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Breast Cancer Treated With Cyclin-Dependent Kinase ...

Dr. Stephen will cover the process of developing and manufacturing reliable Luminex biomarker assays, as well as using those assays to test samples. She will examine the development of Ampersand ...

An increasing body of research indicates that more translational and relevant evaluations can be made utilizing 3D organoids and micro-tissues as opposed to 2D monolayer cell models. This is most ...

This talk will explore method validation in the digital lab using integrated and connected systems. Collecting validation data from various lab systems often involves navigating multiple challenges, ...

High-throughput screening (HTS) enables rapid discovery but introduces assay, automation, and data challenges. This article ...

Enzyme assays are evolving from traditional spectrophotometric methods to high-throughput, AI-powered platforms that accelerate drug discovery, diagnostics, and sustainable chemistry. Advances like ...

Company secures $5M in funding to accelerate its rapid testing platformUSP<1223> Validation achieved, reinforcing 20-hour testing ...