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

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

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 ...

Coagulation testing is commonly performed in hospital systems to screen for potential bleeding or thrombotic disorders. Examples of patient populations and clinical applications include outpatients ...

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 ...

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

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 ...

Hit identification and hit validation represent distinct but connected stages of early drug discovery. This article examines how HTS, hit triage, and validation assays reduce false positives and ...

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

Approved biological products are required to be accompanied by analytical tests to demonstrate safety, purity, and potency. Manufacturing and testing processes for approved products are validated and ...