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

DUBLIN--(BUSINESS WIRE)--The "Method Development and Validation for Assays Supporting Testing of Biologics" conference has been added to ResearchAndMarkets.com's offering. This 2-day seminar is ...

DUBLIN--(BUSINESS WIRE)--The "Method Development and Validation for Assays Supporting Testing of Biologics" conference has been added to ResearchAndMarkets.com's offering. Biologics continue to be a ...

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 ...

WILMINGTON, N.C.--Pharmaceutical Product Development, LLC (PPD) is expanding its cGMP cell-based assay laboratory in Middleton, Wis., to meet the growing needs of clients seeking to validate bioassays ...

Drug-induced QT interval prolongation and Torsades de Pointes (TdP) arrhythmias are the leading causes for drug withdrawals from market and compound attrition during drug development. To assess ...

The guidance clarifies what sponsors should consider when putting together an application for the validation of a NAM ...

A LAMP-based, visually read assay enables rapid FSHR N680S genotyping from buccal swabs, potentially allowing pre-cycle ...