Biologics stability testing in pharmaceutical R&D typically requires weeks of waiting between processes. Formulation scientists must develop, assess, and then wait to discover if a formulation remains ...

Comprehensive guide on ICH Q1A(R2) storage conditions, testing intervals, stability data for IND/NDA submission, and designing FDA-compliant stability programs ...

MilliporeSigma, the U.S. and Canada life science business of Merck KGaA, Germany, says it has launched the first all-in-one, validated genetic stability assay of its kind. The Aptegra™ CHO genetic ...

ICH stability chambers with continuous monitoring for long-term, intermediate, and accelerated studies supporting FDA submissions and retailer qualification IRVINE ...

GMP release and stability testing are indispensable elements of the pharmaceutical sector’s quality assurance strategy. These testing protocols not only ensure that pharmaceutical products are safe ...

PITTSBURGH — The new International Council for Harmonisation (ICH) Q1 draft guideline on stability testing of drug substances and drug products is an attempt to revise the current ICH Q1 guideline, ...