Stability testing is essential in the pharmaceutical and biopharmaceutical industries. These tests are performed to evaluate the stability of drug products under various environmental conditions. Once ...

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

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 ...

Dynamic Multimode Spectroscopy Found Niche for Monitoring Changes in Secondary Structure In recent years, antibodies and recombinant proteins have become well-established pharmaceutical therapeutics ...

Using two different buffers—histidine and citrate—but the same pH, the conformational stability as assessed by ICD was very similar. However, using DFD we were able to differentiate ultimate stability ...

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