Introduction Secondary and tertiary packaging leachables are volatile, semi-volatile, or mobile chemical substances that originate from non-contact outer packaging materials, […]
Introduction Extractables Testing of Sterilizing-Grade Filters involves evaluating chemical compounds that migrate from filter materials under exaggerated solvent, temperature, and
Introduction Under Section 351(k) of the Public Health Service Act (PHS Act), an abbreviated Biologics License Application (aBLA) for a
Introduction: The Nitrosation Assay Procedure (NAP Test) is an experimental approach for investigating the nitrosation potential of amine-containing active pharmaceutical
Introduction The FDA Purple Book is an online database that enables biopharmaceutical researchers and regulatory specialists to assess FDA-licensed Section
Introduction Qualifying plastic manufacturing equipment under USP and requires a structured, risk-based chemical characterization approach to ensure that organic extractables
USP <665> and <1665>: How to Qualify Plastic Components Used in Drug Manufacturing Read More »
Introduction Evaluating Process Equipment-Related Leachables (PERLs) under 21 CFR 211.65 is an essential compliance requirement for pharmaceutical and biopharmaceutical manufacturers
Introduction: Small molecule API process development CDMO services help drug developers convert a promising synthetic route into a robust, scalable
Small-Molecule API Process Development and Scale-Up Services at a CDMO Read More »
Introduction Biosimilar nonclinical toxicity studies are no longer legally required to include in vivo animal testing following the enactment of
Introduction A situation in which a biosimilar comparative efficacy study is still required typically arises when high molecular complexity, a
