Bioanalytical Method Development and Validation Prolytix offers a wide assortment of assays for phase-appropriate bioanalytical development. We maintain these assays throughout the life cycle of your product. We also develop de novo assays for specific biomarkers. Contact us to discuss your clinical sample development needs. Select Areas of Expertise: Thrombin Generation Assay (TGA) Anti-Drug Antibody …
GMP Clinical and Commercial Drug Stability Testing To move your product from discovery to regulatory approval to commercial manufacturing, you must know how your product performs under both routine and stressed conditions. That’s where stability testing from Prolytix comes in. All Prolytix drug stability testing follows strict GMP compliance and takes place in our full-service, …
GMP Clinical and Commercial Release Testing Prolytix performs GMP release testing for both commercial and clinical trial drug substances and drug products. We test bulk, final product, and in-process materials in our fully compliant, FDA-inspected facility. Combined with our other chemistry, manufacturing, and control (CMC) and drug development services, you’re assured the highest quality from …
