Full-Service QC Laboratory for Clinical and Commercial Products
Our Quality Control (QC) laboratory boasts state-of-the-art instrumentation. We provide comprehensive support for our clients’ clinical and commercial manufacturing programs, conducting rigorous testing for raw materials, in-process, final product (lot) release and stability studies.
-
In-House Analytical and Microbiology Laboratories
-
Method development, transfer, qualification and validation
-
Raw material, in-process, lot release and stability sample testing
Chromatography experts across multiple platforms, including HPLC, UPLC with detection by MS, UV, PDA, fluorescence and CAD detectors
-
In-house, validated methods for bioburden, endotoxin and sterility utilizing isolator technologies
-
Lyophilized drug product testing
-
Osmolality by freezing point depression (FPD) and vapor pressure (VP) per USP<785>
-
UV/Vis, FTIR, Karl Fischer (KF), density, viscosity, break-loose/glide force testing
-
Container closure integrity testing (CCIT) by vacuum decay (Veripac)
-
Protein assays, including ELISA, SDS-PAGE and IEF
-
Compendial testing per USP/EP