Leveraging our well-established analytical platform and cutting-edge technologies, Zencore AS team offers efficient and high-quality analytical services. A comprehensive in-house platform methods covering compendial, physicochemical, biochemical, biophysical and biological method have been well established and project specific analytical methods can be developed based on the project needs.
The Bioassay team can provide the total solutions for any in vitro biological functional activities and the residual impurities:
The Mass Spectrometry team can provide customers with one-stop-shop solutions for characterization of drug substance and drug product and quality related research, which includes: primary structure and higher order structure, impurity characterization, charge variants characterization, quality comparability for IND or BLA, quality comparability for process changes and degradation products, similarity assessment, formulation screening studies, etc.
The Physicochemical Analysis team can provide a full range of testing services, including stability indicating analytical method development and validation for the identification, protein content, impurity/purity, and other quality-related test items. Capabilities includes:
appearance, pH, osmolality, moisture analysis, etc.
Peptide mapping, icIEF, SDS-Page, etc.
SEC, CE-SDS, HIC purity, etc.
N-glycan profile, O-Glycan Profile, sialic acid distribution (Z value), and the assay of sialic acid, etc.
Appearance, color, clarity, subvisible particles, visible particles, osmolarity, DLS, DSC, DSF, fluorescence spectra, infrared spectra, viscosity, density, moisture content of lyophilized preparations, pH, filling volume, etc.
long term, accelerated, stress, and forced degradation, etc.
The Biophysical team can provide biophysical characterization of biomolecules with state-of-the-art instruments, for example, DLS, DSC, DSF, fluorescence spectra, infrared spectra, AUC, and zeta potential analysis, etc.
