Zencore Quality Control is established in accordance with FDA, EMA, and NMPA requirements.  Testing capabilities range from physicochemical, biochemical,  raw material, and microbiological.  Our Quality Control (QC) team provide customers with high quality services in DS/DP/placebo specification, raw material, in-process control, product release, stability testing, utility and environment monitoring for biological products.

QC scientists have extensive technical expertise and employ validated cutting-edge equipment in a fully GMP environment.

Physicochemical

Compendial: visible particles, color, clarity, volume, water, osmolality, pH, subvisible particulate matter

Content: protein content, polysorbate 20/80, glycan profile

Identity: pI, peptide mapping

Purity: SEC-HPLC, CE-SDS, charge variants (icIEF, AEX, CEX)

Biochemical

Residual DNA, HCP, residual protein A

ELISA antigen-antibody binding activity

Cell- based assay

Raw Material

TOC, conductivity

Identity, IR, optical rotation, impurity

Microbiological

Endotoxin

Bioburden

Sterility