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.
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)
Residual DNA, HCP, residual protein A
ELISA antigen-antibody binding activity
Cell- based assay
Identity, IR, optical rotation, impurity
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289 Zhengjia Road, Lin-gang Special Area, China (Shanghai) Pilot Free Trade Zone
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Building 31(F1), 356 Zhengbo Road, Fengxian District, Shanghai, China