JSBio provides comprehensive, independent testing services to the biopharmaceutical industry, supporting cell culture media, raw materials, impurity analysis, cell-culture process development and product quality assessment. Validated methods, rigorous QC and regulatory-compliant practices ensure reliable, accurate data. Equipped with advanced instrumentation and experienced analysts, we deliver efficient, high-quality testing services.
| Test Item | Analyte | Typical Techniques |
|---|---|---|
| Raw materials and Impurities | Amino acids; Pluronic acid; Polysorbate 20 and 80; Vitamins, organic acids; Metals and salts | ICP-MS, LC with CAD, RI, QDa, FLD, UV-Vis |
| Cell culture media | Amino acids; Vitamins; Osmolality; Trace elements; Appearance; Solubility; pH | LC-MS, ICP-MS, HPLC, Turbidimeter, Osmometer |
| Spent media and metabolomics | Amino acids; Vitamins; Organic acids; Fatty acids; Intermediate metabolites | LC-MS |
| Physicochemical analysis | Particle distribution; residual moisture; loss on drying; TOC; Metals (K, Na, Fe, Mg, Ca, etc.); Trace elements (Cu, Mn, Zn, etc.) | Oven, Karl-Fischer, ICP-MS, TOC analyzer, Laser Particle Size Analyzer |
| Protein product quality attributes | SEC, AEX, CEX, RP, HIC, CE-SDS (reduced and non-reduced), iCIEF, cIEF, extinction coefficient, molecular weight by LC-MS, glycosylation | HPLC, PA800, Maurice, LC-MS, LC-FLD |
| Antibody potency | Bioactivity; Binding activity | Cell-based assay (ADCC, CDC), ELISA, Fortebio |
| Characterization analysis | Molecular weight (intact, reduce/deglycosylation), N/C-terminal sequence analysis, N-glycosylation site confirmation, disulfide bond analysis, PTM, sequence coverage, drug modification site, peptide mapping, isomerization analysis | LC-MS |
| Process related impurity | Protein A; DNA; HCP; insulin; PF68 | ELISA, qPCR, LC |
| Microbiological testing | Sterility; endotoxin; mycoplasma; bioburden | Scan RDI, Microplate reader, qPCR |
