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BIOLOGICAL PHARMA CENTER
Analytics Development
Analytics provides the information for the quality of the product itself, as well as the levels of impurities. By providing sensitive and accurate analytical data, analytics can help upstream development by performing spent media analysis, or downstream purification by analyzing protein products.
| Subject | Characteristics | BIOLOGICAL PHARMA CENTER’s Analytical Methods |
|---|---|---|
| Spent Media | Expressions (titer) Amino Acids Vitamins | HPLC, biosensor (Octet) HPLC HPLC |
| Proteins | Concentration Integrity Heterogeneity Aggregation Charge variants Glycosylation Thermostability Binding activity Viscosity Turbidity | UV spectrometer CE-SDS, SDS-PAGE, MassSpec MassSpec (intact, subunit, peptide mapping) SEC-MALS, 96-well DLS, Non-reducing SDS Page Capillary isoelectric focusing (cIEF), HPLC-IEX Released glycan by HPLC, MassSpec for attached glycan DSF Octet, ELISA Visometer Vis spectrometer |
| Impurities | Endotoxin HCP Protein A Residual DNA | LAL ELISA ELISA qPCR |
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