En
In the field of biopharmaceuticals, process-related impurities mainly include those originating from cell substrates, cell culture, and downstream processes. These process impurities may affect the safety and efficacy of the final drug product.
Specializing in CRO services, INOMIXO conducts quality research on process impurities in the production processes of biologics and pharmaceuticals, identifying and evaluating these impurities, and performing qualitative or quantitative analysis.
Category | Compounds | Platform |
HCP residues | HCP residues | ELISA |
Total protein detection | Bradford | |
HCD residues | HCD residues | qPCR/ Fluorescent method |
Inducer | MSX | LC-MS/MS |
IPTG | ||
Antibiotic | Ampicillin | |
Carbenicillin | ||
Kanamycin | ||
Neomycin | ||
Defoamer | Dimethyl silicone oil | UPLC-CAD |
Polypropylene glycol | ||
Polyether defoamer | ||
Transfection reagent | PEI | LC-MS/MS |
Inhibitor | CHIR99021 | |
A83-01 | ||
Vaccine inactivator and adjuvant | Sodium deoxycholate | LC-MS/MS |
Cetyltrimethylammonium bromide (CTAB) | ||
MPLA | GC-MS | |
Propylene carbonate | ||
Downstream process | Enzymes | LC-MS/MS |
Ionic (Na+,K+,Cl-) | UPLC-CAD | |
EDTA/Tris/ | ||
Urea/ Imidazole | LC-MS/MS | |
Tres | ||
TNBP | ||
Excipients | Amino acids | LC-MS/MS |
Sucrose, Lactose, Glucose | UPLC-CAD | |
Sorbitol, Mannitol | ||
Tween 20/80 | ||
Recombinant albumin | ELISA | |
Solvent | Methanol, Ethanol, | GC-MS |
Acetonitrile, Pyridine |
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