——Impurity detection tools during bioproduction
Antibiotics are common cell culture-derived impurities in the bioproduction process. Antibiotic assays must be performed to ensure that the purification processes efficiently remove these chemicals so that they are at or below the maximum permitted levels and in line with any product-specific regulatory guidelines. The need for monitoring and controlling process-related impurities and contaminants in the bioproduction process is described in the ICH Q6B guidelines for the production of biological molecules.
Creative Diagnostics provides a panel of highly sensitive antibiotics ELISA kits to analyze antibiotic residues. These kits are suitable as good impurity detection tools to be used in the bioproduction process.
|Cat. No.||Product Name||Compatible Samples|
|DEIA048||Kanamycin ELISA Kit||Vaccine, Cell Culture|
|DEIA-WZ048V||High Sensitivity Kanamycin ELISA Test Kit||Cell lysate, Urine, Serum, Recombinant protein, Fermentation liquid|
|DEIA047||Gentamicin ELISA Kit||Vaccine, Cell Culture|
|DEIA-WZ6884||High Sensitivity Gentamicin ELISA Test Kit||Cell lysate, Urine, Serum, Recombinant protein, Fermentation liquid|
|DEIA040||Ampicillin ELISA Kit||Vaccine|
|DEIA-WZ020||High Sensitivity Streptomycin ELISA Test Kit||Serum, Urine, Recombinant protein|
|DEIA6881V2||Chloramphenicol ELISA Kit||Vaccine|