We control the quality of biologics produced from microbial fermentation by using state of the art analytical instrument.
We control the quality of biologics produced from microbial fermentation by using state of the art analytical instrument.
Quality control of intermediate product through: biological activity, protein content, specific activity, non-reduced SDS-PAGE & reduced SDS-PAGE，HPLC, host DNA residue, host protein residue, residual antibiotic activity, Isoelectric point determination, UV, peptide mapping, bacterial endotoxin, sterility, etc.
Quality control of drug product through: western blot or ELISPOT, appearance, visible particles, loading difference, moisture, pH, osmotic molar concentration, biological activity, antibiotic residue, sterility, bacterial endotoxin, abnormal toxicit.