background: existence of bacterial host cell dna contamination in biopharmaceutical products is a potential risk factor for patients receiving these drugs. hence, the quantity of contamination must be controlled under the regulatory standards. although different methods such as hybridization assays have been employed to determine dna impurities, these methods are labor, intensive and rather exp...

background contamination of therapeutic recombinant proteins with residual host cell dna must be controlled under the regulatory standards. objectives the current study established a new rapid, sensitive real time polymerase chain reaction (pcr) approach to measure the reliably of the residual escherichia coli (e. coli) host cell genomic dna in the recombinant streptokinase and alfa interferon ...

BACKGROUND Existence of bacterial host-cell DNA contamination in biopharmaceutical products is a potential risk factor for patients receiving these drugs. Hence, the quantity of contamination must be controlled under the regulatory standards. Although different methods such as hybridization assays have been employed to determine DNA impurities, these methods are labor intensive and rather expen...

one of the most important aspects in recombinant biologic production, based on gmp rules, is the accuracy of final product quality control, especially assessment of host cell macromolecules contamination rate in final product. the purification requirement can be eliminated when the yeast cell containing the recombinant protein is used as a host cell. it is possibile that the final product conta...

background and objectives: contamination of cell lines and biological products is one of the major problems of cell culture techniques. rapid detection of mycoplasma contamination in cell culture is an important part of quality control standards in related laboratories. the aim of this study was to evaluate the efficacy of pcr in detection of myroplasma as contaminants in cell cultures and othe...

the manufacture of biopharmaceuticals is purification of the drug substance. The downstream process must remove all contaminants, including host cell material such as DNA and cellular protein. Trace amounts of host-cell DNA and proteins can be copurified along with the drug substance. Such contaminants are obviously undesirable because of possible consequences if they are injected into patients...

Plasmid DNA is being used successfully as a gene delivery vector in a variety of clinical applications. Similar to other pharmaceutical products for clinical use, the plasmid vectors must meet rigorous purity standards. One important contaminant is the DNA of the host cell used to produce the plasmids. We have developed a new method to accurately quantitate E. coli host-cell DNA in plasmid prep...