Biological products can contain residual DNA from host cell substrates. It is therefore
possible that such residual DNA could encode or harbor oncogenes and infectious agents …

Although most biopharmaceuticals are highly purified, there is a theoretical concern that
such recombinant products could be contaminated with oncogenic or bacterial DNA. A …

Host cell DNA contamination occurs during the production of biopharmaceuticals and must
be controlled and monitored for the purity and safety of the drug products. A sodium iodide …

Recent advances in techniques for the isolation and rejoining of segments of DNAnow
permit construction of biologically active recombinant DNA molecules in vitro. For example …

Reliable and sensitive assays are required to determine whether a pharmaceutical product
meets current regulatory guidelines for residual host cell DNA. In this study, the sensitivity of …

The synthesis of drug substances involves the use of reactive chemicals, reagents, solvents,
catalysts, and other processing aids. As a result of chemical synthesis or subsequent …

A workshop was held to discuss the uses of data on DNA adduct measurement in humans
and in experimental systemsin vitroandin vivo. The discussions focused principally on the …

In April 2004, the Health and Environmental Sciences Institute, a branch of the International
Life Sciences Institute, with support from the National Institute of Environmental Health …

Background The development of DNA‐based therapies holds great promise for the
treatment of diseases that remain difficult to manage using conventional pharmaceuticals …

Recombinant DNA techniques are capable of introducing genetic changes into food
organisms that are more predictable than those introduced through conventional breeding …