An overview of quantitative PCR assays for biologicals: quality and safety evaluation.

Applications of real time quantitative PCR (Q-PCR) to the evaluation of biologicals quality and safety are discussed in the following areas: (i) endogenous retrovirus load quantification in production cell cultures, (ii) viral clearance studies, (iii) lot release testing, (iv) detection of specific viral contaminants for raw material screen and in-process control, (v) mycoplasma and bioburden detection, (vi) host cell DNA quantification, and (vii) genetic stability characterization of production cell lines.