INTRODUCTION

The following method is suitable for measurement of residual host cell DNA in recombinant therapeutic products produced in either Escherichia coli (E. coli) or Chinese hamster ovary (CHO) cell lines. Also provided is an extraction procedure that is suitable to be used prior to a quantitative polymerase chain reaction (qPCR)-based method for the measurement of residual host cell DNA. For discussion of the principles and best practices for this type of testing, see Nucleic Acid-Based Techniques—Approaches for Detecting Trace Nucleic Acids (Residual DNA Testing) 〈1130〉, which may be a helpful resource.