Development and validation of a quantitative real-time PCR method for determination of residual host DNA in recombinant human C1 esterase inhibitor (rhC1INH).
A quantitative real-time polymerase chain reaction (qPCR)-based method was established and validated for the detection of residual host DNA in recombinant human C1 esterase inhibitor (rhC1INH), a biopharmaceutical produced in the mammary glands of transgenic rabbits. DNA was extracted from rhC1INH samples using a sodiu...