GB/T 34777-2017
ActiveDetection of residual DNA in biological product which expressed from Chinese hamster ovary(CHO) cell—Fluorescent quantitative polymerase chain reaction assay
中国仓鼠卵巢（CHO）细胞表达产品残留DNA检测 荧光定量PCR法
Application Summary AI generated
This standard specifies the use of fluorescent quantitative polymerase chain reaction (qPCR) to detect residual host cell DNA in biological products, such as recombinant therapeutic proteins or antibodies, that are expressed using Chinese hamster ovary (CHO) cells. It is applied in the pharmaceutical and biotechnology industries during quality control and release testing to ensure that residual DNA levels in purified drug substances meet safety limits for human injection. The method is critical for validating manufacturing processes and confirming product purity in regulated biomanufacturing environments.
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Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.