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Host Cell DNA Assay Re-Development and Qualification for a PEGylated Protein Drug Substance

Biologic drugs must ensure that DNA from the host cell (hc) is below a recommended limit set by the FDA.

Released By Bora Biologics

Biologic drugs must ensure that DNA from the host cell (hc) is below a recommended limit set by the FDA to be no higher than 100 pg/dose (or 10 ng/dose for high dose biologics). Residual hcDNA in a drug could have serious health implications for the patient, which is why the hcDNA assay is a critical release assay for biologic drugs in accordance with USP<509>. At Tanvex, two related biologic drugs, one PEGylated, and the other not, are produced from the same E. coli host cell bank. A feasibility study was conducted and showed that the already validated hcDNA method for the nonPEGylated protein could not be used for the PEGylated version of the drug. This poster covers the feasibility testing, method re-development and challenges faced working with a difficult PEGylated drug substance (DS). Various DNA extraction methods were tested, and one outperformed the others resulting in a fully qualified hcDNA assay which meets the USP<509> requirements.

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