Biopharmaceutical products require the removal of host cell impurities as a critical step in product purification. Companies that produce biopharmaceutical products must verify the quantity of host cell DNA impurities carried over through the purification process and in the drug’s final dosage to meet or exceed regulatory guidelines.
Avance Biosciences has developed a number of accurate and sensitive target-specific QPCR assays to detect residual host cell DNA in biopharmaceutical products from a number of common host cell lines (E. coli, CHO cells, and yeast). Our custom-designed GMP/GLP compliant qPCR method offers a powerful tool to address the safety concerns and satisfy the requirements for regulatory agencies worldwide.
With our expertise and extensive experience in the “Gold-standard” real-time qPCR assay development and validation, Avance Biosciences offers customized residual DNA analysis services to determine the residual host cell DNA in biological products derived from cell substrates.