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 GLP/GMP 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.
Avance Biosciences also offers Southern blot service to determine the size distribution of residual DNA contaminants in various steps of biologics manufacturing processes. DNA extracted from testing samples are separated by Agarose gel electrophoresis and detected by Southern blotting using a 32P labeled probe.
Genomics & Biological Services
Experienced scientists functioning as project managers or study directors
Independent quality unit assuring regulatory compliance
Methods validated per ICH GLP/GMP guidelines – also research grade testing available
Rigorous sample tracking and handling procedures to prevent mistakes and cross-contamination
Controlled laboratory environment to prevent cross-contamination