1. Universal real-time PCR assay for quantitation and size evaluation of residual cell DNA in human viral vaccines;Andre;Biologicals,2016
2. Chapter 3407. Determination of Residual Extraneous DNA;Chinese Pharmacopoeia,2015
3. European Medicines Evaluation Agency. CPMP/BWP/382/97 – CPMP Position Statement on DNA and Host Cell Proteins (HCP) Impurities, Routine Testing Versus Validation Studies;EMEA,1997
4. European Medicines Evaluation Agency. CPMP/BWP/1143/00 - CPMP Position Statement on the Use of Tumorigenic Cells of Human Origin for the Production of Biological and Biotechnological Medicinal Products;EMEA,2001
5. General Chapter 5.2.3. Cell Substrates for the Production of Vaccines for Human Use. Strasbourg, France;European Pharmacopoeia,2018