Residual host cell DNA must be minimized as much as possible during production of therapeutic proteins. The removal or reduction of host cell DNA is, therefore, mandatory for biopharmaceuticals, requiring accurate and sensitive tests to quantify such impurities and to meet guidelines established by regulatory agencies.
Coming soon – USP will offer two highly characterized Reference Standards for residual host cell DNA: CHO genomic DNA and E. coli genomic DNA with the following benefits:
Additionally, USP General Chapter <509> Residual DNA Testing that features:
USP offers additional Performance Standards - broadly applicable standards that are used to ensure and demonstrate methods and process performance throughout the product lifecycle of a biologic.
Coming soon – USP Reference Standards for CHO and E.coli DNA
• CHO Genomic DNA RS (catalog #1130710)
• E. coli Genomic DNA RS (catalog #1231557)