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.
Now available – Two highly characterized Reference Standards for residual host cell DNA: CHO genomic DNA and E. coli genomic DNA with the following benefits:
- highly sensitive and specific residual genomic DNA measurement method
- optional protein extraction procedure to minimize sample matrix effects
- no kit required
- primer and probe sequences provided
- flexibility in labeling oligonucleotides
Additionally, USP General Chapter <509> Residual DNA Testing that features:
- a publicly available, validated method to detect residual genomic DNA
- confirmed primer and probe sequences that provide flexibility in choice of labeling reagents
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.