Validation Guidance for Residual Host Cell DNA Testing
Development of a manufacturing process for a biotherapeutic that ensures consistent quality, purity and safety is a critical step in successfully developing the drug, getting it approved by regulatory agencies, and bringing it to the market. Most biological drugs are produced in bacterial, yeast or animal cell lines and may still contain trace amounts of DNA from the host cells, even after a rigorous purification process. The presence of residual host cell DNA molecules in a biotherapeutic could potentially cause an adverse event or present a safety issue.
Download this whitepaper to discover how to conduct:
- Specificity and linearity assessments
- Range and accuracy assessments
- Quantitation limit and precision assessments