|Residual DNA testing by dilution||Dilution method is used when the level of DNA contamination is unknown or for samples from early stage of protein purification. Serial dilutions are performed on each testing samples and controls before qPCR analysis.|
|Residual DNA testing by extraction||Extraction method is frequently used when DNA contamination is known to be in pg/ml range, or testing samples demonstrate PCR inhibition, or the level of DNA contaminants is below the testing limit of the dilution method.|
|Residual DNA testing for sizing||Custom designed assays targeted in various length of PCR amplicons profile the length distribution of host DNA contaminants in a biologics product.|
- Custom qPCR assay design and validation
- Rigorous measures to prevent cross contamination between samples
- Separate PCR rooms used to prevent contamination from environment
- Wide dynamic range in testing limits covering 5 log range
- Validated ABI 7900HT platform used for testing
- Methods are validated per ICH guidelines
- A report with following information will be delivered:
- Summary of the assay
- Results of the quantification
- Tabulation of raw qPCR data
- Turn Around Time
- 1 week for routine batch release testing (for existing assays)
- 4 weeks for assay development, validation, and testing
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