Using qPCR in Place of Infectivity and TEM Assays
| Process Step | Current FIH Study | Streamlined FIH Studya |
|---|---|---|
| Cell Culture/Harvest (RVLP) | TEM | qPCR |
| Protein A Chromatography | qPCR | Not tested |
| Low pH or Detergent Inactivation | Infectivity | Infectivity |
| Other Chromatography | Infectivity | qPCR |
| Viral Filtration | Infectivity | qPCR |
↵a Bold text indicates changes in virus safety strategy of streamlined FIH studies compared with current FIH studies.