Critical steps in the manufacturing process are controlled with in-process tests (IPCs). These include:
- Transfection Efficiency: Monitored to ensure efficient vector production.
- Chromatography Elution Profiles: The elution of the product from each chromatography column is monitored by UV absorbance to ensure proper separation and collection of the product peak.
- Vector Genome Titer: An in-process qPCR test is performed after the final purification step to confirm vector recovery before final formulation.
- Bioburden: Samples are tested for bioburden at key intermediate steps to monitor the microbial state of the process.