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Real-time PCR (qPCR) and digital PCR (dPCR) play critical roles from the development to manufacture of cell therapies, including cell isolation, cell modification/gene modification, cell expansion, cell banking, cell identification, and contamination testing.
For viral vectors and plasmid DNA development for gene therapy, dPCR offers significant advantages for quantification of target DNA molecules in a range of analytical assays necessary for viral vector production and characterization. Unlike qPCR, dPCR can provide an absolute count of nucleic acids, enabling the precise quantification of AAV vectors, bacterial contaminants, and residual host cell DNA. No reference standard is required, improving precision and removing a source of variation.
Vector construct identification
Viral titer measurement
Vector construct analysis
Residual plasmid DNA detection
Quantification and quality monitoring of stored DNA
Quantification of NGS libraries
Cell counting
Detection of microbial contamination
Residual host cell contamination
Confirmation of cell identity, modification, and characteristics
Viral titer measurement
Confirmation of cell identity and functional characteristics
Confirmation of transgene
Efficacy studies
Detection of microbial contamination
Residual host cell contamination
Viral titer measurement
Confirmation of product identity and characteristics