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Advance your cell and gene therapies with real-time PCR technologies

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. 

QualTrak cell and gene therapy workflow

The QualTrak cell and gene therapy workflow includes qPCR use cases across all steps of the development pipeline from discovery to GMP manufacturing.

Absolute Q Viral Titer dPCR assays

Absolute Q Viral Titer Digital PCR (dPCR) assays offer a precise, fast, and simple solution for accurate, absolute quantification of viral vectors in cell and gene therapy. 

Compliance documentation

QualTrak cGMP-compliant assays and reagents include quick and easy  access to documentation.


QualTrak workflow

qPCR use-cases in mRNA and protein-based cell and gene therapy pipelines

Discovery

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 

Process development

Detection of microbial contamination 

Residual host cell contamination 

Confirmation of cell identity, modification,  and characteristics 

Viral titer measurement 

Pre-clinical and clinical trials

Confirmation of cell identity and functional characteristics 

Confirmation of transgene 

Efficacy studies 

cGMP manufacturing

Detection of microbial contamination 

Residual host cell contamination 

Viral titer measurement

Confirmation of product identity and characteristics 


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