Addressing regulatory guidance for HEK293 cells & AAV-based therapeutics manufacturing

Testing and characterization in cell and gene therapy manufacturing is critical for AAV-based therapeutics. Regulatory guidance affecting those using HEK293 cells or AAV-based therapeutics is evolving over time, especially pertaining to quantitating residual host cell DNA and analyzing its size via E1A fragments, quantitating residual plasmid DNA (pDNA), and detecting the presence of the E1A oncogene. Integrated solutions leveraging real-time PCR or dPCR technologies are necessary to meet regulatory needs. 

This article will cover some of the latest regulations around residual DNA amounts in the product, as well as quantitating host cell and pDNA, and the presence and size of the E1A oncogene. Integrated dPCR and qPCR assay solutions will also be introduced.

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