Precise Cell and Gene Therapy Potency Quantification
Inadequate quality control assays shouldn’t limit cell and gene therapy applications. Instead, quantifying the potency of cell and gene therapies is essential for successful therapeutics. In this article, we describe multiple leading potency assays developed using Droplet Digital PCR (ddPCR) technology, including an assay that quantifies transgene integration and expression in one step.
Top 5 Takeaways from ddPCR World 2021
Precision diagnostics for cancer. COVID-19 surveillance in wastewater. Quality control of cell and gene therapies. These were just a few of the cutting-edge applications on display at the Droplet Digital PCR (ddPCR) World 2021 symposium. Recapping the event in 5 takeaways, moderator Francisco Bizouarn shares how international experts are leveraging ddPCR technology to solve today’s scientific and public health problems.
With Cell and Gene Therapies, Success and Quality Control Go Hand-in-Hand
While the FDA has approved Abecma, the first CAR-T cell therapy in its class, regulatory approval is just the beginning for cell and gene therapies. Such therapies’ safety and financial viability rest on a robust manufacturing and quality control program with the flexibility to scale up and out. Droplet Digital PCR is a sensitive biopharmaceutical quality control tool, offering absolute quantification of nucleic acids and other molecules in a sample.