quality control

Scientists commonly use lentiviruses and adeno-associated viruses (AAVs) as viral vectors in cell and gene therapy (CGT) production. However, therapies that use these viruses must undergo strict quality control measures, including testing for replication-competent viruses (RCV), to ensure that the treatment is safe. Cell culture-based methods are currently the gold standard for RCV testing, but it can take up to 45 days for results to be returned. Droplet Digital PCR (ddPCR) kits now offer an attractive orthogonal method.

Methods that are highly accurate and precise provide the right answer, consistently. For digital PCR (dPCR), Poisson statistics dictate that the accuracy and precision of results are dependent on the accuracy and precision of sample partitions. This means that to get reliable dPCR results, you need to know your partition volume accurately and your partition volumes need to be consistent. See how our Droplet Digital PCR technology provides both accuracy and precision.

The therapeutic potential of messenger RNA (mRNA) therapeutics has an unprecedented ability to target previously undruggable diseases. The poly(A) tail drives the therapeutic efficacy of the mRNA molecule. Using Droplet Digital PCR (ddPCR) technology to analyze poly(A) tail length and integrity yields unrivaled sensitivity, enabling developers to ensure high poly(A) tail integrity and, ultimately, functional therapeutic mRNAs.

The realm of druggable targets has expanded significantly with the advent of mRNA therapeutics. Scientists require exceptional accuracy and confidence to adequately characterize these therapeutics and their anticipated effects. To this end, Droplet Digital PCR (ddPCR) technology has proven invaluable. With unparalleled precision and absolute quantification, Droplet Digital PCR is revolutionizing the field of mRNA therapeutic development and manufacturing.

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.

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.

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.