Merck today launched its Droplet Digital Polymerase Chain Reaction (ddPCR) technology, a fully cGMP assay for titering viral products, including recombinant Adenovirus, Adeno-Associated Virus, Lentivirus and Retrovirus and other vectors used in cell and gene therapy development.
Merck’s BioReliance® Droplet Digital PCR Technology cGMP service is for cell and gene therapy developers who need a more robust assay for copy number determination. Providing copy number assessment and absolute quantitation, the new assay offers better precision and accuracy than traditional QPCR methods. It uses end-point Polymerase Chain Reaction (PCR) coupled with fluorescent technology for quantitation without the need for a standard curve, providing accurate and precise quantitation within the range of 10 to 10,000 copies/µL using Poisson statistics.
The reaction setup and droplet generation process is fully automated, resulting in a faster turn-around time. Positive and negative droplets are counted by the droplet reader to generate quantifiable results so there is no need to prepare assay standards. In addition, the high signal-to-noise ratio in individual droplets decreases potential PCR inhibition, which can often occur with quantitative PCR.
Merck provides the industry’s most comprehensive portfolio of high quality products, services and testing for biopharmaceutical manufacturing. The company’s BioReliance® services offers risk-mitigating approaches, testing, critical services and customized, complete solutions to help customers bring life-changing therapies to market.