Droplet Digital PCR (ddPCR) provides highly precise, absolute quantification of nucleic acid sequences by counting nucleic acid molecules encapsulated in discrete, volumetrically defined water-in-oil droplet partitions. This digital measurement is suitable for the analysis of both, in-process samples and final drug products, due to the inhibitor tolerant nature of Droplet Digital PCR. This insensitivity to formulation matrices enables the implementation of Droplet Digital PCR throughout the entire manufacturing process. Bio-Rad’s ddPCR systems utilize a simple workflow with minimal hands-on time while reducing sample replicates and user-to-user variability.

– Installation qualification/operational qualification (IQ/OQ) service

– Premier service offerings with rapid on-site support

Developing effective and reproducible gene therapies requires the use of sensitive and robust testing methods, such as Droplet Digital PCR, to validate the quality of the therapeutic product. Bio-Rad’s portfolio of ddPCR Viral Quantification solutions offers an accurate, precise, and robust method to measure the viral titer in a sample. Customers may also use some of these solutions to perform quality checks on incoming plasmids and conduct biodistribution studies.

MOgene Droplet Digital PCR (ddPCR) Assays for AAV viral titer utilize the precision and sensitivity of ddPCR technology to deliver an absolute count of AAV vector genome copies in your sample. These assays can be ordered through the Cell and Gene Therapy Design Engine and come in two varieties:

– Custom ddPCR Cell and Gene Therapy Assays generated for target gene of interest

– Ready-to-order ddPCR Expert Design Assays for common viral vector and
plasmid elements

Development, validation, and implementation of robust and accurate methods are vital to test the safety and efficacy of gene-modified cell therapies, such as Chimeric Antigen Receptor T (CAR-T) cells. Droplet Digital PCR offers absolute quantification of transgene copy number in a sample. This method can be used to effectively quantify CAR copy numbers in transfected or transduced T cells or count the number of cells that contain the transgene of interest. This is especially important for transgenes that cannot be detected by antibodies. The ddPCR Whole Cell DNA Workflow is a reproducible and easy way to measure the percentage of edited cells with minimal input cells, which can be applied at multiple steps during the cell therapy manufacturing process.

OUR HISTORY SPEAKS FOR ITSELF