On This Page |
Introduction | Gene Therapy | CAR-T Cell Therapy | Contaminant Testing | Talk with a Specialist |
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.
Droplet Digital PCR is GMP-ready, designed to meet production and Quality Control (QC) environment needs:
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.
Bio-Rad's 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:
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 and can be applied at multiple steps during the cell therapy manufacturing process.
Purchase the Enhancer Reagent A to enable the ddPCR Whole Cell DNA Workflow and accurately count modified cells.
Learn about how Dr. Fehse uses ddPCR as a tool to monitor infused CAR-T cells in real-time using samples from patients.
Read about a novel digital PCR assay developed to monitor Tisa-Cel and Axi-cel CAR-T cells in patient samples.
Order the CD-19 CAR-T specific assay for the detection of Axi-cel or Tisa-cel transgene DNA as described in Dr. Fehse's research.
Cell lines and patient samples are prone to outbreaks of various mycoplasma infections; therefore, it is essential to address outbreaks as soon as they occur through robust testing. The Vericheck ddPCR Mycoplasma Detection Kit is a probe-based, highly sensitive and specific mycoplasma detection solution. This kit is designed and validated to meet European, U.S. and Japanese pharmacopoeia requirements. Detect up to 112 mycoplasma species using droplet digital PCR. Utilize the regulatory 21 CFR Part 11 compliant software to easily analyze and report your data.
The Vericheck ddPCR Mycoplasma Detection Kit is now available.
Residual DNA content is a common impurity in cell and gene therapy manufacturing, and levels must be carefully monitored for lot release. Droplet Digital PCR is a precise and sensitive method for direct quantitation of residual DNA content. Since Droplet Digital PCR does not rely on reaction efficiency for quantitation, it is less prone to sample interference from complex matrices and process intermediates.
Droplet Digital PCR provides a highly sensitive method for direct quantification of residual HCD to ensure adherence to the FDA guideline of <100 pg/dose.