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Leverage ddPCR for QC | Ensure Viral Vector Purity | Quantify Transgene Copy Number | Detect Microbial Pathogens | Resources |
Count on Bio-Rad for Assays to Help Ensure Manufacturing Quality and Safety
Efficiently ensure the safety of your cell therapy manufacturing process, whether you are evaluating transgene copy number or verifying the absence of microbial pathogens.
Leveraging the Speed and Sensitivity of ddPCR™ Technology for Cell Therapy Manufacturing
When it comes to quality control (QC) lot release assays, you need easy-to-implement, high-throughput assays that you can have the utmost confidence in. For detecting impurities such as microbial pathogens, you also need sensitivity.
With Droplet Digital™ PCR (ddPCR™) technology, you can have it all — easy-to-use plate-based instruments that deliver quantitative accuracy, sensitivity, and reproducibility.
Did you know?
ddPCR instruments and assays from Bio-Rad are robust enough to meet the needs of QC environments. Learn More
Ensure Viral Vector Purity Before Treating Cells
Detect HEK293 Residual DNA
With many viral vectors manufactured in HEK293 cells, accurate and precise quantification of residual HEK293 DNA is essential for producing a safe transgene delivery vector. However, the standard methods used for such quantification, like qPCR, face challenges due to lack of specificity and reproducibility. The Vericheck ddPCR HEK293 Residual DNA Quantification Kit, with a novel 5-plex ddPCR assay, has been designed to quantify residual HEK293 DNA in biotherapeutics with high specificity and reproducibility, without the need for reference curves.
- Achieve high sensitivity and specificity
- Move quickly with an easy, extraction-free protocol
- Efficiently meet regulatory requirements
Learn More and Order the Vericheck ddPCR HEK293 Residual DNA Quantification Kit »
Bio-Rad instruments and software for ddPCR technology meet Good Manufacturing Practice (GMP) regulations and QC environments and comply with U.S. FDA 21 CFR Part 11 regulations.
Our compliance with International Organization for Standardization (ISO) extends beyond ISO 9001 to ISO 13485 and includes stringent documentation requirements and product-specific demands.
Size HEK293 Residual DNA
Verify that any HEK293 residual DNA in your transgene delivery vectors is below the FDA-recommended size of 200 base pairs with the Vericheck ddPCR HEK293 Sizing Kit. This kit is the first HEK293-specific ddPCR based residual DNA sizing solution that has been designed and validated to meet regulatory guidance requirements and is capable of measuring HEK293 size without the use of reference curves.
- Achieve high sensitivity and specificity
- Move quickly with an easy, extraction-free protocol
- Efficiently meet regulatory requirements
Learn More and Order the Vericheck ddPCR HEK293 Residual DNA Size Kit »
Efficiently Quantify Transgene Copy Number
Turn the ddPCR assay you developed for quantifying transgene copy number into a robust cell therapy manufacturing QC lot-release tool to ensure quality and standardized potency.
With ddPCR technology, quantification does not depend on amplification efficiency but instead uses endpoint PCR to deliver absolute measurement. The process starts by isolating individual transgenes from your sample into discrete, volumetrically defined droplet partitions. Then, inside each partition, the nucleic acid is amplified if the transgene is present. Quantification is determined by calculating the ratio of transgene-positive partitions to transgene-negative partitions.
Transgene measurement with ddPCR technology is precise and accurate, and with our family of ddPCR instruments, straightforward to learn and implement.
Featured Publications
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Application of Droplet Digital PCR for the Detection of Vector Copy Number in Clinical CAR/TCR T-Cell Products
Discover how ddPCR technology is a robust tool for accurate quantitation of average vector copy number in CAR and TCR-engineered T cells.
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Digital Droplet PCR for Quantification of CD19-Directed CAR T Cell
Learn how this novel ddPCR assay allows for monitoring of CAR T cells in vivo and may add to safety and efficacy of CAR T-cell treatment.
Test for Mycoplasma Contamination
When choosing an appropriate Mycoplasma detection method, researchers need to consider sensitivity and turnaround time. Traditional culture-based detection tests, for instance, can take up to 28 days to deliver results and often produce false positives.
ddPCR detection, on the other hand, provides high sensitivity with a quantitative readout that reports both in genome copies (GC) per reaction and colony-forming units (CFU) in less than one day. The ddPCR technology also demonstrates high reproducibility across operators, instruments, lots, and days.
Perform quality control analysis to detect Mycoplasma contamination with our probe based Vericheck ddPCR Mycoplasma Detection Kit. The high sensitivity and specificity of this kit allow for precise measurements of 112 mycoplasma species using ddPCR.
Learn More and Order the Vericheck ddPCR Mycoplasma Detection Kit »
Resources
Publications
Application of Droplet Digital PCR for the Detection of Vector Copy Number in Clinical CAR/TCR T Cell Products
Lu A, et al. J Transl Med. 2020; 18: 191.
Digital-Droplet PCR for Quantification of CD19-Directed CAR T-Cells
Mika T, et al., Front Mol Biosci. 2020; 7: 84.
Documents
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Transitioning from Quantitative PCR to Droplet Digital PCR for Mycoplasma Detection
Review strategies for overcoming challenges, developing robust methods, and advancing your viral vector manufacturing processes.
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Quality Control Solutions for Cell and Gene Therapy
Discover our comprehensive portfolio of ddPCR solutions for cell and gene therapy applications.
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Vericheck ddPCR HEK293 Residual DNA Sizing Kit
Discover the HEK293 specific ddPCR-based sizing solution, capable of measuring HEK293 without the use of reference curves and designed and validated to meet regulatory guidance requirements.
Discover More Cell Therapy Development Solutions
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Cell Therapy Development Overview
Creating standardized treatments from inherently variable material like living cells requires knowing exactly what you are working with, whether in discovery, development, or manufacturing. Bio-Rad is here to help.
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Antigen Discovery
Discover innovative cell therapy approaches quickly and confidently with automated and quantitative tools for neoantigen discovery, CAR T-cell characterization, CAR construct optimization, and more.
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Characterization
Develop critical assays to evaluate potency and batch-to-batch consistency, whether for CAR T-cell characterization or development of another cell therapy approach.
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In Vivo Bioanalysis
Assess the body’s reaction to your cell therapy by developing in vivo bioanalysis assays to monitor CAR T-cell persistence, exhaustion, and other functional parameters.