On This Page |
Impurity Testing with ddPCR Technology | Quantify HEK293 Residual DNA | Size HEK293 Residual DNA | Detect Mycoplasma | Resources |
Confidently Conduct Impurity Testing for Gene Therapy
Harness the power of ddPCR™ technology for accurate and precise detection and quantification of host cell DNA and pathogenic microbes.
Sensitive, Accurate, and Precise Impurity Testing Using ddPCR Technology
Detecting potentially harmful contaminants left behind by gene therapy manufacturing workflows is a critical QC function. However, finding sensitive and ready-to-use methods for detecting and quantifying host cell DNA and pathogenic microbes in gene therapy batches can be challenging. Without methods that can quickly deliver reliable results, you may end up increasing production costs by continuing to produce contaminated lots or, in the case of false positives, you might unnecessarily delay production when a lot is actually within specifications. Fortunately, Bio-Rad offers ready-to-use and custom Droplet Digital™ PCR (ddPCR™) assays for impurity testing that expedite your gene therapy manufacturing processes.
Did you know?
ddPCR instruments and assays from Bio-Rad are robust enough to meet the needs of QC environments.
Learn More »
Detect HEK293 Residual DNA
With many gene therapy viral vectors manufactured in HEK293 cells, accurate and precise quantification of residual HEK293 DNA is essential for producing a safe therapeutic. 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 »
-
Introduction to Droplet Digital PCR: Workflow and Applications
This webinar introduces the concept, workflow, and performance of Droplet Digital PCR and highlights the diverse applications showcased in recent journal publications.
-
Introduction to Digital PCR
Discover the basics and fundamentals of digital PCR technology in our Learning Center.
Size HEK293 Residual DNA
Verify that any HEK293 residual DNA in your gene therapy preparations 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 »
Increase Throughput with the QX ONE ddPCR System
The QX ONE ddPCR System is designed to offer walk-away nucleic acid quantification. The system fully automates the ddPCR workflow, from droplet generation to nucleic acid amplification to droplet reading. The QX ONE System has multiplex capabilities with 4 channels that enable processing of 480 samples without user intervention.
Test for Mycoplasma Contamination
When choosing the proper 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 Bio-Rad’s 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 »
QX ONE Droplet Digital PCR System Tour
The QX ONE ddPCR System seamlessly integrates a standard ddPCR workflow of droplet generation, thermal cycling, droplet reading, and analysis into a hands-free precision platform.
Resources
Documents
-
Regulatory Expectations and Guidelines Around AAV Gene Therapy
Gain insights into regulatory considerations for AAV-based gene therapies from industry thought leaders in cell and gene therapy.
-
Tips for Meeting Regulatory Guidelines for AAV Development
Find tips on meeting regulatory guidance for gene therapies from industry experts in cell and gene therapy.
-
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.
-
Quality Control Solutions for Cell And Gene Therapy
Discover our comprehensive portfolio of ddPCR solutions for cell and gene therapy applications.
-
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 Gene Therapy Development Solutions
-
Gene Therapy Development Overview
Bring efficiency to your workflows and confidence to your decision making with our gene therapy manufacturing products.
-
Viral Titer Determination
Switch to ddPCR for viral titer determination or upgrade to an easy-to-use, high-performance ddPCR platform for your gene therapy workflows.
-
Viral Vector Characterization
Enable efficient and accurate characterization of your viral vector with our full workflow of products, whether your gene therapy uses AAV or another vector technology.