Residual Host Cell DNA Quantitation Solutions

resDNASEQ Residual Host Cell DNA Quantitation System

The Applied Biosystems resDNASEQ Host Cell DNA Quantitation system offers a fully integrated, sample-to-answer solution available for either real-time or digital PCR. Both technology platforms employ an easy-to-implement and simple-to-use workflow that helps deliver accurate and actionable results in just a few hours.

  • Confidence in results: Highly specific and accurate quantitation
  • Regulatory compliant: Designed to help meet regulatory guidelines of the FDA, WHO, EMA and other regulatory agencies
  • Reliable and consistence performance: Kit-to-kit, lot-to-lot, and year-to-year
  • Worldwide adoption: Widely adopted for routine use in major global biopharma companies
  • Global support network: Supported throughout the validation process by our regulatory and field application specialists

Comparing real-time and digital PCR technologies

Video: What's the difference between qPCR and dPCR?

 

 

Fast Facts: High-performance analytical solutions for residual DNA testing in cell and gene therapy using qPCR or dPCR technologies

Infographic: Comparing real-time and digital PCR technologies

 

 

Streamlined workflow—from sample preparation to analysis in less than 5 hours

The end-to-end resDNASEQ solution is comprised of complementary sample preparation optimized for resDNASEQ kits, comprehensive assays complete with reagents and DNA standards*, widely used Applied Biosystems instruments, and integrated analysis software that simplifies your data output. Additionally, there are automation solutions to enable throughput flexibility. Whatever your workflow and application needs, we have a system that is right for you.

 

Get consistent performance regardless of sample matrix complexity

Our Applied Biosystems PrepSEQ kits for residual host cell DNA sample preparation are a magnetic bead based nucleic extraction and purification workflow, with best-in-class recovery efficiency for applications where consistent absolute quantitation and highest sensitivity detection are required. Easy to follow protocols for both manual and automated workflows are available based on your process needs.

 

Increase sample processing throughput

The KingFisher Apex magnetic particle processor instrument offers an easy workflow with high throughput so you can process up to 96 samples with about 1 hour of total hands-on time using PrepSEQ sample preparation kits.

  • Consistent, high-quality nucleic acid recovery from a wide variety of sample types
  • Validated nucleic acid purification method for the resDNASEQ workflow to enable consistent, reproducible results
  • Cross-contamination control leveraging the bead transfer technology

Leverage the kit designed for your cell line of choice

We offer an extensive portfolio of Applied Biosystems resDNASEQ Residual Host Cell DNA Kits covering most of the common cell lines used in biotherapeutic development. ResDNASEQ kits are known for their outstanding quality and performance. As a result, they have become a trusted and widely adopted solution for routine use at major biopharma companies.


 

Power your quantitation with industry-leading instruments

The Applied Biosystems QuantStudio 5 system is designed for both new and experienced users who need simple and affordable real-time PCR systems without compromising performance and quality.
 

An established qPCR workhorse, the Applied Biosystems 7500 Fast Real-Time PCR System is a powerful platform for labs requiring reliable performance with minimum investment.


 

The Applied Biosystems QuantStudio Absolute Q Digital PCR System, powered by proprietary microfluidic array plate (MAP) technology, enables all the necessary steps for dPCR on a single instrument.

 

Simplify data analysis with integrated instrument and analysis software

The Applied Biosystems AccuSEQ Real-Time PCR Detection Software addresses the unique needs of analytical testing of residual host cell DNA during the biopharmaceutical manufacturing process. Next-generation algorithms offer accurate quantitation data for resDNASEQ residual DNA analysis and allow for easy sample concentration determinations with relevant statistics.

  • Interfaces with the Applied Biosystems QuantStudio 5 and 7500 Fast Real-Time PCR instruments
  • Intuitive interface to set up sample runs and interpret impurity data
  • Security, audit, and e-signature capabilities to help enable 21 CFR Pt 11 compliance
  • Windows 10 compatible

Analytical Method and QC Testing Strategies for Biologics Production

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No matter your questions, we are here to help. Our experienced team of scientists and technical specialists is ready to assist you in choosing the right solution and products. Complete this form to start the conversation.
 

 

Analytics Knowledge Hub


Explore the Analytics Knowledge Hub from Thermo Fisher Scientific, providing a robust collection of webinars, articles, eBooks, infographics, and other digital resources to help you optimize the use of our products in your bioprocess workflow.
 

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