QualTrak qPCR & dPCR Biopharma Ecosystem Technologies

Effectively integrate qPCR and dPCR into your bioanalysis

As powerful tools for quantitative nucleic acid analysis, both real-time PCR (qPCR) and digital PCR (dPCR) play a critical role in the discovery, development, and manufacture of biotherapeutics. Integrating qPCR and dPCR into your bioanalysis workflows imbues your process and product with enhanced reliability by enabling precise molecular insights for discovery and characterization through quality control and release testing. With application support ranging from gene expression and genetic variation analysis to transgene quantification and contamination testing, the Qualtrak qPCR and dPCR ecosystem provides the tools and services you need to help streamline workflows and simplify compliance.

 

While both qPCR and dPCR use similar fluorescent probe-based technology to quantify nucleic acid targets, key differences in quantification methods confer each tool with application-dependent benefits or limitations. Even in a single lab, there are often separate use cases for both qPCR and dPCR. We recommend choosing the best technology for each use case by considering absolute quantification necessity, target concentration, total sample number, and user preference.

Real-time PCR for discovery-stage research

qPCR is a well-established and reliable tool that measures nucleic acid target amplification against a reference for each PCR cycle, enabling analysis based on reaction kinetics. Because qPCR measures target amplification against a reference, it is often used for relative quantification. qPCR can also be used for absolute quantitation of targets but requires a standard curve of known reference concentration. Compared to dPCR, qPCR has the wider dynamic range, spanning approximately ten orders of magnitude. As a powerful tool for monitoring targets across a wide range of concentrations, qPCR is also capable of detecting down to a 1.5-fold change in target quantity.

For discovery-stage research, qPCR helps enable identification and screening of potential targets or therapeutic candidates via molecular interrogation of processes related to pathogen and disease biology. Thermo Fisher offers a comprehensive and integrated set of qPCR products for discovery research, empowering you to accelerate your investigations, generate reliable data, and contribute to the development of innovative biotherapeutic solutions. QuantStudio real-time instruments, TaqMan probe-based assays, and TaqMan master mixes work seamlessly together, providing a complete qPCR solution that simplifies experimental design to help save time and resources.

QuantStudio real-time PCR systems

QuantStudio real-time PCR instruments are advanced platforms that help enable reliable and reproducible results while offering user-friendly software, flexible throughput capabilities, and robust performance. With the QuantStudio 5 and QuantStudio 7 Pro instruments, researchers are empowered to choose the system that best meets their needs to facilitate the discovery of novel biotherapeutics.

TaqMan probe-based qPCR assays

Our proprietary qPCR assay design pipeline supports over 21 million predesigned assays, custom assays, and individual custom primers and probes for a range of applications, enabling researchers to accurately quantify nucleic acids or detect genetic alterations. TaqMan real-time PCR assays offer exceptional sensitivity, specificity, and dynamic range, reducing assay optimization time and accelerating the research process.

TaqMan qPCR and RT-qPCR master mixes

TaqMan real-time PCR master mixes are optimized formulations that enhance the sensitivity and efficiency of qPCR reactions. These qPCR master mixes contain all the necessary components for successful real-time PCR, helping to ensure reproducibility and minimizing experimental variability to help researchers streamline workflows and achieve accurate and consistent results in biotherapeutic discovery research.

Real-time PCR for post-discovery analysis and QC testing

qPCR is a valuable tool in the development and production of biotherapeutics, providing critical information that can help ensure product safety, efficacy, and consistency. During process development, real-time PCR is used detect and quantify nucleic acid sequences to establish quality control specifications and monitor genetic identity and conformity. In subsequent pre-clinical and clinical research, qPCR can be used to determine the pharmacokinetics and pharmacodynamics or monitor subject response to a potential biotherapeutic. qPCR is also routinely used to help maintain consistency and stability during manufacturing and can be used during quality control testing to detect any potential contamination or deviations, allowing for prompt corrective actions to be taken.

Our Qualtrak qPCR portfolio offers a comprehensive solution for post-discovery biologic development and manufacturing. Designed to support cGMP-compliant workflows, the Qualtrak qPCR ecosystem includes high-quality TaqPath qPCR reagents and assays backed by strong quality management systems and enhanced compliance documentation for ongoing regulatory support. QuantStudio qPCR instruments enable high-throughput, user-friendly, and automation-ready qPCR workflows that help improve consistency and speed by reducing error-prone manual tasks and making 24/7 operations possible. QualTrak qPCR tools for post-discovery analysis are optimized to help fast-track your biologics manufacturing by maximizing uptime and workflow efficiency.

QuantStudio 7 Pro Real-Time PCR System

The QuantStudio 7 Pro Real-Time PCR System offers an enhanced user experience and enables automation to accelerate development timelines. Increase throughput and flexibility with interchangeable blocks, while maintaining exceptional reproducibility with minimal well-to-well and instrument-to-instrument variability. QuantStudio 7 Pro systems also include software features to supports compliance with 21 CFR Part 11 FDA guidelines on electronic records security for ultimate traceability.

TaqPath probe-based qPCR assays

Ideal for post-discovery qPCR applications, TaqPath assays offer comprehensive documentation and enhanced compliance standards to enable traceability and reproducibility. When moving forward with a candidate, transition to TaqPath assays to help ensure consistency and quality during analysis. All TaqPath assays are manufactured according to principles of GMP for easy implementation into your process development, QC, clinical testing, and manufacturing workflows.

TaqPath qPCR and RT-qPCR master mixes

Post-discovery biopharma processes require real-time PCR reagents with the highest level of consistency and reliability. With stringent cGMP manufacturing, excellent performance, and compliance documentation support, TaqPath general purpose reagents are designed to deliver confidence and reliability for even your most demanding applications. TaqPath master mixes are labeled “For Laboratory Use” and optimized for exceptional lot-to-lot consistency.

dPCR for absolute quantification and rare target detection

dPCR is a leading technology for the detection and quantification of rare mutations and nucleic acid sequences. dPCR works by dividing a bulk PCR reaction into thousands of microchambers, each containing zero, one, or just a few DNA molecules. Absolute target quantity is determined by applying Poisson statistics to the total number of positive and negative microchambers based on endpoint fluorescent signals, negating the need for a standard curve. By removing variability associated with standard curve quantification, dPCR offers greater precision for absolute quantification than qPCR, especially for low-level targets. Further, single-molecule interrogation enables identification and quantification of molecules containing multiple targets such as engineered plasmids.

With the ability to provide an absolute count of nucleic acid targets, dPCR is used in applications throughout biotherapeutic development and manufacturing, including vector copy number assessment, genomic titer, capsid ratio determination, and residual DNA testing. To help optimize dPCR workflows, the QuantStudio digital PCR system leverages our proprietary microfluidic array plate (MAP) technology to offer accuracy and consistency for absolute quantification. MAP technology offers significant benefits over droplet digital PCR (ddPCR) including reduced dead volume to help ensure maximum sensitivity. The simple workflow with fast time-to-answer helps enable reliable quantitative bioanalysis backed by our TaqMan Assay portfolio.

QuantStudio Absolute Q Digital PCR System

Overcome challenges with other ddPCR and dPCR platforms and leverage the full power of dPCR with the QuantStudio Absolute Q Digital PCR System. Powered by proprietary MAP technology, the QuantStudio Absolute Q system enables all the necessary steps for dPCR—compartmentalizing, thermal cycling, and data acquisition—to be conducted on a single instrument. The simple workflow improves ease of use, minimizes hands on steps, and provides results in as little as 90 minutes.

Microfluidic array plates

Some emulsion-based or ddPCR technologies suffer from a lack of consistency due to variable compartmentalization of the reaction. QuantStudio Absolute Q MAP technology  does not use droplet generation or a physical displacement of excess reagents to form compartments This enables superior consistency, reduced reagent waste, and a simplified workflow to provide overall greater volume precision, higher numbers of microchambers generated, and more accurate quantification.

Absolute Q digital PCR assays

Predesigned Absolute Q dPCR assays consist of a forward primer, one or more target-specific probes, and a reverse primer pre-mixed together at specified concentrations. They require no further design, optimization, or verification, and are based on the same TaqMan qPCR probe chemistry cited in more than 200K research publications. The proprietary probes feature a minor groove binder (MGB) moiety at the 3’ end, enabling better sequence discrimination and flexibility to accommodate more targets in a single reaction.

Automated qPCR and dPCR for high-throughput analysis

Automation of qPCR and dPCR workflows have revolutionized the field of bioanalysis, significantly improving the speed and efficiency of biotherapeutic development and manufacturing. By streamlining sample processing and downstream analysis, these technologies help reduce human error, increase throughput, enhance data accuracy, and improve reproducibility. The integration of automated sample preparation with high-throughput qPCR and dPCR provides researchers and manufacturers with valuable tools to accelerate the development and production of safe and effective biotherapeutic products.

Our QualTrak ecosystem of qPCR and dPCR tools includes high-throughput, user-friendly, and automation-ready instrumentation that helps provide consistency and speed by reducing error-prone manual tasks and making 24/7 operations possible. With automation technologies that support smarter end-to-end workflows, you can minimize hands-on time with and maximize throughput with KingFisher sample purification systems, QuantStudio 7 Pro real-time PCR systems, and the QuantStudio Absolute Q Digital PCR Suite.

KingFisher sample purification systems

KingFisher purification instruments automate the extraction and purification of DNA and RNA for downstream real-time PCR and dPCR analysis. Increase yield reproducibility with easy-to-follow protocols that remove manual steps and reduce overall processing time while avoiding errors associated with manual sample preparation. Samples processed with KingFisher instruments maintain consistent results across runs and different users, which is crucial for more sensitive downstream genetic analysis.

QuantStudio 7 Pro Real-Time PCR System with Orbitor RS2 Microplate Mover

The Orbitor RS2 Microplate Mover is a benchtop mover designed for use with QuantStudio 7 Pro real-time PCR systems, enabling qPCR in automated environments for increased sample throughput. The flexible, easy-to-use Orbitor RS2 Microplate Mover provides improved process efficiency with its innovative bidirectional telescoping arm and expansive 360° workspace. The integrated barcode reader enables sample tracking, barcode transmission, and inventory management for enhanced productivity.

QuantStudio Absolute Q AutoRun Suite

The QuantStudio Absolute Q AutoRun Digital PCR Suite offers flexible configurations and walk-away workflows, allowing you save time and resources while maximizing throughput with dPCR. This integrated system solution is designed to scale precise nucleic acid quantification while maintaining simplicity. With highly precise standard curve–free absolute quantification, our automated dPCR analysis minimizes variability and optimizes throughput during sample characterization and testing.

For Research Use Only. Not for use in diagnostic procedures.