Choose qPCR and dPCR products by workflow or application
Central to maximizing the accuracy and efficiency of biologics development is working with a provider that offers a complete ecosystem of tools to robustly support both real-time PCR (qPCR) and digital PCR (dPCR) throughout your pipeline. With Applied Biosystems QualTrak real-time PCR and qPCR solutions for biopharma, Thermo Fisher provides an end-to-end ecosystem of innovative instrumentation, optimized assays and reagents, certified documentation, and world-class technical service and support. From early-stage discovery research to large-scale biomanufacturing, QualTrak qPCR and dPCR tools and solutions help enable flexible and scalable workflows for sensitive and specific quantitative nucleic acid analysis to optimize biopharmaceutical drug development and deliver quality products.
Explore QualTrak qPCR and dPCR tools and solutions tailored to a specific therapeutic modality, including cell and gene therapies, monoclonal antibodies, or vaccines. You can also explore recommended products based on common qPCR and dPCR applications.
Biologics—including vaccines, cell and gene therapies, monoclonal antibodies (mAbs), and their biosimilars—have great potential for the treatment and prophylaxis of a broad range of diseases. Help maximize the accuracy and efficiency developing biologics by working with a provider that offers an end-to-end ecosystem of qPCR and dPCR products for a range of applications—so you can leverage the right technologies at the right time.
A complete qPCR and dPCR ecosystem offers tremendous benefits for discovery, development, and manufacturing of vaccines, cell and gene therapies, and mAbs.
Our offering includes qPCR or dPCR products
for specific use-cases identified for common workflows within cell therapy, gene therapy, monoclonal antibody, or vaccine development.
Nucleic acid extraction is a critical step for downstream qPCR and dPCR analysis. While some types of analysis can be performed using crude lysate, most applications require high quality sample preparation free of contaminants and inhibitors. We offer products for different biochemical methods of purification with options for manual and time-saving automated workflows.
Reliably purifying high-quality DNA or RNA from biological samples helps ensure the highest levels of accuracy and sensitivity for qPCR and dPCR analysis.
Select a nucleic acid extraction product
by considering the throughput required, equipment available in the lab, or the degree of purity required.
In the context of biotherapeutic development, gene expression analysis is used to help identify and study genes that are significantly upregulated or downregulated in response to specific treatments or conditions. During discovery research, gene expression analysis is used to aid in the selection of suitable antigens, therapeutic targets, and biomarkers. Further down the pipeline, gene expression analysis plays an important role in efficacy and toxicity testing to help monitor therapeutic effects or potential adverse reactions.
Gene expression analysis supports the efficacy and safety of novel biotherapeutics by providing valuable insights during antigen and target identification, candidate characterization, and product testing.
qPCR is an established technology
for gene expression analysis, which requires consistent, linear amplification of targets across a wide range of concentrations. Our qPCR products are specifically formulated to efficiently detect targets at both high and low concentrations, with reagents optimized for both discovery research and post-discovery analysis and testing.
Copy number variation (CNV) analysis measures the number of sequence repeats for a specific genomic location with respect to a normal or reference genome. By analyzing CNVs, biotherapeutic drug developers can identify genomic alterations that potentially affect drug targets, drug metabolism pathways, or drug transport mechanisms. This information can guide the selection and design of drug candidates, helping to identify potential biomarkers associated with drug response or resistance.
CNV analysis plays a crucial role in biotherapeutic discovery and development by providing insights into the genomic alterations that can impact the effectiveness of potential therapeutic candidates
Choosing qPCR or dPCR for CNV analysis
depends on the particular use case. qPCR is a robust tool for standard CNV analysis looking at variants containing 0–5 genomic copies. However, dPCR enables higher precision and accuracy for quantifying small fold copy number changes or discriminating between complex somatic copy number variations.
SNP genotyping enables the detection and quantification of specific single nucleotide polymorphisms (SNPs) in a DNA sequence. By studying SNPs, researchers can identify specific genetic variations that may confer susceptibility to a particular disease or may affect drug targets, drug metabolism pathways, or drug transport mechanisms. This knowledge can guide the selection and design of novel therapies and enable the identification of potential biomarkers associated with drug response or resistance.
SNP genotyping enables insights into genetic variations that can inform the discovery of potential therapeutics and impact drug response and treatment outcomes.
With over 17 million TaqMan SNP assays
setting up high-throughput qPCR analysis is reliably simple. For ultra rare SNPs within a complex sample, you may also consider using dPCR for enhanced sensitivity and quantification.
Detection and quantification of nucleic acids has multiple critical use-cases across biologic drug development and manufacturing. During the development and maintenance of cell and virus banks, qPCR and dPCR enable reliable identity testing to confirm the presence genetic sequences. For viral vector purification and lot release testing, these tools are integral to precise quantification of genomic titer, viral particle titer, and full/empty capsid ratios. dPCR and qPCR are also used to measure vector copy number, which serves as a vital metric for determining therapeutic dose.
With the ability to precisely quantify nucleic acids, qPCR and dPCR are robust tools for reliably monitoring plasmid insertion, vector copy number, and viral titer.
Choosing between qPCR and dPCR
depends on the use case. For precise absolute quantification, such as capsid ratio determination, dPCR offers greater precision by removing variability associated with standard curve. dPCR also enables single-molecule resolution for multiple targets on a single plasmid. For quantification over a range of concentrations, including biodistribution studies, qPCR is an established and reliable tool.
Residual plasmid DNA testing and residual host DNA testing are integral to biotherapeutic development, helping ensure the safety and quality of products derived using genetic engineering processes. With the ability to detect and quantity nucleic acids with high levels of sensitivity, qPCR and dPCR are robust technologies to help test for residual plasmid DNA and host DNA throughout the biotherapeutic manufacturing process.
For biotherapeutics manufacturers, reliable residual plasmid and host DNA detection is critical to help meet safety and quality testing requirements by global regulatory agencies.
Streamline residual DNA testing
with a wide selection of custom and off-the shelf options for process and product-related impurity testing using qPCR or dPCR. Save valuable time with SEQ-technology qPCR and dPCR analytical testing solutions, featuring a fully integrated workflows from sample prep to analysis. Alternatively, select from our broad selection of assays and reagents to detect targets not covered by SEQ-solution kits.
Adventitious agents, which include various microorganisms like bacteria, viruses, fungi, mycoplasma, mycobacteria, and parasites, can unintentionally contaminate the manufacturing process of biological therapeutic agents. Detecting and addressing contamination early is a critical element of safe biologics manufacturing. Using qPCR or dPCR to test at multiple timepoints throughout the manufacturing process is a trusted and efficient way to maintain product safety and project timelines.
With the ability to quickly detect and quantify the presence of adventitious agents with high sensitivity and specificity, qPCR and dPCR can trigger timely responses to contamination events to help ensure product safety and uphold regulatory standards.
Our adventitious agent testing solutions
are designed to meet the unique needs of any development and manufacturing workflow. Applied Biosystems ViralSEQ and MycoSEQ detection systems offer total workflow solutions for the detection of common adventitious agents. For microbes not covered by SEQ kits, we offer custom and off-the-shelf qPCR and dPCR tools for rapid, ultra-sensitive microbial detection during biologics manufacturing.
MicroRNAs are small non-coding RNA molecules that control post-transcriptional gene expression of large subset of mRNA targets. miRNAs are central to the research and development of biotherapeutics with suggested utility as biomarkers, modulators of drug resistance, or as novel therapies.
Use qPCR to gain valuable insights into the potential roles of miRNAs as early biomarkers of disease or safety of novel therapeutics, modulators of drug efficacy, and as therapeutic candidates.
TaqMan Assays support miRNA research
from isolation through discovery, profiling, quantitation, validation, and functional analysis. With multiple choices and formats for detection of mature, biologically active miRNA, our qPCR tools enable a growing range of miRNA applications within biotherapeutic development.
For Research Use Only. Not for use in diagnostic procedures.