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    20+ Years Of Bioanalysis
    700+ Small/Large Molecule Studies
    450+ Custom Bioanalytical Assays
    200+ Investigational Drugs
    1,000+ Biomarker & Cytokine Assays

    Which Real Time Quantitative qPCR Analysis And Digital ddPCR Assay Genomic Services Do We Offer?

    Real Time qPCR Analysis CRO And Digital ddPCR Assay Services To Accelerate Your Gene Expression, Biodistribution, Viral Shedding, Mutation Detection, Genetic Variation, And Genotyping Studies!

    Rapid and Reliable Gene Expression Using Real Time qPCR Assay or Multiplex dPCR Analysis

    • Deep expertise in custom-designed or pre-designed Real-Time qPCR assays in various biological matrices, including RNA isolates from tissues, cells, biofluids, and FFPE
    • Multiplex Digital dPCR gene expression study services to support mRNA or miRNA profiling and biomarker gene expression analysis

    Copy Number Variation (CNV) Assays Or Single Nucleotide Polymorphisms (SNP) Discrimination Analysis

    • Analysis of Copy Number Variation (CNV) by Relative Quantitation qPCR assays or Absolute Quantitation ddPCR analysis using tailor-made or off-the-shelf assays
    • Sensitive dPCR assays to detect and measure Rare Mutation Detection (RMD) or allelic discrimination for Single Nucleotide Polymorphism (SNP) assays

    Customized qPCR Services And ddPCR Assays for Cell and Gene Therapy (CAR-T) Applications

    • ddPCR analysis and qPCR assays for CAR T-cell pharmacokinetic (PK) and pharmacodynamic (PD) investigations
    • Residual DNA quantitation, Inserted gene copy number, or plasmid copy number analysis using ddPCR analysis and qPCR assays in viral seeds and cell banks

    Quantitative PCR / Digital PCR Assay Development, Optimization, Or Method Transfer

    • qPCR assays or ddPCR analysis for gene expression, miRNA profiling, copy number variation, rare target quantification, and SNP discrimination
    • ddPCR Gene Expression Service using customized or predesigned TaqMan or SyberGreen technologies

    Preclinical Or Clinical Vector qPCR/dPCR Based Biodistribution Sample Analysis

    • Determination of viral load through standard or custom assays for viral gene copy number analysis (qPCR assays or dPCR analysis), viral gene expression (qPCR assays or dPCR analysis)
    • Custom ddPCR assays for evaluating AAV, Lentivirus, Replication Competent Retrovirus (RCR) Replication Competent Lentiviruses (RCL) vector genome copy numbers in various tissues

    qPCR assay and ddPCR Method Validation and Sample Analysis

    • Method Validation/Qualification following GLP and MIQE guidelines using accredited equipment and reagents
    • High throughput sample preparation, nucleic acid purification, and quantification of genomic data in varied sample types through qPCR assays or ddPCR analysis

    Rely On Our Deep And Diverse Expertise With Real Time Quantitative qPCR Services And Digital ddPCR Services

    Custom TaqMan qPCR

    PD–Biomarker RNA Expression Profiling in NHP Tissues

    Multiplex Gene Expression

    Absolute Quantitation ddPCR Assay in RNA From Human Skin

    Copy Number Variation (CNV)

    Real-Time qPCR Genomic Gain/Loss Screening in DNA Isolates

    TaqMan SNP Genotyping

    qPCR Genomic DNA Allelic Variation in Human Whole Blood

    AAV Vector Biodistribution

    Tailored ddPCR Tissue-Level Gene-Therapy Copy Counts

    Lentiviral/Retroviral Integration

    ddPCR STR-Based CAR-T Integration Check

    HPV Viral Load Assay

    ddPCR Virus Titer Measurement in Human Whole Blood

    Residual Host Cell DNA

    ddPCR E. Coli, CHO, HEK293 Clearance In Drug Formulations

    Contact A Scientist With qPCR Service, ddPCR Service Need

    We Will Respond Within 1 Business Day

    Comprehensive Suite of Digital PCR (dPCR) Assay And Quantitative qPCR Services To Exceed Your Expectations

    Contact A Scientist For Real Time qPCR Service Or ddPCR Service

    We Will Respond Within 1 Business Day
    • We understand the critical nature of your qPCR analysis or dPCR assay projects. Do not allow your qPCR service provider bioanalysis lab to be the pitfall that delays the development of what could be the next world-leading drug in the market.
    • You are in the industry to make a difference. Having an extremely responsive and flexible bioanalytical laboratory at your disposal for qPCR assays and ddPCR quantification would tremendously expedite your drug development process.
    • You have a limited budget and tight timeline. That’s why sponsors trust our pre-established Real-Time qPCR and Absolute dPCR expertise to quickly advance their assay development and data generation. We have gained our deep assay troubleshooting experience from hundreds of such bioanalysis projects.

    20+

    Years of experience in designing, optimizing, and validating qPCR assays

    450+

    Custom Bioanalytical Methods Completed Within Budget

    Expected Services Turnaround

    We sincerely collaborate with you to achieve our common bioanalysis goals and speed up your qPCR assay or ddPCR analysis. Generally, we can do qPCR assay development and validate qPCR or ddPCR assays in six-to-eight weeks. Then, we can deliver audited documentation of GLP/MIQE/FFP qualification experiments in a few weeks. We have over 20 years of experience in designing, optimizing, and validating qPCR assays for biotech companies. So, we use our core strengths- operational excellence, regulatory expertise, and scientific experience to ensure your qPCR/ddPCR analysis is cost-effective and resource-efficient.

    Requested Sponsor Input

    Our team values clear communication between sponsors and our scientists, project managers, lab staff, etc. Could you please provide us additional introductory and background information about your analyte(s), preferred critical reagents, qPCR assay supplies, previous qPCR analysis data from experimental run(s), study protocols (with # of cohorts, samples), and any crucial ddPCR assay or RT-PCR analysis needs? All this information will help us accurately and efficiently define the scope of work for quotation and timeline estimation.

    We Are Grateful To Our Sponsors For Constantly Spreading The Word On Their Love Of Our Bioanalytical Lab Services!

    Head, Bioanalytical Development

    “NorthEast BioLab goes the extra mile. We look forward to more meaningful collaborations.”

    Sr. Dir., Bioanalytical Development & QC

    NorthEast BioLab offers a science-based, hands-on approach to the latest bioanalytical platforms

    VP, Bioanalytical Development

    “NorthEast BioLab is the most responsive and thorough bioanalysis lab services CRO.”

    VP, Development Operations

    NorthEast BioLab’s scientists deliver high-quality data on time and within budget

    VP, Biomarker Development 

    NorthEast BioLab is a responsive, collaborative, and reliable partner

    Executive Director, Pharmacokinetics

    We trust NorthEast BioLab to design and execute streamlined, impactful bioanalytical projects

    Contact A Scientist For Real Time qPCR Service Or ddPCR Service

    We Will Respond Within 1 Business Day

    Discuss Premier qPCR Assay Laboratory Services By Our Veteran Scientists To Accelerate Your Therapeutic Development, Today

    Custom qPCR and dPCR Assay Development

    • Tailored qPCR and dPCR assay development for gene quantitation, copy number variation, and SNP analysis.
    • Fast gene expression analysis using TaqMan assays and arrays for targeted pathways.
    • Optimized qPCR/ddPCR protocols for nucleic acid extraction, sample prep, and assay design.

    Expert qPCR and ddPCR Assay Services

    • Regulated molecular bioanalysis for gene expression and biodistribution studies.
    • Expertise in qPCR, qRT-PCR, and ddPCR for vector genome and therapeutic analysis.
    • GLP RT-qPCR for gene regulation through toxicological and metabolic biomarkers.

    Digital PCR Analysis Vs. Real Time Quantiative PCR (qPCR) For Multiplex Copy Number Variation Analysis

    Discover Digital PCR Analysis And Real-Time Quantitative PCR For Absolute Quantitation Of Genomic Alterations In Copy Number Variation Analysis …

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    Our Streamlined Process For On-Time Delivery Of Entire Scope Of Work Within Sponsor Budget

    customer
    Inquiry
    Fit
    Evaluation
    Preliminary
    Consulting
    Quotation
    Request
    Project
    Initiation
    Method
    Development
    Method
    Validation
    Sample
    Measurement
    Biomarker
    Evaluation
    Audited
    Report
    Next
    Steps

    Why choose us for your ddPCR assay or qPCR analysis?

    FDA Audited Bioanlaysis Lab qPCR CRO Offering qPCR Assay Development, Qalidation As Well As Agile ddPCR Analysis Services To Biotech Companies

    Contact A Scientist For Real Time qPCR Service Or ddPCR Service

    We Will Respond Within 1 Business Day
    • 20+ years of experience in multi-analyte and multiplexed qPCR workflows.
    • GLP/FFP validation for titer and residual DNA assays in process fluids and viral vectors.
    • Reliable partner for GLP qPCR analysis in preclinical and clinical studies.
    • Dedicated team supporting cell and gene therapies for safe and effective drug products.

    Support Your Drug Innovation With Entire Suite Of Bioanalytical Services In Safe Hands Of Our Veteran Scientists

    We Judiciously Invest In Our People, Solutions And Infrastructure, And Regularly Review Our Business Processes And Practices To Exceed Sponsor Expectations

    Pharmacokinetics (PK) Study

    Immunogenicity Testing

    Cytokine Analysis, Biomarker Assay

    Bioanalytical Assay

    Related FAQs

    Answers to additional qPCR Analysis, dPCR Assay questions popular among our potential sponsors.

    What is PCR?

    PCR stands for Polymerase Chain Reaction. This technique was first developed in the 1980s, and since then, it has been used to generate a large amount of DNA from a small DNA volume.

    PCR is a technique in itself. However, researchers often employ PCR in other processes, such as gel electrophoresis, DNA sequencing, and pathogen detection. PCR is fundamentally a diagnostic method used in different domains, including microbiology, virology, mycology, parasitology, and dentistry.

    PCR amplifies a specific section of DNA. The process begins with a DNA template. An enzyme, polymerase, copy this piece of DNA. The PCR reaction has a heating and cooling cycle. Researchers employ this cycle to separate the DNA strand and make multiple copies of the same strand. The final assay reaction thus contains a large number of identical DNA copies that researchers can use for further analysis, such as Southern blotting and sequencing.

    What is a qPCR assay?

    Quantitative PCR (qPCR) is similar to traditional PCR, but it can quantify the amount of DNA in the sample. qPCR analysis involves probes and fluorescent dyes that bind to the target DNA. These probes, when excited by a light source, emit different wavelength lights.

    Researchers measure the wavelength of each emitted light to determine the amount of target DNA present in the sample. Besides, one may monitor DNA amplification in the actual moment by determining the increase in fluorescence in real time.

    What is reverse transcriptase PCR?

    Reverse-transcriptase PCR (RT-PCR) is a PCR sub-type that generates cDNA from template mRNA molecules. RT-PCR can detect and quantify RNA viruses. The first step in RT-PCR analysis is reverse transcribing the mRNA template using reverse transcriptase enzyme. This cDNA is then amplified using PCR. RT-PCR is a sensitive and accurate technique to detect RNA viruses present at very low levels.

    qPCR can measure gene expression on its own. In qPCR expression analysis, a section of DNA is read to synthesize the mRNA, which then produces the protein of interest. However, in RT-PCR, reverse transcriptase creates cDNA, which is then used in PCR to calculate the mRNA transcripts.

    What is ddPCR analysis?

    Droplet Digital PCR (ddPCR) is an advanced version of qPCR and qRT PCR analysis. ddPCR gene expression can identify and amplify specific gene sequences for subsequent quantification. While qPCR has been a gold standard for evaluating gDNA and cDNA levels, it has limitations when it comes to assessing small differences in gene expression. ddPCR gene expression reduces these limitations by employing a partition in the traditional qPCR analysis. This ddPCR method divides a typical qPCR run into thousands of droplets. Each droplet is in the nanoliter range. Hence, ddPCR gene expression determines the target molecules based on Poisson Distribution. Such accurate analysis has made ddPCR gene expression the primary technique in the absolute quantitation of copy number variation and rare mutations.

    What is Digital PCR (dPCR) assay?

    Digital PCR (dPCR) assay is a novel technique for measuring and identifying nucleic acids that can quantify them precisely and detect rare variants. It works by dividing and isolating a DNA or RNA sample into many separate, parallel PCR reactions; some of these reactions have the target molecule (positive) and others do not (negative). Here, a single DNA or RNA molecule can be amplified by a factor of a million or more. During amplification, TaqMan® Assays with dye-labeled probes bind to specific sequences to identify targets. When the target sequence is absent, no signal is produced. After PCR analysis, the proportion of negative reactions is used to calculate the exact number of target molecules in the sample, without requiring standards or internal controls.

    What are the applications for Digital PCR (dPCR) analysis?

    Digital PCR analysis has many uses and is getting increasingly deployed to:

    • Determine the genetic makeup of an organism
    • Absolute quantification of DNA and RNA targets
    • Perform copy number analysis (CNV)
    • Detect rare mutations
    • Identify pathogens, their strains, and their viral load
    • Analyze proteins with assays that use proximity ligation

    How does Digital PCR (dPCR) compare to ddPCR analysis?

    Some differentiating features of the QuantStudio™ Absolute Q™ Digital PCR dPCR System include:

    • 90-minute turnaround time for quick answers
    • ≥95% sample utilization, <5% dead volume to enable accurate quantitation
    • Ease of use—complete one hands-on step with an entire plate in less than 5 minutes; no rolling or sticky seals
    • Flexibility to run 4, 8, 12, or 16 samples per plate, saving consumables and lab resources
    • Image subtraction allows debris and defects to be subtracted during analysis to improve calling accuracy for rare target

    What are the differences between PCR and qPCR analysis?

    The primary difference between the two methods is that qPCR measures in real-time. This real-time feature means researchers can monitor target DNA amplification as it is happening.

    Secondly, qPCR employs probes or fluorescent dyes. These probes quantify the total amount of target DNA present in the study sample.

    Finally, the main function of PCR analysis is to amplify DNA and help in other downstream applications. On the other hand, qPCR is employed widely to detect and quantify RNA viruses.

    What do qPCR assays measure?

    In gene expression analysis, qPCR assays can determine the amount of mRNA present in the sample. A small mRNA region is amplified, while the qPCR tool measures the intensity of individual probes. As the number of cycles increases, the fluorescent signals increase with an increase in amplicons.

    The Ct value represents the primary qPCR experience. The threshold in qPCR analysis is in the linear phase, and the curve crossing the threshold is the measured Ct value. The threshold value is unique for each qPCR assay.

    The primary principle of qPCR analysis is that at each assay cycle, the PCR products double in number. Often, qPCR analysis gives a relative expression, which varies in the gene expression of the assay sample. Researchers may also determine the absolute quantification of a gene. However, absolute quantification requires a standard, which is generally the cloning of cDNA into a vector.

    What Is Absolute Vs Relative Quantification In QPCR?

    Real Time-PCR/qPCR quantification can be absolute or relative. Absolute quantitation determines unknown samples by interpolating their copy number relative to those obtained from a standard curve. Absolute quantitation may be used to study the correlation between viral or gene copy numbers and disease state. It is important to understand the exact copy number of the target RNA in a biological sample to be able to study the progress of the disease. Relative quantitation is used to analyze how the activity of genes in a sample is increased or decreased relative to a reference, control sample that has a normal or baseline gene activity. Relative quantitation is used for comparisons of healthy and diseased subjects, for determining genetic or phenotype related differences between samples., or to compare disease or disease treatment sample biomarkers to baseline levels. Both methods involve normalization of gene quantitation by simultaneous or parallel measurement of a housekeeping gene (for eg. beta actin or GAPDH) – the expression levels of which are relatively stable and are not altered by disease state or treatment. This ensures that differences in absolute or relative level of the gene changes observed are from disease state or treatment and not from differences in nucleic acid loading.

    What are the two basic approaches to qPCR analysis?

    There are two approaches to qPCR analysis: dye-based and probe-based. Let us dive deep into each of these qPCR types.

    Dye-based qPCR assays

    This method measures the fluorescent signals, specifically the binding of the dye to the double-stranded DNA. Initially, the dye shows a weak signal. However, after binding to the double-stranded DNA, the signal increases dramatically. Hence, target sequence amplification increases the fluorescence, which directly relates to the amount of double-stranded DNA in the sample. This approach needs only two primers specific to the sequence. Hence, dye-based qPCR is a rapid way to assess a large number of study samples.

    However, dye-based methods can detect all double-stranded DNA present in the sample. This non-specific detection can include primer dimers and non-specific products, leading to inaccurate results. Hence, reaction specificity is verified using the denaturing/melting curve after each qPCR run. Such an approach ensures that only the target DNA is amplified. Moreover, another limitation of this approach is that dye-based qPCR can only quantify one target sequence at a time.

    Probe-based qPCR analysis

    Probe-based qPCR measures the fluorescent signal of sequence-specific fluorophore-labeled probes. This method is more specific than a dye-based approach and hence is preferred in diagnostic applications.

    Probe-based qPCR is a multiplexed method that can quantify multiple targets in a single sample reaction. This multiplexing approach employs a specific fluorophore for each target. Probe designs vary among experiments. However, hydrolysis probes are most commonly used in probe-based qPCR.

    What are the applications of qPCR assays?

    qPCR is a rapid and sensitive tool for the accurate determination of nucleic acids in diverse biological samples. Their applications include cancer phenotyping, gene expression analysis, and the detection of GMOs in food.

    In research capacities, qPCR can provide quantitative analysis of gene copy numbers and the presence of mutant genes. Besides, qPCR can be combined with RT-PCR to quantitate alterations in gene expression. For example, researchers can monitor changes in mRNA levels to assess the effect of drugs and environmental conditions on gene expression levels.

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