QualTrak qPCR & dPCR Biopharma Ecosystem Solutions

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.

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.

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.

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.

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.

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.

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.

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.