Understanding the PK profile of a given therapeutic is essential to assess its efficacy and safety. PK evaluations help define the proper dosage, route, and administration schedule during preclinical and clinical studies. Reliable bioanalytical laboratories should provide PK assay development, validation, and sample testing, as well as PK analysis and reports to support all drug modalities at any phase of development.
Immunogenicity refers to the ability of novel therapeutics to stimulate an immune response in the human or animal body, specifically, the development of antidrug antibodies (ADAs). The neutralizing fraction of ADA (NAb) may affect the product’s efficacy and potentially threaten patient safety. The measurement of adverse immune reactions is complex as it depends on many drug, target, patient, and disease-specific aspects.
How are qPCR Services crucial in drug development?
Biomarkers (biological markers) have evolved into pivotal components of drug discovery and development. Historically, biomarkers primarily comprised proteins/peptides and metabolites quantified through technologies like immunoassays, enzymatic assays, HPLC, and mass spectrometry. However, the advent of PCR-based technologies, notably qPCR expression analysis, and the widespread adoption of microarray-based experimentation in recent years have introduced a fresh array of DNA- and RNA-based biomarkers. These advancements offer promising avenues for leveraging biomarkers in drug discovery and development endeavors.
What are the current and emerging technologies available in the qPCR field?
In addition to traditional PCR methods, such as digital PCR analysis, modern PCR services incorporate advanced techniques like qPCR assays. The qPCR technology available to researchers today boasts enhanced sensitivity, speed, and affordability compared to its initial introduction. This revolutionary technology has transformed detection capabilities across all realms of molecular biology. While the fundamental principles of qPCR have remained unchanged since its inception, continuous advancements and modifications have significantly improved its overall performance. These enhancements span from alterations in the enzymatic reaction cocktail components to innovations in detection systems, including instrumentation and software.
Copy number analysis in qPCR
When employing qPCR to assess alterations in DNA copy numbers, two pivotal factors emerge the performance of the qPCR assay and the dependable normalization of DNA input. Hence, the method for analyzing copy number variation (CNV analysis) necessitates employing a CNV assay capable of providing precise, accurate, reproducible, and easily interpretable detection of CNVs. Quantitative PCR (qPCR) has been instrumental in scrutinizing gene expression and quantifying copy number variations through real-time PCR. This method entails amplifying a test locus with an unknown copy number alongside a reference locus with a known copy number.
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What is the difference between qPCR and qRT-PCR:
RT-PCR employs reverse transcription to generate a DNA template from an RNA source, which can subsequently undergo amplification. Unlike PCR and RT-PCR, which are generally endpoint reactions, qPCR and RT-qPCR analyze the kinetics of product synthesis rates during the PCR process to quantify the amount of template present precisely.
In the realm of drug development, pharmacokinetics, and immunogenicity testing stand as indispensable components. Among the myriad techniques aiding these endeavors, qPCR emerges as a crucial tool. Its application extends across pharmacokinetics and immunogenicity testing, significantly enhancing the efficacy and precision of these critical processes.
