Advanced CYP450 Metabolism Assays 

SignaXENO^TM is an advanced range of CYP450 metabolism assays developed for assessing the potential of substances to activate drug metabolism-related enzymes and transporters, focusing on Cytochrome P450 enzymes.

The proprietary SignaXENO^TM range uses protein-based assays instead of mRNA profiling, as protein levels more accurately predict enzyme activity. Capable of processing hundreds of samples weekly with less than 20 μg of human hepatocyte material, it offers a 50-fold increase in efficiency over traditional methods.

Advanced CYP450 Metabolism Assays 

Signatope’s SignaXENO^TM range of advanced assays for Cytochrome P450 (CYP450) enzymes provide a vital tool for drug metabolism studies. These enzymes play a crucial role in metabolising various drugs and xenobiotics. Unlike mRNA quantification, which often leads to false-positive findings and unnecessary drug-drug interaction (DDI) studies, protein levels reflect enzyme activity more accurately. Signatope’s assays ensure precise, isoform-specific protein quantification, which directly correlates with enzyme activity and offers reliable results for drug metabolism and interaction studies.

Accurate Identification and Quantification of CYP450 Isoforms

Signatope employs a proprietary technology that combines motif-specific antibodies with mass spectrometry readout. This innovative approach allows for the accurate identification and quantification of CYP450 isoforms, which is critical given the lack of isoform specificity in many traditional CYP probes. The technology’s high sensitivity enables the detection of low-abundance CYP enzymes in complex biological samples, such as tissues, cell pellets, or lysates. This ensures that even minute amounts of CYP proteins can be accurately quantified, providing robust and reliable data.

Efficient and High-Throughput Workflow

Signatope’s workflow is designed for efficiency and scalability. The process requires minimal sample amounts, such as those from a 96-well cell culture plate, and allows for the analysis of hundreds of samples within a week. This high-throughput capability significantly outpaces standard targeted proteomics approaches. The batch processing concept includes calibration curves for CYP450 isoforms and biological quality control samples, ensuring that the results are absolute, reliable, and reproducible. This makes Signatope’s SignaXENO assays ideal for large-scale studies and routine analysis.

Rigorous Validation Ensuring Compliant and Reliable Results

SignaXENO^TM assays are extensively validated according to FDA guidelines for bioanalytical method validation. This rigorous validation ensures reliable and reproducible results across various sample types, including tissues and cells. Parameters such as intra-assay and inter-assay precision, accuracy, and total error are thoroughly tested, meeting stringent acceptance criteria. This validation process guarantees that the data generated by these assays are robust and suitable for supporting regulatory submissions.

Accurate Quantification of CYP450 Enzymes for In Vitro Drug Interaction Studies

The accurate quantification of CYP450 enzymes is essential for in vitro drug interaction studies during drug development. Signatope’s assays provide detailed protein expression data that reflect enzyme function, thus avoiding the pitfalls of mRNA quantification. In studies with human cryopreserved hepatocytes treated with different compounds, the assays demonstrated precise quantification of CYP1A2, CYP2B6, CYP2C8, CYP2C9, and CYP3A4. This data is crucial for assessing the induction potential of investigational drugs, thereby enhancing the understanding of their metabolic profiles and interaction risks.

Expert Support and Comprehensive Guidance

Signatope offers expert support and guidance throughout the quantification process. Their team of experienced scientists assists with experimental design, sample preparation, and data analysis, ensuring that clients obtain meaningful and interpretable results. This support is particularly valuable for those new to CYP enzyme quantification or requiring assistance in optimising their experimental workflow. The provided sample requirements, including minimal protein amounts and specific storage and shipping conditions, ensure the integrity and quality of the samples for accurate analysis.

Proven Technology Backed by Scientific Research

The efficacy and reliability of Signatope’s assays are supported by extensive scientific literature. Studies have demonstrated the precision and accuracy of these assays in various applications, such as direct quantification of cytochromes P450 and drug transporters, and analysis of hepatic cytochrome P450 expression across species. These publications highlight the robustness and applicability of Signatope’s technology in both research and clinical settings, ensuring confidence in the results obtained.

CYP450 Isoform Analysis Benefits for Drug Development and Clinical Research

Signatope’s CYP450 isoform analysis offers significant benefits for drug development and clinical research. The high specificity and sensitivity of these assays enhance the detection of enzyme induction and inhibition, crucial for understanding drug metabolism and potential interactions. The efficient, high-throughput workflow reduces time and costs associated with large-scale studies. Rigorous validation ensures that the data are reliable and suitable for regulatory submissions, facilitating smoother approval processes. The comprehensive support provided by Signatope’s experts ensures that clients can fully leverage the capabilities of these advanced assays, ultimately contributing to safer and more effective drug development.

For more information, please contact Signatope via the Quick Contact Forms or email: info@signatope.com