Signatope

SignaXENO is a specialised range of assays designed to evaluate the potential of substances to induce enzymes and transporters involved in drug metabolism, particularly the quantification of Cytochrome P450 enzymes. Unlike traditional methods that rely on mRNA profiling, SignaXENO utilises protein-based assays, as protein levels have a higher predictive value for enzyme activity than mRNA levels.

The SignaXENO assays can measure hundreds of samples per week, requiring less than 20 μg of human hepatocyte material. This efficiency marks a 50-fold improvement in sample throughput and tissue usage compared to other methods, representing a significant leap forward in the field.

SignaXENO is designed to unambiguously identify and quantify CYP isoforms through mass spectrometry, which is more selective and precise than CYP probes that often lack isoform specificity. The workflow is streamlined to require only a small amount of sample, facilitating the analysis of numerous samples swiftly, a stark contrast to the slower and more resource-intensive targeted proteomics approaches.

Fully compliant with FDA bioanalytical method validation guidelines, SignaXENO guarantees data integrity for regulatory review. Researchers and developers can rely on SignaXENO as the most robust, efficient, and precise solution for conducting drug metabolism studies. Currently Signatope has established assays for Cytochrome P450 isoforms 1A1, 1A2, 2B6, 2C8, 2C9, 2C18, 2C19, 2E1, 2D6, 3A4, 3A5, 3A7 and CPR.

Custom Assay & Antibody Development

Signatope provides specialised custom assay and antibody development services tailored to the needs of its clients under the SignaXIM trademark. To date, Signatope has successfully created over 150 unique antibodies targeting short terminal epitopes. This achievement enables the enrichment of myriad peptides within a single species’ digested proteome. The synergy between Signatope’s proprietary antibodies and the exceptional sensitivity and specificity of mass spectrometry facilitates swift assay development.

In addition, Signatope excels in delivering distinctive monoclonal and polyclonal antibody development services, which are integral for mass spectrometry-based immunoassays, such as ImmunoMALDI. The company’s innovative approach includes unparalleled epitope selection tools, affinity screening techniques, and clone selection based on slow dissociation rates (k_off), coupled with sophisticated antibody purification processes and array-based epitope characterisation methodologies, ensuring unparalleled success rates in their field.

Advancing Drug Safety and Biomarker Analysis

Signatope’s innovative technology combines the precision of immunoenrichment with the accuracy of mass spectrometry, facilitating the measurement of a wide array of biomarkers across different species and a game-changer for drug safety analysis.

The company has revolutionised the production of specific monoclonal antibodies with its TXP antibodies, which recognise terminal sequences of just four amino acids. This enables the binding to peptides with these sequences and their identification via mass spectrometry, thus expediting assay development. Their extensive library, encompassing over 6,000 proteins, drastically reduces the time required to develop custom assays for targeted biomarkers.

Moreover, Signatope’s SIGNAture epiTOPE technology identifies conserved signature epitopes within biomarker sequences, consistent across species and protein isoforms. These epitopes act as biomarker proxies, allowing for multi-species detection with a single antibody ensuring consistent data. This breakthrough has slashed custom assay development times to as little as two months, provided the target analyte is in Signatope’s antibody library.