Protein quantification for biomarker analysis, pharmacodynamics, and target engagement studies is performed using Biognosys’ TrueSignature platform or SISCAPA immuno-enrichment to enable ultra-sensitive readouts and is available for both research use and fully GCP-compliant clinical applications.
Biognosys’ Clinical and Targeted Proteomics provides quantitative protein measurements to support decision‑making across all stages of drug development. The offering is designed to translate protein data into robust, reproducible endpoints for biomarker analysis, pharmacodynamics, and target engagement studies.
The TrueSignature platform is compatible with GCP‑compliant workflows and enables multiplexed quantification of up to 50 proteins per assay with absolute, peptide‑level accuracy. As the approach is antibody‑free, it avoids cross‑reactivity and supports high reproducibility across studies.
For ultra‑low abundance targets, SISCAPA immuno‑enrichment extends sensitivity into the low pg/mL to fg/mL range, enabling absolute concentration reporting of critical biomarkers in plasma, serum, CSF, and other biological matrices. Biognosys supports the full process, from assay design and validation to clinical sample measurement.
Proteomics Service / Clinical Targeted Proteomics
Proteomics Service / Clinical Targeted Proteomics
Proteomics Service / Clinical Targeted Proteomics
Ultra‑high sensitivity down to fg/mL levels on par with established ligand-binding assays, delivered with short turnaround times.
Protein detection at single amino acid resolution enabling quantification of isoforms, splice variants, PTMs and drug-derived labels.
Cross-species and matrix compatibility enabling robust measurements across biofluids, solid tissues, and FFPE specimens.
Multiplexing with fully customized panels up to 50 proteins in a single run without interference.
Fit-for-purpose validation and GCP-compliant analysis delivering decision-ready clinical biomarker insights.
1. Assay Design & Panel Scoping
Target list review, feasibility assessment, and panel configuration aligned to your clinical question and matrix.
2. Peptide Selection & Standards
Proteotypic peptide selection and synthesis of stable isotope‑labeled reference standards through third party provider.
3. Automated Sample Prep
Standardized sample digestion with optional SISCAPA immuno-enrichment for ultra‑low concentration targets.
4. Targeted MS Measurement
High resolution Parallel Reaction Monitoring (PRM) for single- or multiplex assays with reference peptides as internal standards.
5. Data Delivery & Reporting
Absolute quantification results addressing different levels of validation needs: Exploratory, fit-for-purpose, or GCP-compliant and audit‑ready.
Proteomics Service
Biognosys’ Targeted Proteomics Assays provide reliable, quantitative measurement of low‑abundance protein biomarkers for clinical and translational research. All assay formats deliver multiplexed, peptide‑level quantification with high selectivity, precision, and reproducibility, enabling robust biomarker endpoints across drug development.
Our customizable assays provide an attractive solution for situations where established methods are unavailable or insufficient. They are applicable across a wide range of biological matrices, including plasma, serum, CSF, PBMCs, and tissue samples, and support cross‑species measurements where required.
All assay formats follow the same standardized workflow, including peptide selection, assay development, targeted MS detection, quality control, and data analysis. SISCAPA immuno‑enrichment integrates seamlessly into this workflow and provides an option for highest sensitivity, extending quantification into the low pg/mL to fg/mL range for ultra‑low abundance targets.
Proteomics Service
Fit‑for‑purpose assay validation is essential for the reliable use of clinical samples and for generating biomarker data that are suitable for decision‑making. Properly validated assays ensure that protein measurements are accurate, precise, reproducible, and appropriate for their intended use, enabling confident interpretation of pharmacodynamic and target‑engagement endpoints.
Biognosys’ Assay Validation for Clinical Trials service provides fit‑for‑purpose validation of multiplexed targeted proteomics assays, aligned with applicable regulatory guidelines and the specific requirements of each clinical development program. Validation strategies are defined according to the biomarker Context of Use (CoU) and focus on performance characteristics relevant to the study objectives, such as accuracy, precision, sensitivity, selectivity, and sample stability.
Each project begins with an upfront validation plan that defines the validation scope, study design, and experimental approach. All activities are conducted within GCP‑compliant workflows, generating high‑quality, audit‑ready data with full supporting documentation. Upon completion, a formal validation report is issued, documenting assay performance and confirming suitability for use in clinical sample analysis and downstream decision‑making.
Proteomics Service
SISCAPA (Stable Isotope Standards and Capture by Anti‑Peptide Antibodies) enables ultra‑sensitive, quantitative measurement of low‑abundance protein targets that are below the detection limits of standard targeted mass spectrometry. Following proteolytic digestion, proprietary antibodies selectively enrich peptides of interest, reducing matrix interference and increasing analytical sensitivity. Combined with high‑resolution mass spectrometry, this approach delivers reproducible, MS‑based quantification with sensitivity reaching the low pg/mL to fg/mL range.
SISCAPA assays are well suited for biomarker programs requiring high sensitivity and specificity, including low‑abundance pharmacodynamic markers and target engagement studies such as targeted protein degradation. The platform supports measurements in complex biological matrices such as plasma, serum, CSF, and tissue, and is applicable across therapeutic areas including oncology, cardiology, inflammation, infectious diseases, and metabolic disorders.
Through Biognosys’ exclusive collaboration with SISCAPA Assay Technologies, clients access an integrated, end‑to‑end offering that spans assay design, antibody reagent generation, fit‑for‑purpose validation, and GCP‑ready clinical sample analysis. Services are available as fully custom assays or through a growing portfolio of off‑the‑shelf SISCAPA assays and reagents. All activities are delivered within standardized, quality‑controlled workflows, providing a single contract research partner from development through clinical application.
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