Bioanalysis Services
Bioanalytical laboratory CRO solutions to progress your clinical research pipelines
Bioanalytical Solutions for Clinical Trials
With over two decades of experience, Synexa is a bioanalytical CRO operating at the forefront of scientific innovation, offering a wide range of bioanalytical solutions, including mass spectrometry (LC‑MS/MS), immunoassays, radiopharmaceutical bioanalysis, and custom assay development to support small and large molecule drug development.
Our integrated bioanalysis services span the full drug development lifecycle, from discovery and preclinical through to clinical phases, providing comprehensive PK, TK and PD analysis, immunogenicity assessment, and assay development. We generate robust, accurate, and regulatory-ready data to accelerate and de-risk your therapeutic pipeline.
Bioanalytical Services
Mass Spectrometry
Precise, sensitive quantification of small and large molecules using mass spectrometry platforms to support robust pharmacokinetic and biomarker analysis.
Immunoassay Services
Radiopharmaceutical Bioanalysis
Specialised radiopharmaceutical bioanalysis solutions enabling accurate measurement of radiolabelled compounds, delivering critical comprehensive insights into biodistribution, pharmacokinetics, and safety profiles.
Biosimilars
Support biosimilar development with bioanalytical, immunogenicity, and PK services, delivering robust comparability data to demonstrate safety, efficacy, and regulatory confidence.
Bioanalytical Assays
Immunogenicity Testing
Assessing the immunogenicity of therapeutic drugs is particularly important when considering the significance of anti-drug antibodies (ADA) in clinical studies. Our customisable assay panels are developed through rigorous method development and validation to ensure regulatory and sponsor-specific requirements are met, whilst simultaneously providing useful, clinically relevant data to facilitate the progression of your therapeutic pipeline.
Pharmacodynamic (PD) Assays
Our PD assays, renowned for their sensitivity and specificity, are custom-developed and validated by our expert scientists, in collaboration with your team and according to your requirements. Assays are compatible with sample material from an extensive array of matrices and therefore are suitable for large-scale, high-throughput clinical bioanalysis studies.
Pharmacokinetic (PK) and Toxicokinetic (TK) Assays
Synexa’s comprehensive Pharmacokinetic (PK)/Toxicokinetic (TK) bioanalytical services meticulously assess absorption, distribution, metabolism, excretion and kinetics of toxic substances. Our expertise ensures that customers receive crucial insights, optimising drug safety and efficacy for successful therapeutic development.
Regulatory Expertise
Our Experts Help You Navigate Complex Regulatory Requirements
Synexa supports pharmaceutical and biotechnology companies with regulated bioanalytical services aligned with global quality and compliance standards. Our GCP/GLP-certified and GCLP-accredited labs follow internationally recognised guidelines, including those of the FDA, EMA, MHRA, and ICH, and are supported by robust quality systems. Our facilities are regularly inspected by leading regulatory authorities, including the MHRA and FDA. We also welcome client audits and inspections, reinforcing our commitment to transparency, integrity, and delivering reliable, high-quality data.
20+
Years of helping customers to navigate the complex and ever-evolving regulatory landscape
Bioanalytical Platforms
Our technology platforms are robust, reliable and widely used across the clinical field, providing comprehensive and detailed data readouts. Below is a selection of core platforms; our bioanalytical platforms and capabilities extend beyond these to support a broad range of applications.
Waters T-QS LC-MS/MS
Tandem mass spectrometry system for sensitive, quantitative small molecule bioanalysis
Sciex 6500+
Triple quadrupole mass spectrometer for highly sensitive, quantitative bioanalysis
Waters Premier I-Class UPLC
Ultra-performance liquid chromatography system delivering high-resolution compound separation
MSD SQ 120
Compact MSD reader enabling robust electrochemiluminescent immunoassays
WIZARD2 gammacounter
Gamma counter for sensitive radioisotope detection in ligand binding and PK assays
Biacore T200 GxP SPR
Label-free surface plasmon resonance system for real-time biomolecular interaction and binding kinetics analysis
Envision Xcite
Multimode plate reader supporting luminescence, fluorescence and absorbance-based bioassays
Gyrolab xPlore
Automated nanolitre-scale immunoassay platform for rapid, low-volume protein biomarker analysis
FAQ
Can Synexa develop custom bioanalytical assays for complex studies?
Yes. Synexa specialises in designing and validating bespoke assays tailored to your therapeutic and study requirements. Our scientists leverage advanced platforms and innovative strategies to overcome challenges such as assay interference and matrix effects.
What bioanalytical platforms does Synexa use for assay development?
Synexa leverages advanced analytical platforms, including LC-MS/MS, MSD electrochemiluminescence, ELISA, AlphaLISA, DELFIA, luminescence, fluorescence/FRET, and Gyrolab. These technologies enable us to deliver sensitive, robust, and custom-designed assays tailored to your study requirements.
How does Synexa ensure the accuracy and reliability of bioanalytical assays?
All Synexa assays undergo rigorous validation following the latest regulatory guidelines. Key parameters include precision, accuracy, selectivity, specificity, stability, and drug tolerance. This meticulous approach guarantees high-quality, reproducible data for pharmacokinetics, immunogenicity, and pharmacodynamic studies.
What makes Synexa a trusted partner for regulated bioanalysis services?
Synexa Life Sciences brings over 20 years of expertise in developing and validating complex bioanalytical assays for large molecules, including monoclonal antibodies, bispecifics, and peptides. Our assays are designed to meet FDA and EMA guidelines, ensuring precision, accuracy, and regulatory compliance at every stage of clinical development.
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