Regulated Bioanalysis Services
Regulated bioanalytical solutions to progress your clinical research pipelines
Regulated Bioanalytical Solutions for Clinical Endpoints
With over two decades of experience, our bioanalytical laboratory strives to be at the forefront of scientific innovation, housing the tools and expertise required for successful compound development and market release.
Our large and small molecule bioanalytical services seamlessly integrate into your discovery, preclinical, and clinical phase development, delivering robust, accurate and reliable data endpoints to advance your therapeutic pipelines.
Bioanalytical Laboratory Services
Immunogenicity Assessment
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 provide useful, clinically relevant data to facilitate the progression of your therapeutic pipeline.
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.
PK/TK Analysis
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.
Biosimilar Development
Synexa’s specialised bioanalytical labs, deep regulatory expertise and technical proficiencies make us the ideal partner for biosimilar therapeutic development. We tailor our services to each project, encompassing bioequivalence studies, anti-drug antibody (ADA) assessments and more. With a history of successful collaborations in clinical bioanalysis, we work closely with customers to navigate the complexities of biosimilar development while meeting stringent timelines and regulatory standards.
Bioanalysis Platforms
Our technology platforms are robust, reliable and reputable in the clinical field and provide comprehensive and detailed data readouts for your application.
VICTOR® Nivo™
Waters T-QS LC-MS/MS
Sciex 6500+
Waters Premier I-Class UPLC
BD FacsLyric (12 colours)
MSD S600
MSD SQ 120
Olink Signature q100
WIZARD2 gammacounter
Biacore T200 GxP SPR
Envision Xcite
Gyrolab xPlore
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.
Bridging the gap between science and life.
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