Bioanalysis Solutions
Bioanalysis
Optimized bioanalytical solutions for
pipeline development
Synexa has a global reputation for large molecule bioanalysis, providing expert insights and reputable data to world leaders in drug development.
- Synexa was founded to support the global biopharmaceutical industry with bespoke end-to-end bioanalytical solutions in order to effectively achieve their clinical milestones, supporting the development of a wide range of therapeutics from discovery through phase IV.
- We have a deep base of experience and expertise in standardised and de novo development, validation and production of pharmacokinetic and immunogenicity assays for Biosimilars, BioBetters and New Biological Entities (NBE’s).
- We pride ourselves in identifying, implementing and integrating the optimum analytical methodologies for Biosimilars, BioBetters and all other therapeutic drug pipelines.
Services
Overview
Large molecule bioanalysis
Assessment of the immunogenicity of therapeutic drugs becomes particularly important when considering the significance of anti-drug antibodies (ADA) in clinical studies.
Our customizable panel of assays are developed through thorough method development and validation to ensure the assays meet regulatory and sponsor-specific requirements, and provide useful, clinically-relevant data to facilitate the progression of your therapeutic pipeline.
PK/PD assays
Our PK/PD assays are well recognized for their sensitivity and specificity, custom developed and validated according to your requirements. Our assays are compatible with sample material from an extensive array of matrices and are thus suitable for large-scale, high-throughput clinical studies.
All assays are developed by our expert scientific teams, in collaboration and close consultation with your scientists. Our years of practical expertise ensures that development, optimisation and validation are of the highest quality.
Custom solutions & Novel modalities
As the medical field advances, promising novel therapeutic targets and drug modalities are regularly under investigation, requiring highly specific, high quality scientific research expertise.
At Synexa, we specialize in providing bespoke assay development, validation and production, providing quality results, customised to your specific requirements. Our scientists have unrivalled experience in the investigation of novel drug modalities and the development of custom assays to meet and resolve the key clinical endpoints under investigation.
Other capabilities include:
- Dose response, safety and efficacy
- MSD discovery assays
- Chemiluminescence assays
- Receptor occupancy assays
- Analysis in a wide range of biological matrices
We use innovative, industry-proven and trusted technology platforms to ensure we provide only best data for your purpose.
