A Bioanalytical CRO You Can Trust from Discovery to Post-Market
With a legacy built on quality, trust, and scientific precision, our large molecule bioanalysis team thrives on tackling regulatory challenges and development roadblocks from early discovery through post-market studies. We leverage advanced platforms like ELISA, MSD, Gyros and ddPCR to support your success and deliver reliable data and high-touch client experiences. Whether designing new assays or accelerating pathways to approval, we prioritize innovation and progress, transforming challenges into milestones.
Comprehensive Bioanalytical Services
Method Development & Validation Services
Customized solutions for complex therapeutic modalities, including biologics, vaccines, and biosimilars
.jpg?lang=en-US)
Pharmacokinetic (PK) & Toxicokinetic (TK) Studies
Accurately quantify drug concentrations and assess safety profiles with novel methodologies
.jpg?lang=en-US)
Immunogenicity Testing
Gain insights into potential immune responses triggered by biologic drugs at all development stages
.jpg?lang=en-US)
Biomarker Services
Detect and quantify biologic markers to understand a drugs mechanism of action, its efficacy, and potential adverse effects
.jpg?lang=en-US)
Molecular Biology
Leverage molecular assays, such as RT-PCR and ddPCR, to unlock the full potential of your next generation therapy
Assays Platforms
PK/TK – Ligand Binding Assay - Single analyte - ELISA - Gyrolab
- Ultra - sensitive - Singulex - Quanterix
- Single & multiplex - MSD
Immunogenicity – ADA Assay - ELISA - Gyrolab
- MSD - Envision
- Flow Cytometry
Biomarkers - ELISA - Gyrolab
- MSD - Envision
- Flow Cytometry
Bioassays - Master Cell Bank - Working Cell Bank
- Functional Assays: Neutralizing anti-drug antibodies, evaluation of proliferation or cell death, reporter gene assays, and enzyme activity
Learn How We Can Support Your Program ►
Guided by Expertise, Backed by Quality Data
- Thoughtful, objective guidance at every stage of development
- Innovative solutions tailored to your project’s specific challenges
- Long-term relationships grounded in loyalty, wisdom, and commitment to your goals
- Adherence to GLP, GCP, and CLIA standards ensuring the highest level of accuracy and compliance
- Personalized services and transparent communication throughout the project lifecycle
- Expertise in numerous therapeutic areas and large molecule modalities
Large Molecule Bioanalytical Services
FAQs
What is bioanalytical method validation?
- Bioanalytical validation proves that the optimized method developed is acceptable for the analysis of biological study samples and evaluates accuracy, precision, recovery, and stability.
What bioanalytical services does Smithers offer?
- Smithers provides comprehensive bioanalytical testing services, including pharmacokinetic (PK) and toxicokinetic (TK) studies, immunogenicity testing (anti-drug antibodies and neutralizing antibodies), biomarker analysis, and molecular assays. We support biologics, monoclonal antibodies, biosimilars, gene therapies, vaccines, and other therapeutic modalities.
How does Smithers ensure the quality of its testing services?
- Smithers adheres to GLP, GCP, and CLIA certifications, ensuring compliance with global regulatory guidelines. Our quality assurance processes include risk management, continuous improvement, and employee training to uphold rigorous standards for reliable and reproducible data.
What technology platforms are utilized by Smithers for bioanalysis?
- At Smithers, we employ advanced platforms such as ELISA, MSD (single and multiplex), Singulex, Gyrolab, Quanterix, ddPCR, and RT-PCR. These state-of-the-art technologies ensure high sensitivity, specificity, and accuracy.