Clinical Bioanalysis
Partner with an expert team that provides global clinical study support for small molecule, large molecule and innovator drugs. Our clinical bioanalysis services cover the full range of development needs, helping advance your compound more efficiently and effectively.
Clinical Bioanalytical Studies
to Support Global Clinical Trials
Our clinical bioanalytical team brings decades of experience advancing both small and large molecule compounds through global clinical trials. As an end-to-end partner, we use insights from discovery and preclinical bioanalysis to eliminate the need to transfer a compound from one unit to another, significantly reducing timelines.
- 3,000+ Global clinical trials
- 120+ R&D drug products supported
- 390+ clinical biomarkers for small and large molecules
- 60,000 samples per month capacity
- 20,000 square feet of GLP lab space
- State-of-the-art mass spectrometry platforms with UHPLC-MS/MS capabilities
- Automated and semi-automated high-throughput-capable systems including Janus®, TomTec® CyBio®-SELMA
- 21 CFR Part 11-compliant validated systems; Analyst®, MassLynx™, Watson LIMS™
Small & Large Molecule Clinical Bioanalysis
We offer robust bioanalytical method validation for clinical studies in accordance with regulatory guidelines, ensuring reliable and consistent results, for both generic/biosimilar and innovator drugs. Our clinical study support services cover a wide range of samples and techniques.
Clinical Study Support Services
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Sample management
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Clinical pharmacokinetics (PK) sample analysis
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Radiolabeled hAME sample analysis
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Clinical metabolite ID and (radio) profiling: 3H and 14C
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MIST cross-species metabolite comparison
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14C-labeled and 19F-NMR mass balance
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Soluble, genetic, cellular and tissue biomarker analysis
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Analytical Techniques
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LC-MS/MS
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Ligand Binding
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Whole blood count
Urinalysis
Chemistry
Basic immunology
Coagulation
Safety Laboratory Tests for Clinical Bioanalysis
We provide comprehensive safety laboratory testing to monitor the health of participants throughout clinical trials. By closely tracking key biological markers, we help identify potential risks early, ensuring participant safety and the success of your study.
Sample Management for Clinical Studies
In addition to providing expert clinical bioanalytical services, we manage all aspects of sample management, including storage, transport, and material management to ensure sample integrity throughout the study.
Frequently Asked Questions
What is clinical bioanalysis?
In clinical bioanalysis, drugs, metabolites, and biomarkers in biological samples collected from clinical trials are quantitatively measured. This is essential for evaluating drug candidates’ pharmacokinetics, pharmacodynamics and therapeutic effectiveness in humans.
Why is clinical bioanalysis important?
Clinical bioanalysis is crucial for understanding how a drug functions in the human body. This data is essential for establishing correct dosages, comprehending drug interactions, monitoring therapeutic levels and guaranteeing patient safety.
What types of samples are analyzed in clinical bioanalysis?
Typical samples for clinical bioanalysis include blood, plasma, serum, urine, saliva, and tissue biopsies. These samples are examined to determine the levels of drugs, metabolites, and biomarkers.
What analytical techniques are used in clinical bioanalysis?
Frequently employed techniques in clinical bioanalysis include liquid chromatography-mass spectrometry (LC-MS), gas chromatography-mass spectrometry (GC-MS) and a variety of immunoassay methods, such as enzyme-linked immunosorbent assays (ELISA). These methods offer high sensitivity and specificity in detecting analytes.
How are bioanalytical methods validated for clinical studies?
Bioanalytical methods for clinical studies undergo validation in accordance with regulatory guidelines to guarantee accuracy, precision, sensitivity, specificity, reproducibility and robustness. This validation ensures the production of reliable and consistent results from the methods.
What regulatory guidelines govern clinical bioanalysis?
Clinical bioanalysis must adhere to regulatory guidelines set forth by international regulatory bodies. These guidelines establish the criteria for method validation, sample analysis and data reporting.
Can customized bioanalytical services be provided for specific clinical trials?
Yes, specialized bioanalytical services can be customized to accommodate the specific requirements of various clinical trials. This encompasses developing and validating distinctive analytical methods to address particular research inquiries.
How long does it typically take to complete a clinical bioanalysis study?
The length of a clinical bioanalysis study is determined by the project’s complexity, the number of samples and the necessary analytical methods. Timelines are typically established and approved during the project planning phase.
What types of clinical bioanalysis services does WuXi AppTec provide?
We offer clinical bioanalysis for small and large molecules using LC-MS/MS and Ligand Binding platforms, supporting generic/biosimilar and innovator drugs.
How does WuXi AppTec support clinical trials?
Our services include sample management, clinical pharmacokinetics (PK) sample analysis, and radiolabeled human Absorption, Metabolism, and Excretion (hAME) study support.
What additional testing does WuXi AppTec offer in clinical bioanalysis?
We provide clinical metabolite identification and profiling, cross-species metabolite comparison and comprehensive biomarker analysis.
How does WuXi AppTec ensure sample integrity during clinical trials?
We manage all aspects of sample management, including storage, transport, and material management, to ensure sample integrity throughout the study.