Small Molecule Bioanalysis
Speak to an Expert
about how we can help with your upcoming project
Customizable Services for your Drug Development Journey
WuXi AppTec’s bioanalytical team has the experience and expertise to help you move your drug candidate to the next milestone. We’ll customize a program that meets the evolving needs of your project, from study design to regulatory submission.
Fast facts:
- 200+ validated non-proprietary methods
- 40+ validated new methods for proprietary/innovator molecules every year
- 500,000+ sample analysis capacity
- 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™
Download our Small Molecule Bioanalysis Brochure
Your ability to make intelligent, informed decisions hinges on having the right bioanalytical strategy. We can help you develop an approach that will take you from discovery through preclinical to IND and beyond – with the greatest efficiency and speed.
A Process to Help You Meet Your Milestones
LC-MS/MS Quantitation of Peptides & Proteins
Rapid Method Development
- Peptides 2-4 weeks
- Proteins 4-6 weeks
Extensive Experience
- Resolve non-specific binding
- Sensitivity tune-up
- Trypsin digestion conditions
- Microelution solid phase extraction (SPE) optimization
Diversified Peptides & Proteins
- Different species and matrices
- Hybrid Immunoaffinity LC-MS
Fast Synthesis Capabilities
- 2 weeks turnaround time
- Synthesize surrogate peptide
- Synthesize SIL-IS
Experience in Diverse Small Molecule Compound Classes
- Common new chemical entities (NCE)
- Polar/non-polar and low molecular weight analytes
- Endogenous analytes
Proven Expertise Across Species & Matrices
Comprehensive Quality Management System
State-of-the-Art Instrumentation
- 70+ UPLC™-MS/MS instruments globally
- SCIEX API Triple Quad™ 4000/5000/5500/6500/6500+
- Waters Xevo® TQ-S
- Waters UPLC™/Shimadzu HPLC/Agilent HPLC/Shimadzu UHPLC
- Fully automatic LC method scouting system
- PerkinElmer Janus® liquid handling system
- TomTec® liquid handling system
Integrated Bioanalytical Service for Global Submissions
- GLP/non-GLP bioanalytical facilities
- Central laboratory services – safety lab and clinical kits
- Support for innovator and generic drugs
- Clinical and preclinical study support
- Regulatory support of bioanalytical studies for global submissions
- Drug Enforcement Agency-inspected, state licensed for radioactivity use (U.S.)
Small Molecule FAQs
What is small molecule bioanalysis?
The analysis of small molecules involves accurately measuring the levels of low molecular weight compounds, including drugs and their byproducts, in different biological samples. This is essential for assessing small molecule treatments’ effectiveness, safety and pharmacokinetics.
Why is bioanalytical testing important for small molecules?
Studying the bioanalytical aspects of small molecules is crucial for gaining insights into their absorption, distribution, metabolism and excretion (ADME) properties. This knowledge is instrumental in determining the appropriate dosage, evaluating therapeutic effectiveness and safeguarding patient well-being.
What types of samples are analyzed in small molecule bioanalysis?
Various types of samples, such as blood, plasma, serum, urine, tissue, and other biological fluids, are examined to measure the levels of small molecule drugs and their metabolites.
What types of samples are analyzed in small molecule bioanalysis?
Various types of samples, such as blood, plasma, serum, urine, tissue, and other biological fluids, are examined to measure the levels of small molecule drugs and their metabolites.
What analytical techniques are used in small molecule bioanalysis?
In small molecule bioanalysis, commonly utilized techniques include liquid chromatography-mass spectrometry (LC-MS), gas chromatography-mass spectrometry (GC-MS) and high-performance liquid chromatography (HPLC). These methods offer high sensitivity and specificity in detecting and quantifying analytes.
How are bioanalytical methods validated for small molecules?
Small molecule bioanalytical methods are validated in accordance with regulatory guidelines to guarantee accuracy, precision, sensitivity, specificity, reproducibility and robustness. Validation is essential to ensure that the methods consistently yield reliable and consistent results.
Can customized bioanalytical services be provided for small molecule projects?
Yes, tailored bioanalytical services can be customized to suit the specific requirements of various small molecule projects. This involves creating and validating distinct analytical methods to tackle particular research inquiries.
What are the challenges in small molecule bioanalysis?
Overcoming challenges in small molecule bioanalysis necessitates addressing low analyte concentrations, matrix effects in complex biological samples and the need for high sensitivity and specificity. Experienced scientists and advanced techniques play a crucial role in conquering these obstacles.
How long does it typically take to complete a small molecule bioanalysis study?
The length of a small molecule bioanalysis study varies depending on the project’s complexity, sample quantity and necessary analytical techniques. Typically, timelines are established and agreed upon during the project planning phase.
What services does WuXi AppTec offer for small molecule bioanalysis?
WuXi AppTec provides comprehensive small molecule bioanalytical services tailored for drug development, from study design to regulatory submission. Our services include a selection of standard assays and a team that can develop custom biomarkers from method development through validation, including high-throughput sample analysis.
What technologies are used in WuXi AppTec's small molecule bioanalysis?
The laboratory utilizes state-of-the-art mass spectrometry platforms, including UHPLC-MS/MS and automated and semi-automated 21 CFR Part 11-compliant systems.
Can WuXi AppTec handle high volumes of sample analysis for small molecules?
Yes, the facilities can analyze more than 500,000 samples and routinely develop more than 40 new methods for proprietary molecules annually.
Does WuXi AppTec support regulatory submissions for small molecule studies?
Yes, we offer integrated bioanalytical services that support innovator and generic drugs for global regulatory submissions, including studies for clinical and preclinical phases.
What types of compounds and matrices can WuXi AppTec analyze?
WuXi AppTec has extensive experience with diverse small molecule compound classes and biological matrices, supporting studies across various species.
Where are WuXi AppTec’s bioanalytical labs located?
We have leading integrated laboratory operations in New Jersey and China, including Central Laboratory Services.