Small Molecule Preclinical GLP Bioanalysis
Advance Your Small Molecule IND with Expert Testing
Partner with an expert team that delivers the regulated preclinical bioanalytical support your compound needs for IND submission. WuXi Biology and Testing’s comprehensive programs for small molecules cover the full range of development needs, helping advance your compound more efficiently and effectively.
Preclinical Bioanalytical Studies to Support IND Submission
Our preclinical bioanalytical team brings decades of experience advancing small molecule compounds for IND submission. As an end-to-end partner, we use insights from discovery efforts to eliminate the need to transfer a compound from one unit to another, significantly reducing timelines.
- 340+ preclinical 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 Molecule Preclinical Bioanalysis Capabilities
We offer rapid method development and optimization for small molecules, backed by deep expertise and accelerated synthesis capabilities. Our services cover a wide range of peptides and proteins from various species and sample types, using cutting-edge techniques for accurate and efficient analysis.
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
Explore Solutions for Your Program
Explore solutions by development phase, drug modality, therapeutic area, or integrated discovery needs.
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Preclinical GLP Bioanalysis FAQs
GLP bioanalysis provides rigorous, compliant analysis of biological samples generated during formal safety and toxicology studies, ensuring the data is reliable for regulatory submission.
GLP bioanalysis follows strictly mandated regulatory standards and full method validation to guarantee data integrity, whereas non-GLP bioanalysis offers greater flexibility and speed to support early-stage research decisions.
GLP bioanalysis is required for pivotal preclinical studies that are intended to be submitted to regulatory authorities to support the safety and efficacy of a drug candidate.
Studies required for regulatory filings, such as formal toxicology and safety pharmacology studies, must utilize GLP-compliant bioanalytical support.
Method validation is the systematic process of demonstrating that an analytical method is reliable, reproducible, and accurate, strictly following predefined protocols to meet regulatory requirements for study support.
Liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) is the industry standard for its high sensitivity, selectivity, and robustness in quantifying small molecules in complex biological matrices.
Small molecule analysis typically centers on LC-MS/MS platforms, while large molecule analysis frequently employs ligand-binding assays (LBAs) or hybrid approaches to address the complexities of protein and peptide structures.
It provides the high-quality, regulatory-grade exposure data necessary to establish safety margins and support the justification of clinical starting doses in an IND submission.
A program should transition when it moves from early, iterative lead optimization toward the formal, regulatory-required toxicology studies needed to support an upcoming IND filing.