In the discovery phase, bioanalytical testing is essential for gaining insights into the pharmacokinetic (PK) profiles, bioavailability, and metabolic pathways of new drug candidates. This information plays a crucial role in selecting promising compounds for further development.

Commonly utilized techniques in discovery bioanalysis involve liquid chromatography-mass spectrometry (LC-MS), gas chromatography-mass spectrometry (GC-MS) and other sophisticated chromatographic and spectrometric methods. These techniques offer high sensitivity and specificity in detecting compounds.

Bioanalytical methods are created in the discovery phase through a systematic approach that involves selecting suitable techniques, optimizing conditions, and validating the methods to guarantee accuracy, precision, and robustness.

Discovery bioanalysis challenges arise from managing low concentrations of drug candidates, matrix effects from complex biological samples and the requirement for quick turnaround times. These challenges can be overcome with advanced analytical techniques and experienced scientists.

Yes, bioanalytical methods can be customized to meet the specific needs of various discovery projects. This can involve creating unique assays and refining existing methods for particular research requirements.

The data obtained from discovery bioanalysis is utilized to make informed decisions regarding the suitability of drug candidates. This involves evaluating their pharmacokinetic properties, metabolic stability, and potential efficacy, guiding further development.

Although the discovery phase is typically less regulated than later stages, it is crucial to adhere to best practices and scientific standards. Following guidelines from international regulatory bodies ensures the reliability of the generated data and its ability to support future regulatory submissions.

The duration of discovery bioanalysis studies varies depending on the project’s complexity and the number of samples requiring analysis. Timelines are usually shorter in the discovery phase than in later stages, enabling swift decision-making.

WuXi AppTec provides non-GLP bioanalytical services for drug discovery, including in vitro ADME, discovery biology, pharmacokinetics (PK), pharmacodynamics (PD), and discovery toxicology.

Our labs are equipped with high-throughput technologies, such as HPLC, UHPLC, mass spectrometry, and various immunoassay platforms, to support small- and large-molecule development.

Yes, our bioreagent team develops customized antibodies, proteins, and peptides to support assessments of immunogenicity, PK, and PD for therapeutic candidates.

We offer capabilities like immunogenicity testing, receptor occupancy, biomarker analysis, and cell-based assays for biologics development.