Bioanalysis
metabolite profiling studies .
Precision Bioanalytical Solutions for Small Molecule Drugs
Tailored method validation, advanced metabolite profiling, and flexible non‑GLP analysis to accelerate drug development.
Our Approach to Quality Bioanalytical Services
Our Analytical Services department provides high-quality support for both our internal contract service groups and external clients, meeting all your bioanalytical and analytical needs.
Custom Method Development & Analysis
Our team excels in developing custom methods for:
In Vitro Studies:
Supporting all study types with tailored sample analysis.
In Vivo Models:
Extending our expertise to many animal models.
We utilize advanced instrumentation to ensure sensitive and selective quantitation:
LC-MS/MS Analysis:
Performed using triple quadrupole and QTrap mass spectrometers, integrated with UPLC systems and rack changers.
Hybridization Analysis:
Offering techniques such as ELOSA and PALSAR, with qPCR as an alternative when LC-MS/MS is insufficient.
Regulated Projects
For regulated projects, we adhere to the FDA Bioanalytical Guidance, ensuring that all methods are properly validated for compliance and reliability.
Chromatographic Separation & Metabolite Profiling
We offer a variety of chromatographic techniques tailored to diverse small molecule matrices:
Techniques:
Reverse-phase, ion-pair, and HILIC.
Matrices:
Plasma, urine, bile, feces, and tissue homogenate.
Our expertise also extends to metabolite profiling and identification:
Test Articles:
Working with both cold and radiolabeled compounds.
Detectors:
Utilizing UV-Vis/PDA/β-Ram detectors alongside high-resolution QToF mass spectrometers.
Additionally, our team routinely supports:
Structure Elucidation
Biotransformation Assignments
Method Development
Bioanalytical Services for Small Peptide Drug Candidates
Bioanalysis Services
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In Vivo Metabolite Identification
Our In Vivo Metabolite Identification service involves characterization and identification of metabolites using LC-MS/MS for treated biological matrices including bioanalytical services for whole blood, plasma, feces, urine, or bile from clinical or nonclinical in vivo studies.
Small Molecule Analysis
Our team can perform Small Molecule Bioanalysis services through high-precision quantitative measurement of a drug compound and/or its metabolites in various biological matrices (urine, blood, plasma, serum, etc.).
Intermediate / “Milli-Molecule” (ADC, Oligonucleotide) Analysis
Our team conducts bioanalysis on molecules with 14-30mer (molecular weight > 4.5 kDa but<10kDa), such as oligonucleotides, through high-precision quantitative measurement of a drug compound in various biological matrices (urine, blood, plasma, serum, etc.).
Toxicokinetic (TK) Analysis
Toxicokinetic (TK) analysis following definitive toxicology studies provide the detailed systemic exposure profile essential for dosing considerations prior to first-in-human (FIH) studies and other clinical phases. The Drug Development Solutions Center can offer GLP-certified bioanalytical follow-up to establish a correlation between a candidate compound’s concentration or dose and its potential toxicity.
Method Validation & Qualification
Our team’s extensive experience, scholastic knowledge of regulatory guidelines and expectations, and strict internal Quality Assurance/Control standards allow validation of developed methods to ensure compliance with current FDA and EMA Bioanalytical guidelines.
Our Quality Assurance Unit (QAU) is committed to ensuring industry and regulatory standards are met or exceeded within our organization. We frequently welcome representatives from client companies to visit our lab to tour our facilities and see for themselves the high standards of quality we are proud to maintain. The QAU performs audits and inspections confirming services and product compliance to protocols, SOPs and regulatory standards, as applicable. Quality Control is performed independent of the QAU by qualified staff.
The QAU provides timely and accurate compliance feedback; specializing in FDA, OECD and MHLW GLP compliance.
The team provides the following services:
GLP study audits
Non-GLP study audits (per sponsor request)
Production audits
Computer System Validation audits
Method Validation audits
Facility audits
Process-based audits
Vendor and Supplier audits
Maintain the CAPA and deviations report system
Identification of process improvements through detailed SOP reviews
Identification of best practices through reviews of industry and regulatory guidance and trends
Company-wide compliance training
Quality System
Our Quality System is based on the principles of GLP. All studies are conducted following the same requirements for planning, documentation and archiving. Each study’s performance, reporting, monitoring and archiving duration are specific to the sponsor’s requirements. All XenoTech products adhere to the same GLP principles with exceptions defined in production SOPs.
Instrumentation Capabilities for Bioanalytical Services
Multiple Sciex 4000 QTrap, 4500 triple quadrupole and 5500 QTrap MS/MS systems
Multiple Waters™ Xevo TQ-S triple quadrupole with Acquity UPLC system
Waters™ Xevo G2-XS QTof with Acquity UPLC system
Waters™ Xevo G3 QTof (Quadrupole Time of flight) with Acquity Premier system
Shimadzu Nexera UHPLC systems with rack changers and column switching oven
LabLogic β-RAM radiometric detectors
Luminex® 100/200TM System
MSD® QuickPlex SQ120TM System
Marker metabolite methods validated according to FDA Bioanalytical Method Validation Guidelines
PDA detector in-line for qualitative assessment
Automated liquid handlers (Tecan) for sample preparation