How Can We Help?
Skip to content
Lab technician with dropper into lab test tubes

Bioanalytical Services for Nonclinical Testing in Drug Development

Our Analytical Services group offers custom method validation, method qualification, in vivo metabolite profiling studies and non-GLP bioanalytical services for small molecule drugs. For regulated projects, methods are validated in accordance with the Food and Drug Administration (FDA) Bioanalytical Guidance.

Our Approach to Quality Bioanalytical Services

Our Analytical Services department specializes in high-quality support for all the bioanalytical services and analytical needs of our internal contract service groups and for external clients. 

The team is highly experienced with custom method development to support sample analysis for all in vitro study types. We perform LC-MS/MS analysis using triple quadrupole and QTrap mass spectrometers equipped with UPLC systems and rack changers for sensitive and selective quantitation of drug candidates or marker substrates with increased efficiency.

Our chromatographic separation capabilities include techniques such as reverse-phase, ion-pair, HILIC for a wide range of small molecules in various matrices such as plasma, urine, bile, feces and tissue homogenate. We have extensive metabolite profiling and identification expertise with cold and radiolabeled test articles with UV-Vis/PDA/β-Ram detector orthogonal with high-resolution QToF mass spectrometers. The team routinely performs structure elucidation, biotransformation assignments, method development, and bioanalytical services for small peptide drug candidates.

Bioanalysis Services We Offer

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 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.

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.).

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.

Instrumentation Capabilities for Bioanalytical Services

  • Multiple Xevo TQ-S triple quadrupole, AB Sciex API 2000 and API 3000 triple quadrupole, a 4500 triple quadrupole, and API 4000 and 5500 QTrap MS/MS systems
  • Xevo G2-XS QTof/Tof
  • Waters Synapt™ G2 HDMS Q-TOF
  • Waters Acquity UPLC™ systems
  • Shimadzu Nexera UHPLC, UFLC and Prominence LC systems
  • IN/US β-RAM radiometric detectors
  • Assays validated according to FDA Bioanalytical Guidelines
  • LC-UV in-line for qualitative assessment
  • Automated liquid handlers (Tecan) for consistent sample processing
Human CYP markersUGT, MAO and othersAnimal P450sDrug Transport
1′ -Hydroxy midazolam (3A4)Estradiol-3-β-D- glucuronide (UGT1A1)Rat Hydroxy- testosterone (2α, 6β, 7α, 16β)Digoxin (MDR1)
6β-Hydroxy testosterone (3A4)Chenodeoxycholic acid glucuronide (UGT1A3)Dog Hydroxy testosterone
(6β, 16α)
Prazosin (BCRP)
Oxidized nifedipine (3A4)Trifluoperazine glucuronide (UGT1A4)Mouse Hydroxy- testosterone (6β, 15α, 16β) 
ortho-Hydroxy atorvastatin (3A4)Naphthol glucuronide (UGT1A6)Monkey Hydroxy-testosterone (2β, 6β, 16α, 16β) 
Acetaminophen (1A2)Propofol glucuronide (UGT1A9)  
Dextrorphan (2D6)Morphine-3-β-D-glucuronide (UGT2B7)  
Hydroxy bufuralol (2D6)Testosterone-β-D glucuronide (UGT2B17)  
7-Hydroxy coumarin (2A6)4-Methylumbelliferyl glucuronide (UGTs)  
Hydroxy bupropion (2B6)5-Hydroxy tryptophol (MAO-A)  
8-Hydroxy efavirenz (2B6)Dimethylamino benzaldehyde (MAO-B)  
6α-Hydroxy paclitaxel (2C8)Vanillic acid (Aldehyde Oxidase)  
N-Desethyl amodiaquine (2C8)Phthalazone (Aldehyde Oxidase)  
4′ -Hydroxy diclofenac (2C9)5-Aceominosalicylic acid (NAT-1)  
4-Hydroxy tolbutamide (2C9)   
4′ -Hydroxy mephenytoin (2C19)   
6-Hydroxy chlorzoxazone (2E1)   
Hydroxy ebastine (2J2)   
12-Hydroxy lauric acid (4A11)   
17α-Hydroxy testosterone (CYP17)  

Emphasis on Quality

Read more about bioanalytical method validation, reporting, and regulatory compliance in our bioanalytical studies

Global Headquarters in Kansas City (USA)