Bioanalytical Services
Delivering rapid bioanalytical data in discovery – pre-clinical – clinical. Bioanalysis is a critical step in the drug development process. At Quotient Sciences, we are experts in the development, validation, and application of bioanalytical assays. Our dedicated team of bioanalytical chemists are globally recognized and possess over 40 years of experience in supporting all stages of drug development, from early pre-clinical through to first-in-human (FIH), Phase I, and onwards to Phase II–III studies.
Bioanalytical expertise
- Bioanalytical assay development, validation, and application
- Liquid chromatography with tandem mass spectrometry (LC-MS/MS)
- Inductively coupled plasma tandem mass spectrometry (ICP-MS/MS)
- Gas chromatography with tandem mass spectrometry (GC-MS/MS)
- High-resolution mass spectrometry
- Liquid chromatography with ion-trap mass spectrometry (LC-TRAP-MS)
- Liquid chromatography with time-of-flight mass spectrometry (LC-TOF-MS)
- Rapid turnaround time of pre-clinical and clinical samples
- Even quicker with ‘Priority Analysis’ (72-hour turnaround time)
- Good Laboratory Practice (GLP)- and Good Clinical Practice (GCP)-accredited laboratories
- Global compliance
- US Food and Drug Administration (FDA)
- European Medicines Agency (EMA)
- UK Medicines and Healthcare products Regulatory Agency (MHRA)
- Expertise in specialist areas
- Insulin analogues and polypeptide drugs by LC-MS/MS
- Elemental analysis by inductively coupled plasma mass spectrometry (ICP-MS)
- Volatile drugs and biomarkers by gas chromatography with mass spectrometry (GC-MS)
- Metabolite identification
We can help you develop a clearer understanding of what is happening to your drug molecule as it progresses through the body. Our high-resolution instruments can improve the validity and quantity of the data you require. With our cutting-edge mass spectrometry platforms, we can identify and quantify analytes to assess if your drug is metabolized in the body.
State-of-the-art equipment
- LC-MS/MS
- Liquid chromatography with high-resolution mass spectrometry (LC-HRMS)
- ICP-MS
- ICP-MS/MS
- GC-MS
- GC-MS/MS
Non-clinical and clinical bioanalysis
Quotient Sciences provides comprehensive bioanalytical services within a state-of-the-art facility. The experienced team of globally recognized experts can quickly develop, validate, and implement bioanalytical LC-MS, GC-MS, and ICP-MS assays for small- and large-molecule drugs, biomarkers, and elements in compliance with regulatory expectations. Our team have extensive project experience to support all stages of drug development, from early pre-clinical, FIH, and through to Phase II and III studies.
We produce bioanalytical LC-MS, GC-MS, and ICP-MS assays in compliance with regulatory standards. Three of our eight triple quadrupole (TQ) instruments are new, ultra-high sensitivity Waters Xevo® TQ-XS systems equipped with ultra-performance liquid chromatography (UPLC). In addition to this, we have a Sciex TripleTOF® 6600 that allows collection of high-resolution mass spectrometry data, and can be used to quantify an impressive range of molecules, from small molecules to proteins. When used in conjunction with the wide range of extraction technologies available to us, we can develop highly selective and sensitive assays.
Study types we support
- Pre-clinical toxicology and drug metabolism and pharmacokinetics (DMPK) studies
- Phase I
- FIH
- Relative bioavailability/pharmacokinetics (PK)
- Drug-drug interaction (DDI)
- Bioequivalence
- 14C absorption, distribution, metabolism, and excretion (ADME)/mass balance
- Pharmacodynamics/biomarkers
- Phase II and III
- Multi-center global trials
We offer bioanalytical services on both a stand-alone basis and as part of a fully integrated program, with expert PK and toxicokinetic (TK) data analysis and reporting, to accelerate your drug development.
Toxicokinetics and pharmacokinetics
- Non-clinical and clinical support
- PK parameter calculations
- Cmax, Tmax, AUC, etc.
- Phoenix WinNonlin software
- TK reports
- Interim and final PK reports
- Clinical Data Interchange Standards Consortium (CDISC) format/full data sciences
Sample management
- Fully integrated chain of custody Watson LIMS software
- 1-dimensional (1D) and 2-dimentional (2D) barcode accession
- Datasets in standard for exchange of non-clinical data (SEND) and study data tabulation model (SDTM) format
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Info SheetBioanalytical ServicesDetermining drug exposure is vital for the assessment of drug safety and efficacy. Quotient's Bioanalytical team, develop and refine methods so exposure can be assessed reliably and accurately in a variety of biological matrices.
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Case StudiesBiochemical Assay Optimization, Validation & Application Case StudyUK specialty-pharma company in need of biochemical assay for their regulatory non-clinical safety study
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Case StudiesAnalysis of Insulin Analogues Case StudyEuropean biotech company developing an NCE to fulfil an unmet patient need, required insulin analogue analysis to gain regulatory approval
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Scientific PostersWhy Archiving is a Crucial Part of Any Clinical TrialA Quotient Sciences Poster by Erika Reategui, Director, GCP Quality Assurance, Quality Assurance: Why Archiving is a Crucial Part of Any Clinical Trial
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