Bioanalysis
Highly sensitive bioanalytical techniques enable the identification and quantification of analytes, such as small molecules, peptides, proteins, nucleic acids, and metabolites, all from very small volumes of biological samples. Delivering rapid bioanalytical data is critical to meeting milestones in drug development. From drug discovery to pre-clinical and clinical studies, understanding drug exposure, safety, and metabolism are essential in accelerating drugs to clinic and commercialization.
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 have over 40 years of experience in supporting all stages of drug development, from early pre-clinical, through to first-in-human (FIH), and onwards to Phase II and III patient studies. At every stage, we help our customers gain a clear understanding of the fate of their drug in the body. Combining our development and validation experience of over 400 bioanalytical assays, along with our integrated service lines, we can ensure that critical decision-making data are rapidly processed, robust, and reliable.
Find out more about Quotient Sciences’ bioanalytical services in our info sheet.
Bioanalytical expertise
- >40 years of scientific expertise
- >400 bioanalytical assays developed, validated, and applied for a wide spectrum of matrices
- Broad range of platforms
- Liquid chromatography with mass spectrometry (LC-MS)
- Inductively coupled plasma mass spectrometry (ICP-MS)
- Gas chromatography with mass spectrometry (GC-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 times for pre-clinical and clinical samples
- 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)
- Integrated toxicokinetic (TK) and pharmacokinetic (PK) analysis and reporting
- Secure sample and data management
- Expertise in specialist areas
- Insulin analogues and polypeptide drugs
- Elemental analysis
- Volatile drugs and biomarkers
Study types we support
In our GLP- and GCP-accredited facilities, we provide comprehensive bioanalytical support to studies throughout drug development, from pre-clinical, through to Phase I, and onwards to Phase II and III.
Pre-clinical
- Drug metabolism and pharmacokinetics (DMPK)
- Pre-clinical pharmacology
- TK, including GLP toxicology studies
- Dose escalation and selection
Phase I
- FIH – single ascending dose (SAD) and multiple ascending dose (MAD)
- Relative bioavailability and PK
- Clinical pharmacology
- Drug-drug interaction (DDI)
- Bioequivalence
- 14C absorption, distribution, metabolism, and excretion (ADME) and mass balance
- Pharmacodynamic (PD), metabolite, and biomarker analysis
Phase II and III
- Global, multi-center trials
- Relative bioavailability and PK
- PD, metabolite, and biomarker analysis
State-of-the-art equipment
At our state-of-the-art facility, our 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 standards. With our cutting-edge mass spectrometry platforms, we can identify and quantify analytes to determine if, and how, a drug is metabolized in the body. When used in conjunction with the wide range of extraction technologies available to us, we can develop highly selective and sensitive assays.
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New Drug Substance Facility is now open at Alnwick
Watch highlights from the opening event of our new drug substance facility at Alnwick.
Integrated toxicokinetics and pharmacokinetics
TK and PK analysis helps to provide a dose-related assessment of the absorption and distribution of a molecule, how it is metabolized in the body, and how it is excreted.
At Quotient Sciences, our industry-leading experts offer TK and PK data analysis and reporting, supporting both pre-clinical and clinical studies, including:
- 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
By integrating bioanalysis with TK and PK analysis, we accelerate the delivery of data and improve decision-making, reducing the risk of downstream delays.
Secure sample and data management
The use of highly sophisticated bioanalytical techniques generates large amounts of data, which are critical for development and regulatory approval. It is, therefore, vital to ensure that secure systems are in place to store, organize, and manage bioanalytical samples and corresponding data, while continuously safeguarding quality and integrity.
At Quotient Sciences, our fully integrated chain of custody uses 1-dimensional (1D) and 2-dimentional (2D) barcode accession to enable sample security and traceability. We have full data science capabilities in-house and provide data in CDISC formats, SEND (Standard for Exchange of Non-clinical Data) for non-clinical datasets and SDTM (Study Data Tabulation Model) for clinical bioanalytical data, to meet the needs of our customers and align with regulatory requirements.
Case study
Analysis of insulin analogues
At Quotient Sciences, we have developed and validated LC-MS assays for commercial insulin analogues used for treating Type I diabetes. These assays are very selective and able to measure extremely low levels of insulin drugs and their active metabolites in plasma.
In one client case study, a European biotech company that was developing an NCE to fulfil an unmet patient need required insulin analogue analysis to gain regulatory approval. Pivotal clinical studies require precise measurement of multiple insulin analogues from a small volume of plasma. The existing methodologies enabled successful proof of concept and non-regulated PK studies to be completed but did not meet the precision necessary for regulatory acceptance. At Quotient Sciences, a new mass spectrometer was purchased, installed, and verified for insulin analogue analysis within 4 months, meeting the customer’s timeline for a key clinical trial. All clinical samples were analyzed and provided key endpoint data for the study.