Bioanalysis

Over 40 years of experience delivering rapid bioanalytical data in discovery, preclinical and clinical development stages.

Rapid bioanalytical data to meet your program's milestones

Delivering rapid bioanalytical data is critical to meeting milestones faster in drug development.

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.

Quotient Sciences are experts in the development, validation, and application of bioanalytical assays. We can help you learn more about your molecule and accelerate your drug program.

Bioanalysis Info Sheet

Bioanalytical services from Quotient Sciences

GLP & GCP accredited laboratories

Our accredited facilities provide comprehensive bioanalytical support to studies at all stages of development.

Short lead times & rapid turnaround for data

We deliver rapid bioanalytical data in the discovery, preclinical, and clinical stages with advanced equipment and systems, including: LC-MS/MS, LC-HR-MS, ICP-MS, ICP-MS/MS, GC-MS, and GC-MS/MS.

Over 40 years of scientific expertise in bioanalytical assays

We are experts in the development, validation, and application of bioanalytical assays with over 40 years of scientific expertise.

Over 400 bioanalytical assays developed, validated, and applied.

We have developed more than 400 methods (LC-MS, GC-MS, ICP-MS) for our customers, with expertise in areas such as insulin analogues & polypeptide drugs, elemental analysis, volatile drugs, and biomarkers.

Integrated toxicokinetics & pharmacokinetics (TK & PK)

We offer expert toxicokinetics (TK) and pharmacokinetics (PK) data analysis and reporting to support pre-clinical and clinical studies. Working together with our expert PK team, we can reduce the risk of downstream delays in later phases of your drug development.

At every stage, we can help you better understand your drug's fate in the human 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.

Using advanced mass spectrometry equipment, we can identify and quantify analytes to determine if, and how, a drug is metabolized in the body. In conjunction with the range of extraction technologies available, we can support you in the development of highly selective and sensitive assays.

Bioanalytical services for small molecule drug development

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.

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)

Global compliance and regulatory

Good Laboratory Practice (GLP)- and Good Clinical Practice (GCP)-accredited laboratories
US Food and Drug Administration (FDA)
European Medicines Agency (EMA)
UK Medicines and Healthcare products Regulatory Agency (MHRA)

Specialist areas of expertise

Insulin analogues and polypeptide drugs
Elemental analysis
Volatile drugs and biomarkers

Comprehensive bioanalytical support at every stage of your drug program

Our dedicated bioanalytical chemists are globally recognized and have decades of experience supporting all stages of drug development. Contact us today discuss your next program.

Preclinical

Drug metabolism and pharmacokinetics (DMPK)
Pre-clinical pharmacology
TK, including GLP toxicology studies
Dose escalation and selection

Phase I

First-in-human (FIH) single ascending dose (SAD) and multiple ascending dose (MAD) studies
Relative bioavailability and PK studies
Clinical pharmacology programs
Drug-drug interaction (DDI) studies
Bioequivalence studies
¹⁴C absorption distribution, metabolism, and excretion (ADME) and mass balance studies
Pharmacodynamic (PD), metabolite and biomarker analysis

Phase II and III

Global, multi-center trials
Relative bioavailability and PK
PD, metabolite, and biomarker analysis

A closer look at our equipment and applications

Instrumentation	Applications
Inductively coupled plasma mass spectrometry (ICP-MS) Inductively coupled plasma tandem mass spectrometry (ICP-MS/MS)	Elemental analysis
Xevo ultra-performance liquid chromatography with tandem mass spectrometry (UPLC-MS/MS)	Analysis of small-molecule new chemical entities (NCEs) Analysis of peptides, small proteins, and new biological entities (NBEs) Highly sensitive, with a lower limit of quantification (LLOQ) <1 ng/mL High throughput
Quantum and Vantage UPLC-MS/MS	Analysis of small-molecule NCEs Sensitive, with a LLOQ ~1 ng/mL High throughput
Gas chromatography with mass spectrometry (GC-MS) Gas chromatography with tandem mass spectrometry (GC-MS/MS)	Detection and analysis of volatile analytes for NCEs and biomarkers
Liquid chromatography with quadrupole time-of-flight mass spectrometry (LC-QTOF-MS)	High-resolution structural identification for NCEs Peptide and protein identification NBE analysis
Liquid chromatography with inductively coupled plasma tandem mass spectrometry (LC-ICP-MS/MS)	Elemental speciation
Liquid chromatography with ion-trap mass spectrometry (LC-TRAP-MS)	High-resolution structural identification for NCEs