Biological drugs

Quotient Bioresearch’s unique heritage in sports drug surveillance and biomarker discovery has created an innovative bioanalytical group with a broad range of capabilities and expertise for the analysis of biological drugs.

Quotient Bioresearch is a cutting-edge laboratory with the latest equipment and techniques to hand, including BioMS™, Gyrolab™ and MSD™. We have many years’ experience providing support to every stage of the drug development process, providing fully project managed support from kick-off to reporting.

• Preclinical and clinical support - supporting regulated and non-regulated preclinical studies as well as Phase I to IV clinical studies - including first in man, proof of concept, drug-drug interaction and bioequivalence
• Method development and validation - feasibility assessment, method establishment, method development and validation to GxP. We are experienced with a variety of species and matrices and use a wide selection of analytical techniques including pharmacokinetics and PK/PD modelling. We are able to carry out off-the-shelf biomarker screening in addition to developing completely new biomarker methods for your projects and have extensive experience in the discovery and development of bespoke biomarker methods.
• Sample analysis – we offer a rapid sample turnaround, with automated sample handling. We will work to sponsor specific study plans or our own plans, and provide quick and accurate results, analysis and reporting
• Quality and management - we offer single point of contact management from a dedicated client manager or study director. We provide regular project updates at schedules to meet your sponsor timelines and offer secure web reporting for multi-centre trials.

Contact us for more information and to discuss your specific needs.

Further reading

The following downloads are available as .pdf files, or get in touch for a hard copy.

• Bioanalysis & immunogenicity of biological therapeutics – fact sheet with more information about our biological drug development services
• Proteomics - information about the technologies and techniques used for protein analysis