Quotient Bioresearch Blog

The use of biologically derived proteins used as therapeutic agents is increasing in the pharmaceutical industry. Biological therapeutics can be defined as a therapeutic agent derived form a living organism e.g. Antibody. They are usually large molecules, ranging from ~20,000 Daltons (Interferon-Alpha) to 150,000 Daltons (Antibodies).

Quotient Bioresearch Enters Partnership Agreement with ANAWA

Quotient has entered a partnership agreement with ANAWA Trading SA to provide an Iodine-125 labelling service to customers.

Molecular Biomarkers used to Assess a Novel Treatment of COPD; The Importance of Sample Processing and the MIQE Guidelines. The Global Initiative for Obstructive Lung Disease (GOLD) defines Chronic Obstructive Pulmonary Disease (COPD) as a “disease state characterized by airflow limitation that is not fully reversible. The airflow limitation is usually both progressive and associated with an abnormal inflammatory response of the lungs to noxious particles or gases”*.

GLP-compliant Drug Transporter Efflux Testing Platform

Two recent events have further highlighted the growing field of drug transporter testing with  regards to drug-drug interaction (DDI) assessment.  In February, the FDA released their revised draft guidance on DDI testing which included expanded and more comprehensive recommendations for drug transporter testing. 

The 7th Annual Biomarkers Congress 2012, co-located with the inaugural 1st CNS Biomarkers Congress presented by Oxford Global Conferences, took place in Manchester, UK. Over the 2 days, the comprehensive and scientific programme featured key note addresses, case study presentations, panel and roundtable discussions of over 50 senior level industry speakers from leading pharmaceutical, biotechnology, diagnostics, clinical research companies and academic institutions.

Quotient upgrade to the latest LabLogic software

To improve efficiency, data robustness, and speed of delivery to our customers, we have upgraded to the latest Lablogic software platforms (Debra version 5.7.10 and Laura version 4.1.3) for our radiolabelled metabolism studies and radiochromatography work.

ASCPT Annual Meeting 2012

The American Society for Clinical Pharmacology and Therapeutics (ASCPT) meeting was held in Maryland USA last week. As the premier organisation in the field of clinical pharmacology, ASCPT put together an outstanding scientific programme,  internationally renowned speakers,
and abundant networking opportunities.

Metabolism & Residue Kinetics of Veterinary Drugs in Food-producing Animals

Veterinary medicines have an important role in the control of disease and prevention of animal suffering but also have the potential to cause harm if incorrectly used. Statutory controls have therefore been established to protect consumers from the effects of harmful residues of these medicines in their food.

Biomarkers in drug development - The quantification of small molecule exploratory biomarkers can present a significant added challenge over and above that faced for regulated bioanalysis of xenobiotic drugs.  With an increase in the use of biomarkers in drug development, limited sample volume and endogenous assay validation, the development of robust high-throughput multianalyte assays has become a regular challenge.  Whilst “fit-for-purpose” assay validations are proposed for large molecule biomarker analysis, when and where is this applicable to small molecule LC-MS/MS assays?

Use of a CAPA system in handling anomalous results – with a focus on maintaining GCP compliance. A CAPA (corrective and preventative action) system is a useful tool in managing anomalous results. The advantage of a CAPA system is that Quality Assurance become responsible for monitoring the progress of the investigation and ensuring it is documented correctly and closed out in a timely manner. Also, if an electronic CAPA system is used it is possible to monitor trends in the nature and frequency of anomalies and report these to management.