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Bioanalysis , Bioanalytical Method Development , Alnwick , Dr. Stuart McDougall

Bioanalysis at Quotient Sciences – Q&A with Stuart McDougall

Stuart McDougall

As the Head of Bioanalytical Services, Stuart leads a diverse team of highly educated bioanalytical chemists who are able to develop, validate, and use very specific and sensitive mass spectrometry-based assays for drugs, metabolites, and biomarkers in a wide variety of biological matrices. Measuring drug exposure in biological systems is fundamental to drug development, in terms of both pharmacokinetics (PK) and pharmacodynamics (PD), to better understand ADME (absorption, distribution, metabolism, and excretion), toxicity, and efficacy.

Can you tell us a bit about yourself?

I have been at the Alnwick facility for over 33 years, and just like our bioanalytical department, my career has evolved over those years. I first started in life sciences as a metabolism scientist in drug metabolism and pharmacokinetics (DMPK), and I now lead a team of talented bioanalytical chemists as department head. Over the years, I have worked for some of the world’s largest organizations, at both pharmaceutical companies and contract research organizations (CROs), and contributed to hundreds of drug development programs. 

Because of my experience, I am currently a member of the European Bioanalysis Forum (EBF), and in this capacity, I work with representatives from member companies to recommend best practices, comment on regulatory issues, and organize scientific meetings to share the latest developments. I am also a member of the American Association of Pharmaceutical Scientists (AAPS), where I have been fortunate to present on bioanalysis in both Europe and the US.

Can you tell us more about your team?

In 2016, the Arcinova bioanalysis department was a small group of scientists, but because of these talented individuals and our customer focus, we paved the way for significant investment in both equipment and people, growing the team to where it is today. My team is brilliant. They are a hardworking group of highly trained and dedicated individuals who work very well together and ultimately get the job done. 

Their dedication to project delivery throughout the course of the last 5 years has not gone unnoticed, and they are greatly appreciated. We could not have gotten to where we are today without them.

While working at the Alnwick site, can you describe the changes within your department?

Innovation is the primary driver in pharmaceutical drug development. As more potent and effective medicines are discovered, the demand for more sophisticated, selective, and sensitive methods for their measurement in biological systems is needed. Over the years that I have worked in the pharmaceutical industry, we have moved away from ultraviolet (UV)-based assays capable of measuring µg/mL levels of drugs, to assays that are now capable of accurately measuring sub-ng/mL levels by mass spectrometry, which is almost a million-fold increase in sensitivity! We are able to utilize this increase in sensitivity to our advantage, measuring the fate of a drug to much lower concentrations, thus enabling us to measure the fate in the body over a longer elimination phase. Additionally, we can also develop analytical methods using much smaller blood volumes, allowing us to support the 3Rs Initiative (Replace, Reduce, Refine), which ethically reduces the number of animals used in drug development, contributing to humane animal research.

What do you think sets your team apart from all the other bioanalytical laboratories across the globe?

We provide quality data on time. It is a simple philosophy. 

We analyze countless numbers of samples for both pre-clinical and clinical trials, we have built and validated over 400 assays, and we leverage innovative technology for liquid chromatography-mass spectrometry (LC-MS). We also specialize in a range of other bioanalytical techniques and have become recognized as specialists in areas such as inductively coupled plasma mass spectrometry (ICP-MS) with a very large number of ICP-MS instruments, and we are probably the largest Good Laboratory Practice (GLP)/Good Clinical Practice (GCP) elemental bioanalytical lab in Europe. 

We have also developed extensive experience in protein and polypeptide analysis by LC-MS. Specifically, we developed and validated LC-MS assays for insulin, as well as the 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.

Our team has over 25 years of experience working on elemental assays, in both PK endpoints (elements in drugs) and PD biomarkers, monitoring changes in element levels in disease states and after treatment.

Our dedicated method development team has accumulated over 100 years of combined experience covering small chemical drugs, polypeptides, proteins, biomarkers, and elements. As such, they are very capable of solving the most complex analytical challenges. 

In addition, our Study Directors and Quality Control teams are very experienced in steering projects and delivering quality data that complies with regulatory guidelines.

Our offering is extensive and covers all areas of bioanalysis. We can support drug development from early pre-clinical up to late-stage Phase III trials, for both small and large molecules by mass spectrometry in biological fluids and tissues. 

Our experience enables us to guide our clients to the best outcome for the project, with quality, care, and on-time delivery.

What is Quotient Sciences’ unique differentiator in bioanalysis?

We pride ourselves on being highly responsive and we have a client-centric approach, which means method development lead times are typically 4 - 6 weeks against an industry standard of 12 weeks or more. Ultimately, if clients choose us as their bioanalytical partner, we can rapidly accelerate their drug development timeline. 

With years of experience both as drug developers and service providers, we have a unique insight into providing our clients with the best possible solutions to their complex drug development problems.

For more information about our bioanalytical services, click here.