For over 30 years, Stuart McDougall, currently Head of Bioanalytical Services at Quotient Sciences, has worked in senior bioanalytical roles some of the worlds largest pharmaceutical companies and CROs. Working alongside a tenured team of multiple industry experts at the Alnwick site, Stuart brings a wealth of knowledge and experience to help clients. The company has a unique insight into what a client needs. “Afterall, our primary focus is our clients. Remaining flexible, agile and responsive is key to a successful project,” states McDougall. He is also heavily involved in bioanalytical regulations and brings forth the expertise of science and regulatory knowledge hand-in-hand.
Essentially, Quotient Sciences covers the entire bioanalytical space and supports all stages of drug development, from early preclinical through to Phase II and Phase III studies, in a fully regulatory compliant way. “The smallest number of samples I have ever analysed on a study is probably less than ten, and the most is 35,000,” adds McDougall. All of the bioanalytical work is mass spectrometry-based, and the firm offers liquid chromatography-mass spectrometry (LC-MS), gas chromatography-mass spectrometry (GC-MS), and inductively coupled plasma mass spectrometry (ICPMS). “Our GC-MS capability is a differentiator for our turnover, and we are unique in the ICP-MS area, and there are not many regulatory compliant elemental labs that I know of,” adds McDougall. ICP-MS capability allows the team measure elements that are very specific to a drug. There are a number of cases where a drug can affect the natural concentration of a component in the body therefore, Arcinova can measure the drug exposure and biomarker exposure too, alongside being able to work with small molecules and volatile elements.
Quotient Sciences: Trusted and Experienced CDMO
We do not see it as a service. It is more of a collaboration
The company’s senior bioanalytical team has over 120 years of combined experience. The dedicated method development team has developed and validated over 400 bespoke assays for a wide variety of small molecules, biomarkers, polypeptides, and small proteins. The firm has a separate quality group that focuses on quality and audits all of the analytical data. “Quality is vital to what a client wants,” states McDougall. One of Arcinova’s key strengths is flexibility. The team are focused on working closely with the client which is an essential part of their work ethic and manifesto. “We do not see it as a service. It is more of a collaboration,” says McDougall.
For instance, the bioanalysis team was working with a client to develop a treatment for Wilson’s disease, a rare genetic disorder in which excess copper builds up in the body. There was no cure available in the market, and patients had to endure treatment for the rest of their lives. Since the preclinical studies, the company joined forces with the client and developed a drug that enabled the control of copper levels. While measuring the drug concentrations and the levels of exposure in patients, they also measured the copper readings in the same patients simultaneously. They observed that when drug concentrations were increased over time after multiple doses, the drug was successful as the copper was being emitted from the body. After nearly ten years, this drug is very close to being on to the market, and currently, it is in the late phase three-stage. “It is a real testament to our collaboration because the drug will soon reach the market, and it will make a significant difference to patient health,” states McDougall.
Forging ahead, the Alnwick site is expanding its offerings on several fronts. The immediate opportunity is to integrate bioanalytical services with clinical pharmacology, pharmacokinetics and data sciences services provided by Quotient Sciences other sites. This integrated offering will provide clients the ability to move seamlessly from clinic to lab to rapid analysis and interpretation – speeding up clinical development times. Secondly there will also be investment in new technologies and instrumentation to remain cutting edged. “We are looking at the technology that we can apply to measure larger proteins or protein-based drugs by mass spectrometry essentially,” says McDougall. The company is also focused on expanding it’s elemental mass spectrometry capability coupled with LC-MS. “It will allow us to look for a particular element or group of elements in a complex mixture, and that has not been done before,” adds McDougall. Since February, 2021, Arcinova is now a part of Quotient Sciences, and their whole ethos now is centred around the concept of ‘molecure to cure, fast’. A concept which is focused on the health and wellbeing of people, because humanity needs cures, fast.