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Aug 4, 2017 | Biopharma, Blogs, Pharma | 0 comments
An Interview with Timothy Sangster, Head of Bioanalysis and Immunology, Charles River Laboratories, Edinburgh
Charles River Laboratories is a fast-growing CRO with 70 facilities in 16 countries, and recent acquisitions include the bioanalytical company Agilux. The company’s site in Edinburgh offers large bioanalytical capability, primarily for pharmaceutical applications, but also with some projects in the agrochemical, veterinary and chemical fields along the way. With 34 mass spectrometers on site, including 28 SCIEX Triple Quads, it is one of the larger CRO installations for SCIEX in Europe.
Tim Sangster, Head of Bioanalysis and Immunology in Edinburgh, described his multifunctional department, “Our team of 70 scientists is split into four sections: Immunology, supporting clinical and pre-clinical immunological studies using either cell-based assays or flow cytometry endpoints for functional and biomarker assays. Immunochemistry, ELISA and hybridization assays, and regulated and non-regulated chromatography.”
“There is a fair amount of interaction between the teams, for example, if the chromatography teams are dealing with unusual proteins and peptides, having our immunology and immunochemistry colleagues close at hand is a real advantage. They can advise about biological influences like binding and blocking agents, and this was a great help in the early days of using immunoaffinity techniques to clean up a peptide, and get the necessary sensitivity.”
“The reason for the distinction between the chromatography departments is the different workflows. The regulated work involves taking an assay, validating it, running samples and getting data out to the client, making sure that it meets regulatory requirements. The facility is heavily regulated for GLP and GCP, and has been for many years; these are relatively long-term studies, with a large degree of structure and organization.”
“There are two aspects to the non-regulated work, development, and discovery. Development feeds into the regulated team, developing the assays, troubleshooting any problems, and then handing them over for validation and running the sample analysis. The discovery team is frequently working on a two-week turnaround; high throughput, quick analysis, getting the right answers that meet the clients’ requirements.”
Tim explained, “The crucial difference between the non-regulated and regulated teams is that the former is not hampered by any regulations that might affect the scientific decision-making. In contrast, the regulated team, while also thinking scientifically, is driven by regulation. This difference in approach works well for us. Regulation and accreditation is, of course, a key driver for our industry, but people tend to forget that CROs have client audits on a very regular, often monthly, basis. Constant auditing like this means that we must have incredibly robust processes in place and this is where SCIEX instrumentation comes to the fore.”
He continued, “It is important within a regulated environment not to have several different platforms. We have a number of API 3000 Systems that are heavily used for in vitro assays where the selectivity of a triple quad system is more important than sensitivity, and our workhorse instrument is the API 4000TM, which still, in my mind, is one of the best instruments SCIEX has ever made. It’s a joy, and I love it; robust, rock-solid, we have 10 on site.
Our latest addition is a QTRAP® 6500 System, which is proving invaluable in the non- regulated space, where the enhanced linearity and sensitivity make discovery a much simpler workflow. We were also starting to see more programs that needed enhanced sensitivity, particularly for pre-clinical inhalation and dermal compounds, where we are frequently required to prove a negative. The question that always comes back from the regulator under these circumstances is ‘how well did you look?’ By using, for example, enhanced chromatography systems, UHPLC, coupled to the front end of a 6500, we can pretty much say we’ve tried everything that’s possible. For macromolecules too, where you’re getting dilution of your signal by the formation of multiple charge states, sensitivity again becomes an issue that the system has helped us to resolve. Another very important driver for getting the QTRAP 6500 was capillary microsampling, which is the way forward for us in the pre-clinical arena particularly. Having enhanced sensitivity gives us the flexibility to be able to do this; it’s a real focus for Charles River and one of my passions.”
Tim added, “Analyst® software is validated for all of our platforms, and it is, of course, much better for consistency across the departments to stay with a single supplier. However, the main reason we have stayed with SCIEX is that we haven’t seen a justifiable benefit to change. We always look around at what alternative technologies are available whenever we’re looking for new solutions, but we haven’t yet seen a significant business advantage to any of the other systems that are out there.”
“All of our instruments are working to capacity most of the time. Service is a very important consideration, and we have a full-service contract with SCIEX, simply because there is much better support direct from a vendor if ever there are major problems. It’s rare with SCIEX, but we cannot afford to lose any of our instruments for any length of time, so having that trust and support is crucial.”Find out more about the SCIEX QTRAP 6500 System >
This article is from the 2017 edition of the SCIEX VISION journal. You can download the full version of the journal which includes over 10 customer research stories. Download now >
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