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19 July 2021 | Story Lunga Luthuli | Photo Supplied
Fletcher Hiten, Chief Bioanalyst at FARMOVS, next to Aurora.

The Bioanalytical Services Division (BASD) at FARMOVS comprises a group of skilled and passionate scientists involved in the quantification of drugs, metabolites, and biomarkers in various biological matrices. One of their Analytical Science experts, Fletcher Hiten, explains what sets their team apart from the rest.

“Over the past 47 years, we have developed almost 600 validated assay methods. Most of these methods are for the analysis of ‘small’ molecules using chromatographic techniques such as LC-MS/MS, GC-MS, and HPLC, although LC-MS/MS is the technique of choice. New bioanalytical assays are continuously being development and validated in adherence to international regulatory guidelines set by the US-FDA and European Medicines Agency (EMA),” says Hiten.

“Recently, we decided to enhance our capabilities by recruiting exceptional talent. The newest member of the FARMOVS team is Aurora, a SCIEX Triple Quad™ 7500 LC-MS/MS mass analyser. Aurora is Latin for ‘dawn’: the beginning of a new era, especially one considered favourable. The SCIEX 7500 is currently marketed as the most sensitive triple quadrupole mass spectrometer available, allowing for sub-picogram/ml quantification. This means that Aurora will set FARMOVS apart from other clinical research organisations (CROs), creating an exciting and favourable landscape for clients to explore new partners in research.” 

Hiten stated: “If there was ever a time to move your next study to FARMOVS, it is now. To have Aurora on our team has many advantages, given that our clients can access unprecedented analytical sensitivity, which enables the quantification of pharmacokinetic (PK) profiles of drugs that have very low systemic absorption. These include predominantly local acting drugs, such as plasma concentrations of respiratory drugs (e.g., tiotropium and ipratropium), topically applied creams and ointments, and ophthalmology drops with ultra-sensitivity.”

“In addition, the quantification of drugs in low-volume matrices will also be exponentially enhanced, enabling the quantification of body fluids, where only a few microlitres can be collected, for example vaginal fluid, dried blood spots, cerebrospinal fluid, aqueous humour, synovial fluid, and epidermal micro-dialysis lysate – to name a few. The quantification of absorbed exogenous drugs into tissue, like vaginal biopsies and hair follicles, is also possible,” added Hiten. 

“And finally, multiple analyte analysis. In this case, the collected blood sample needs to be split into multiple aliquots for analysis, for example drug-drug interaction (DDI) studies with the Basel cocktail. The smaller sample volumes will allow more frequent sampling to be feasible and thus more accurate DDI interpretation,” Hiten explains.

“As a bio-analyst, one is seldom surprised. However, Aurora has already opened doors to new frontiers for our entire team and we cannot wait to do some more exploration,” says Hiten. 

To find out more about what Aurora and the FARMOVS team can do for your study, email business@farmovs.com

News Archive

UFS Ground Studies Laboratory receives accreditation to international standard
2016-03-18

Description: IGS Tags: IGS

Lore-Mari Deysel, Deputy-Director of the institute for Groundwater Studies.
Photo: Charl Devenish

The Institute for Groundwater Studies (IGS) Laboratory at the University of the Free State is on equal footing with international testing labs. With its accreditation in March 2016 by SANAS (South African National Accreditation System), the IGS Laboratory now officially meets global standards.

Quality of water

The IGS Laboratory mainly analyses the quality of water samples. When it was originally established in 1989, the lab’s central function was to conduct testing for researchers at the institute itself. “After the public and water boards realised their need to analyse water samples, the IGS Laboratory expanded to deliver a service to these clients,” says Lore-Mari Deysel, Deputy-Director of the institute.

Since suppliers and regulatory authorities will not accept test or calibration results from a lab that is not accredited, the IGS initiated the accreditation process.

Accreditation to international standard


In order to be deemed technically competent and able to receive accreditation, labs must meet the ISO/IEC 17025 standard. ISO/IEC 17025 was first issued in 1999 by the ISO (International Organization for Standardization) and the IEC (International Electrotechnical Commission).According to Deysel, this is the single most important standard for calibration and testing laboratories around the world.

“Laboratories that are accredited to this international standard have demonstrated that they are technically competent and able to produce precise and accurate test and/or calibration data. Furthermore, it demonstrates that the university has the capacity to supply valuable and reliable services alongside the academy,” Deysel says.

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