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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

Nuclear Medicine on the forefront of cancer research
2017-07-10

Description: Nuclear Medicine on the forefront of cancer research Tags: Nuclear Medicine, cancer research, Dr Je’nine Horn-Lodewyk’s, tumour detection method, cancer, Department of Nuclear Medicine 

Dr Je’nine Horn-Lodewyk’s tumour detection method
could be the cost-effective breakthrough needed to decrease
the mortality rate in breast cancer patients.
Photo: Anja Aucamp

The field of Nuclear Medicine in South Africa and the rest of the world are expanding rapidly due to the development of hybrid cameras and new radiopharmaceuticals. These developments have a huge impact on the diagnosis and therapy of cancer.

The most advanced of these cameras, Positron emission tomography combined with normal CTs (PETCT), are not yet widely available in South Africa due to the cost of the cameras and the radiopharmaceuticals. A more cost-effective alternative can be of great benefit. To achieve this, the focus should be on developing new radiopharmaceuticals that can be used with the current cost-effective gamma cameras, according to University of the Free State researcher, Dr Je’nine Horn-Lodewyk from the Department of Nuclear Medicine.

Fluorodeoxyglucose (18F-FDG), a radiolabelled glucose analogue, is currently the radiopharmaceutical most commonly used in PET/CT imaging for mainly oncology indications. Although it is considered the gold standard for imaging in several malignancies, it does have certain disadvantages. An 18F-FDG PET/CT diagnostic imaging study can cost between R25 000 and R35 000 for a single patient in the private sector. The 18F-FDG is also more radioactive, which requires much stricter handling and shielding to avoid high radiation dosages to staff and patients.

Successful research potential innovative solution
In the search for the ideal radiopharmaceutical for tumour detection, the South African National Nuclear Energy Corporation (Necsa) developed a local synthesis process for ethylenedicysteine-deoxyglucose (EC-DG). EC-DG is also a glucose analogue similar to FDG. They succeeded in labelling the compound with Technetium-99-metastable-pertechnetate (99mTcO4-), the most common nuclear medicine isotope used for approximately 95% of nuclear medicine procedures, creating 99mTc-EC-DG.

In partnership with Dr Horn-Lodewyk, this compound was successfully used in various animal models and clinical scenarios, resulting in approval by the Medicine Control Council to use it in a human study. Research is also planned in order to investigate diagnostic accuracy in other cancers like lymphoma.  The end result of this research can produce a radiopharmaceutical that is cost effective, does not require the use of costly specialised equipment, has no significant side-effects, no special patient preparation, renders late imaging possible, and has decreased radiation risks.

Dr Horn-Lodewyk is grateful for the support of her mentor, Prof Anton Otto, as well as Dr Gert Engelbrecht, Head of the Department of Nuclear Medicine, Prof Jan Rijn Zeevaart from North-West University’s Preclinical Drug Development Platform and Necsa, and Judith Wagener from Necsa. This innovative research would also not have been possible without the financial assistance of Dr Glen Taylor and Eleanor van der Westhuizen in the Directorate of Research Development.

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