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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 to monitor the use of ARV-drugs on pregnant women and children
2004-12-08

The University of the Free State (UFS) is to establish a Pharmacovigilance Centre that will monitor the effects of Anti-Retroviral (ARV) drugs on HIV positive pregnant women and children starting early in the new year.

The UFS is one of only two institutions chosen by the Minister of Health, Dr Manto Tshabalala-Msimang, to establish such an ARV monitoring centre.

The other centre will be based at Medical University of South Africa (MEDUNSA) and will concentrate mainly on monitoring the effects of the drugs on adults.

“The establishment of the UFS’s Pharmaconvigilance Centre forms part of government’s Comprehensive Plan on HIV and AIDS, often termed the roll-out plan for ARV drugs. The centre’s primary responsibility will be to specifically monitor the use of these drugs in pregnant women, and children under the age of 13,” said Prof Andrew Walubo of the UFS’s Department of Pharmacology.

“Although most of the side effects of ARV drugs have been identified in other countries, it has now become critical to identify the side effects amongst the South African population. This is important because many people will be exposed to the drugs within a short time. Our aim is so identify the most common side effects and make recommendations for the prevention thereof. The centre will help in detecting the risk of using anti-retroviral drugs in pregnancy and children, and prevention of adverse drug reactions,” said Prof Walubo.

According to Prof Walubo 12 drugs will be monitored – these drugs will be selected according to the patient’s profile.

The centre will comprise of two components: A pregnancy registry, which will focus on a new-born child up until two months and a pediatric registry, which will focus on children who are born of mothers who used ARV drugs and children using ARV drugs.

According to Prof Walubo, the Pharmaconvigilance Centre will also be responsible for offering relevant technical advice, training and selected research on ARV drugs in these patients.

The centre will be fully sponsored by the national Department of Health. It will be based in the UFS’s Faculty of Health Sciences, Department of Pharmacology, and will be run in collaboration with experts from different departments in the faculty.

Media release
Issued by: Lacea Loader
Media Representative
Tel: (051) 401-2584
Cell: 083 645 2454
E-mail: loaderl.stg@mail.uovs.ac.za
8 December 2004

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