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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

SADoCoL receives partial reinstatement of blood sample testing by the World Anti-Doping Agency
2016-08-22

Last week, the World Anti-Doping Agency (WADA) announced the lifting of the suspension of blood sample analysis by the South African Doping Control Laboratory (SADoCoL) at the University of the Free State (UFS). Although the suspension of urine sample analysis is still under review, the UFS is appreciative of the new outcome. The initial temporary suspension of SADoCoL, announced on 3 May 2016, included the suspension of all doping-control procedures which applied to both urine and blood samples.

The main reason for the suspension involved analytical techniques relevant to urine analysis; however, the testing of blood samples was also included in the suspension. At the time of the suspension, no adverse findings were reported for the laboratory in relation to blood-sample testing for Athlete Blood Passport (ABP) assessment. 

According to the agreement with WADA, the suspension period would be utilised to implement and test new systems in order to achieve the standard presently required by WADA, as well as to perform development and improvements. SADoCoL is a specialised service laboratory of the UFS and has been in existence for more than thirty years.

Upon SADoCoL’s request to lift the suspension of only the ABP analysis, WADA agreed to allow the laboratory to apply for reaccreditation.  SADoCoL immediately applied for reaccreditation of ABP analysis on blood, so that the laboratory would be allowed to at least offer this service to the Anti-Doping community in Africa.

For this purpose, inspections were performed by the South African National Accreditation System (SANAS) and by WADA, during which all aspects of blood analysis by the laboratory were thoroughly assessed and tested.  The successful outcome of these inspections resulted in the reaccreditation of SADoCoL by WADA in order to perform ABP analysis as required by the WADA International Standard for Laboratories, with effect from 4 August 2016. 

This outcome allows the laboratory to once again perform this very essential analytical procedure.  The South African Institute for Drug-Free Sport (SAIDS) and other regular users can now continue to send blood samples to SADoCoL for ABP analysis, instead of making use of alternative laboratories.

 

Released by: Lacea Loader (Director: Communication and Brand Management)
Tel: +27 51 401 3422/2707 or +27 83 645 2454
Email: news@ufs.ac.za  | loaderl@ufs.ac.za
Fax: +27 51 444 6393

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