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01 October 2021 | Story Lunga Luthuli and Vicky Simpson | Photo Supplied
Anton Engelbrecht _ Farmovs researcher
Anton Engelbrecht, FARMOVS Bioanalysis Specialist.

“At FARMOVS, we have the opportunity to work with the world’s top pharmaceutical companies, where we form part of the evaluation of labelled and/or conjugated antigens and antibodies that are developed for accurate quantification of endogenous and pharmaceutical compounds. Alternatively, commercially available kits and reagents are also used for the same purpose if the sponsor cannot supply the customised antigens/antibodies. The developed assay methods are put through a rigorous validation assessment to confirm the selectivity, sensitivity, and robustness of the assay,” says Anton Engelbrecht, FARMOVS Bioanalysis Specialist. 

FARMOVS, affiliated to the University of the Free State and operating from the Bloemfontein Campus, is a leading clinical research organisation (CRO) with a unique advantage. As the only on-site ISO15189-accredited and GLP-certified pharmacokinetic laboratory on the African continent, with numerous successful inspections by leading international regulators, it offers the highest quality bioanalytical services in a variety of biological matrices for the development of pharmaceutical products.

Engelbrecht says: “The team of bioanalytical experts thrives on the excitement generated by new discoveries that lead to better treatment of a variety of physiological diseases.”

Advanced technology backed by 47 years of bioanalytical experience

The clinical research organisation prides itself on advanced technology, backed by 47 years of bioanalytical experience. It has developed more than 580 validated analytical methods that adhere to the International Council for Harmonisation and the US Food and Drug Administration (FDA) guidelines. FARMOVS’ analytical methods have been used in more than 3 000 pre-clinical and clinical trials, contributing to the manufacturing of pharmaceutical drugs that are now used by households across the globe.

At FARMOVS, Engelbrecht says, it is a “world filled with novel methods of analysis and subsequent technological integration that expands the horizons of clinical research forming an important part of the discovery and production of new life-saving medicines that is constantly improving the quality of life of people all over the world”.

Engelbrecht says: “New technology and innovation should be the building blocks of any laboratory, and among these are the three fastest sample production members of our Immunochemistry Laboratory team – the STARLet pipettors.”

“We chose the Microlab® STARLet apparatus by Hamilton, because of its ability to perform sample analysis in large quantities at a greater speed by means of robotic pipetting and robotic automated microplate reading, which is a semi-automated process.”

He shared his excitement about improvements in the field of immunoassay development for the purposes of pharmaceutical analysis. This involves the preparation of unique immunoanalytical reagents, analysis of new categories of compounds, methodology, and instrumentation. The most important examples in this field are the continuous development of bead-based immunoassays.

Staying competitive in the industry

Immunoassay methods, such as radioimmunoassay (RIA) and enzyme immunoassay (EIA), among others, are also used at FARMOVS to analyse macromolecules for clients. “The RIA method is used for the determination of several pharmaceutically important compounds in biological fluids. RIA requires a sample containing the antigen of interest, a complementary antibody, and a radiolabelled version of the antigen. To increase the selectivity of an assay, all samples are pre-treated to eliminate high molecular weight endogenous matrix components, including anti-drug antibodies,” explains Engelbrecht.

Although FARMOVS has adequate technology to provide market-related results, the plan is to expand the team to include a multiplex platform that is a sensitive, fully automated immunoassay platform with multiplexing and custom assay capability. “This will pave the way to use an even more sensitive method to quantify biomarkers in the fields of oncology, neurology, cardiology, inflammation, and infectious disease. We aim to remain competitive in our industry, so naturally we must recruit the brightest and most evolved to join the team,” he says.

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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