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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

Stem cell research and human cloning: legal and ethical focal points
2004-07-29

   

(Summary of the inaugural lecture of Prof Hennie Oosthuizen, from the Department of Criminal and Medical Law at the Faculty of Law of the University of the Free State.)

 

In the light of stem cell research, research on embryo’s and human cloning it will be fatal for legal advisors and researchers in South Africa to ignore the benefits that new bio-medical development, through research, contain for this country.

Legal advisors across the world have various views on stem cell research and human cloning. In the USA there is no legislation that regulates stem cell research but a number of States adopted legislation that approves stem cell research. The British Parlement gave permission for research on embryonic stem cells, but determined that it must be monitored closely and the European Union is of the opinion that it will open a door for race purification and commercial exploitation of human beings.

In South Africa the Bill on National Health makes provision for therapeutical and non therapeutical research. It also makes provision for therapeutical embryonical stem cell research on fetuses, which is not older than 14 days, as well as for therapeutical cloning under certain circumstances subject to the approval of the Minister. The Bill prohibits reproductive cloning.

Research on human embrio’s is a very controversial issue, here and in the rest of the world.

Researchers believe that the use of stem cell therapy could help to side-step the rejection of newly transplanted organs and tissue and if a bank for stem cell could be built, the shortage of organs for transplants would become something of the past. Stem cells could also be used for healing of Alzheimer’s, Parkinson’s and spinal injuries.

Sources from which stem cells are obtained could also lead to further ethical issues. Stem cells are harvested from mature human cells and embryonic stem cells. Another source to be utilised is to take egg cells from the ovaries of aborted fetuses. This will be morally unacceptable for those against abortions. Linking a financial incentive to that could become more of a controversial issue because the woman’s decision to abort could be influenced. The ideal would be to rather use human fetus tissue from spontaneous abortions or extra-uterine pregnancies than induced abortions.

The potential to obtain stem cells from the blood of the umbilical cord, bone-marrow and fetus tissue and for these cells to arrange themselves is known for quite some time. Blood from the umbilical cord contains many stem cells, which is the origin of the body’s immune and blood system. It is beneficial to bank the blood of a newborn baby’s umbilical cord. Through stem cell transplants the baby or another family member’s life could be saved from future illnesses such as anemia, leukemia and metabolic storing disabilities as well as certain generic immuno disabilities.

The possibility to withdraw stem cells from human embrio’s and to grow them is more useable because it has more treatment possibilities.

With the birth of Dolly the sheep, communities strongly expressed their concern about the possibility that a new cloning technique such as the replacement of the core of a cell will be used in human reproduction. Embryonic splitting and core replacement are two well known techniques that are associated with the cloning process.

I differentiate between reproductive cloning – to create a cloned human embryo with the aim to bring about a pregnancy of a child that is identical to another individual – and therapeutically cloning – to create a cloned human embryo for research purposes and for healing human illnesses.

Worldwide people are debating whether to proceed with therapeutical cloning. There are people for and against it. The biggest ethical objection against therapeutical cloning is the termination of the development of a potential human being.

Children born from cloning will differ from each other. Factors such as the uterus environment and the environment in which the child is growing up will play a role. Cloning create unique children that will grow up to be unique individuals, just like me and you that will develop into a person, just like you and me. If we understand this scientific fact, most arguments against human cloning will disappear.

Infertility can be treated through in vitro conception. This process does not work for everyone. For some cloning is a revolutionary treatment method because it is the only method that does not require patients to produce sperm and egg cells. The same arguments that were used against in vitro conception in the past are now being used against cloning. It is years later and in vitro cloning is generally applied and accepted by society. I am of the opinion that the same will happen with regard to human cloning.

There is an argument that cloning must be prohibited because it is unsafe. Distorted ideas in this regard were proven wrong. Are these distorted ideas justified to question the safety of cloning and the cloning process you may ask. The answer, according to me, is a definite no. Human cloning does have many advantages. That includes assistance with infertility, prevention of Down Syndrome and recovery from leukemia.

 

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