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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

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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