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13 May 2019 | Story Zama Feni | Photo Charl Devenish
Dr Quinton Meyer and Marlena Visagie
National Control Laboratory Deputy Director, Dr Quinton Meyer (right), and Marlena Visagie, Quality Assurance Manager, at the laboratory within their facilities at the University of the Free State.

The University of the Free State-based National Control Laboratory for Biological Products (NCL) has maintained its esteemed status as a pharmaceutical testing laboratory after the South African Accreditation System (SANAS) further endorsed its quality-management systems as of high standard according to the International Standards Organisation’s requirements.

The Director of the NCL, Professor Derek Litthauer, said their laboratory – which is also approved by the World Health Organisation (WHO) – has again achieved the international testing standards. The cherry on top was that the NCL also received a certificate of Good Manufacturing Compliance (GMP) from the South African Health Products Regulatory Authority (SAHPRA). 

NCL is for Africa and the World 

Some of the factors that make the NCL an esteemed institution, is the fact that it is one of 12 laboratories worldwide to perform vaccine testing for the WHO; the NCL is the only vaccine-testing laboratory in the country that performs the final quality-control testing of all human vaccine batches marketed in South Africa on behalf of SAHPRA. 

For example, Prof Litthauer said that the influenza vaccine batches currently available on the South African market, were tested by the NCL for quality before authorising their release for sale to the public. This process is followed for all human vaccines used in SA.

 “In our role as vaccine-testing laboratory for the WHO, the NCL helps to ensure that the vaccines purchased through the WHO prequalification programme for international distribution to resource-limited countries, meet the high standards of quality, safety, and efficiency. 
The NCL was one of the first full members of the WHO NCL Network for Biologicals, which consists of full and associate members of regulatory authorities from more than 30 countries.

The NCL systems are world-class

Prof Litthauer said this achievement is recognition that their laboratory complies with specific international standards with respect to its quality-management system. 
“In practice, it means that the laboratory has all the quality systems in place to ensure high-quality test results. The GMP certification is a further step, meaning that laboratory testing is on the expected level for any pharmaceutical testing laboratory and manufacturer. It is a very strict certification.”

He further mentioned that the NCL is also licensed as a pharmaceutical manufacturer. “Although we do not manufacture, we have to comply with manufacturing standards.”
“It is rare for a pharmaceutical testing laboratory (such as the NCL) outside of a manufacturing context to qualify for both certifications. It means that the NCL complies with exceptionally strict standards for pharmaceutical labs anywhere in the world,” he said.
The certification provides the South African Health Products Regulatory Authority, the World Health Organisation, and other national control laboratories around the world, with the confidence that the test results from the NCL can be trusted.


There can be no compromise for quality 

The NCL Quality Assurance Manager, Mrs Marlena Visagie, said, “It is essential that the NCL complies with the highest international quality-assurance standards to ensure that all the lot-release operations, such as manufacturing review and quality testing, are performed in a reliable and reproducible manner.”

“There can be no compromise when it comes to the quality of medicines which are made available to the public,” she said.

“What makes this special, is that the NCL does not only comply with international ISO/IEC standards for pharmaceutical testing, but also with the additional GMP standards required by a pharmaceutical manufacturer. This means that the NCL must ensure that all its operations, including everything from the way documents are compiled and stored, to the maintenance of equipment and infrastructure as well as staff competency, are performed according to international guidelines.”

All NCL staff share vision of excellence

Prof Litthauer said the NCL has a staff complement of 15 technical, administrative, and support staff.  Four staff members have PhDs, and the rest of the technical staff have master’s or bachelor’s degrees or are trained as medical technologists. “At the moment, our biggest problem is to get enough suitable space to expand our testing,” he said.

Prof Litthauer said, “All the staff members at the NCL share the vision of excellence, which makes this kind of achievement possible.”
The NCL will host the third annual meeting of the WHO NCL Network in November of this year and will then be reassessed again by the WHO as part of the normal three-year cycle of assessments.  

News Archive

Fight against Ebola virus requires more research
2014-10-22

 

Dr Abdon Atangana
Photo: Ifa Tshishonge
Dr Abdon Atangana, a postdoctoral researcher in the Institute for Groundwater Studies at the University of the Free State (UFS), wrote an article related to the Ebola virus: Modelling the Ebola haemorrhagic fever with the beta-derivative: Deathly infection disease in West African countries.

“The filoviruses belong to a virus family named filoviridae. This virus can cause unembellished haemorrhagic fever in humans and nonhuman monkeys. In literature, only two members of this virus family have been mentioned, namely the Marburg virus and the Ebola virus. However, so far only five species of the Ebola virus have been identified, including:  Ivory Coast, Sudan, Zaire, Reston and Bundibugyo.

“Among these families, the Ebola virus is the only member of the Zaire Ebola virus species and also the most dangerous, being responsible for the largest number of outbreaks.

“Ebola is an unusual, but fatal virus that causes bleeding inside and outside the body. As the virus spreads through the body, it damages the immune system and organs. Ultimately, it causes the blood-clotting levels in cells to drop. This leads to severe, uncontrollable bleeding.

Since all physical problems can be modelled via mathematical equation, Dr Atangana aimed in his research (the paper was published in BioMed Research International with impact factor 2.701) to analyse the spread of this deadly disease using mathematical equations. We shall propose a model underpinning the spread of this disease in a given Sub-Saharan African country,” he said.

The mathematical equations are used to predict the future behaviour of the disease, especially the spread of the disease among the targeted population. These mathematical equations are called differential equation and are only using the concept of rate of change over time.

However, there is several definitions for derivative, and the choice of the derivative used for such a model is very important, because the more accurate the model, the better results will be obtained.  The classical derivative describes the change of rate, but it is an approximation of the real velocity of the object under study. The beta derivative is the modification of the classical derivative that takes into account the time scale and also has a new parameter that can be considered as the fractional order.  

“I have used the beta derivative to model the spread of the fatal disease called Ebola, which has killed many people in the West African countries, including Nigeria, Sierra Leone, Guinea and Liberia, since December 2013,” he said.

The constructed mathematical equations were called Atangana’s Beta Ebola System of Equations (ABESE). “We did the investigation of the stable endemic points and presented the Eigen-Values using the Jacobian method. The homotopy decomposition method was used to solve the resulted system of equations. The convergence of the method was presented and some numerical simulations were done for different values of beta.

“The simulations showed that our model is more realistic for all betas less than 0.5.  The model revealed that, if there were no recovery precaution for a given population in a West African country, the entire population of that country would all die in a very short period of time, even if the total number of the infected population is very small.  In simple terms, the prediction revealed a fast spread of the virus among the targeted population. These results can be used to educate and inform people about the rapid spread of the deadly disease,” he said.

The spread of Ebola among people only occurs through direct contact with the blood or body fluids of a person after symptoms have developed. Body fluid that may contain the Ebola virus includes saliva, mucus, vomit, faeces, sweat, tears, breast milk, urine and semen. Entry points include the nose, mouth, eyes, open wounds, cuts and abrasions. Note should be taken that contact with objects contaminated by the virus, particularly needles and syringes, may also transmit the infection.

“Based on the predictions in this paper, we are calling on more research regarding this disease; in particular, we are calling on researchers to pay attention to finding an efficient cure or more effective prevention, to reduce the risk of contamination,” Dr Atangana said.


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