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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

Research into surrogate milk important to wildlife conservation
2017-05-08

Description: Prof Garry Osthoff Tags: Prof Garry Osthoff

Prof Gary Osthoff from the UFS Department of
Microbial, Biochemical and Food Biotechnology,
will soon work on a milk formula for elephants.
Photo: Supplied

Research is being done at the University of the Free State (UFS) to analyse and synthetically imitate the unique milk of various wildlife species. This research is not only of scientific value, but also serves the conservation of South Africa’s wildlife species. At the forefront of this research is Prof Garry Osthoff from the Department of Microbial, Biochemical and Food Biotechnology.

Orphaned rhino calf pulled through with surrogate milk
“There is still a lot of research to be done. Naturally the research is of scientific importance, but with surrogate milk having the same composition as the mother’s milk of a specific species, orphaned calves or cubs of that species could be pulled through during a difficult time of weaning. Bearing in mind that exotic animals fetch thousands and even millions of rands at auctions, it goes without saying a game farmer will do everything possible to provide only the best nourishment to such an orphaned animal. In such a case, synthetically-manufactured milk would be the right choice,” says Prof Osthoff.

The fruits of his research were recently demonstrated in Germany when a rhino calf was left orphaned in the Leipzig Zoo. Prof Osthoff’s article: “Milk composition of a free-ranging white rhinoceros during late lactation” was used as a directive for applying surrogate milk for horse foals (which is already commercially available), since the composition of horse and rhino milk largely corresponds. The surrogate milk was used with great success and the rhino calf is flourishing. He mentions that such an orphan is often given the wrong nourishment with the best intentions, resulting in the starvation of the animal despite the amount of cow’s milk it devours.

With surrogate milk having the same
composition as the mother’s milk of a
specific species, orphaned calves or
cubs of that species could be pulled
through during the difficult time
of weaning.

Milk formula for baby elephants in the pipeline
With baby elephants left orphaned due to the increase in elephant poaching for their ivory, several attempts have been made to create a milk formula in order to feed these elephants. To date, many elephants have died in captivity from side effects such as diarrhoea as a result of the surrogate formula which they were fed.

Prof Osthoff recently received a consignment of frozen milk which he, together with researchers from Zimbabwe, will use to work on a milk formula for elephants. They are studying the milk in a full lactation period of two years. During lactation, the composition of the milk changes to such an extent that a single surrogate formula will not be sufficient. Four different formulas should probably be designed.

Prof Osthoff says that of the different species he has researched, elephants are the most interesting and deviate most from the known species.

Although his research to develop surrogate milk is adding much value to the wildlife industry, and although he finds this part of his work very exciting, his research focus is on food science and nutrition. “What is currently authentic in milk research is the study of the fat globules with content, the structure and composition of the casein micelle, and the prebiotic sugars. The knowledge which is gained helps to improve the processing, development of new food products, and development of food products for health purposes,” says Prof Osthoff.

 

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