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11 February 2021 Photo UFS photo archive
The National Control Laboratory for Biological Products (NCL) Building.

There can be no compromise when it comes to the quality of medicines made available to the public.

The UFS-based National Control Laboratory for Biological Products (NCL) is a full member of the international WHO-National Control Laboratory Network for Biologicals and one of 12 laboratories worldwide contracted to perform vaccine testing for the World Health Organisation (WHO). The NCL is also 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 the South African Health Products Regulatory Authority (SAHPRA).

In its role as a 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. 

International testing standards

The laboratory received the status of a pharmaceutical testing laboratory after the South African Accreditation System (SANAS) endorsed its quality-management systems as of a high standard according to the International Standards Organisation’s requirements.

With its international testing standards, the NCL must ensure that all its operations – 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.

The laboratory has all the quality systems in place to ensure high-quality test results. The certificate of Good Manufacturing Compliance received in 2019 indicates that laboratory testing is on the expected level for any pharmaceutical testing laboratory and manufacturer. This certification is very strict and means that the NCL complies with exceptionally strict standards for pharmaceutical labs anywhere in the world. The certification offers the South African Health Products Regulatory Authority, the WHO, and other national control laboratories around the world the confidence that the test results from the NCL can be trusted.

Licensed as pharmaceutical manufacturer

The laboratory is also licensed as a pharmaceutical manufacturer. Although the lab does not manufacture, it needs 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.

News Archive

Link between champagne bubbles and the UFS?
2012-11-16

Prof. Lodewyk Kock with an example of a front page of the publication FEMS Yeast Research, as adapted by F. Belliard, FEMS Central Office.
Photo: Leatitia Pienaar
15 November 2012

What is the link between the bubbles in champagne and breakthrough research being done at the Mayo Clinic in America? Nano research being done at our university.

Prof. Lodewyk Kock of Biotechnology says a human being consists of millions of minute cells that are invisible to the eye. The nano technology team at the UFS have developed a technique that allows researchers to look into such a cell, as well as other microorganisms. In this way, they can get an idea of what the cell’s “insides” look like.

The UFS team – consisting of Profs. Kock, Hendrik Swart (Physics), Pieter van Wyk (Centre for Microscopy), as well as Dr Chantel Swart (Biotechnology), Dr Carlien Pohl (Biotechnology) and Liza Coetsee (Physics) – were amazed to see that the inside of cells consist of a maze of small tunnels or blisters. Each tunnel is about 100 and more nanometres in diameter – about one ten thousandth of a millimetre – that weaves through the cells in a maze.

It was also found that these tunnels are the “lungs” of the cells. Academics doing research on yeast have had to sit up and take notice of the research being done at the UFS – to the extent that these “lungs” will appear on the front page of the highly acclaimed FEMS Yeast Research for all of 2013.

The Mayo Clinic, in particular, now wants to work with the UFS to study cancer cells in more detail in order to fight this disease, says Prof. Kock. The National Cancer Institute of America has also shown interest. This new nano technology for biology can assist in the study and development of nano medicine that can be used in the treatment of cancer and other life threatening diseases. Nano medicine uses nano metal participles that are up to one billionth of a metre in size.

Prof. Kock says laboratory tests indicate that nano medicine can improve the efficacy of anti-cancer medicine, which makes the treatment less toxic. “According to the Mayo Clinic team, nano particles are considered as a gold cartridge which is being fired directly at a cancer tumour. This is compared to fine shot that spreads through the body and also attacks healthy cells.”

“This accuracy implies that the chemotherapy dose can be lowered with fewer side effects. The Mayo Clinic found that one-tenth of the normal dosage is more effective against pancreas cancer in this way than the full dosage with a linkage to nano particles. According to the clinic, this nano medicine could also delay the spread of cancer,” says Prof. Kock.

The nano particles are used as messengers that convey anti-cancer treatment to cancer cells, where it then selectively kills the cancer cells. The transport and transfer of these medicines with regard to gold nano particles can be traced with the UFS’s nano technology to collect more information, especially where it works on the cell.

“With the new nano technology of the UFS, it is possible to do nano surgery on the cells by slicing the cells in nanometre thin slices while the working of the nano medicine is studied. In this way, it can be established if the nano medicine penetrates the cells or if it is only associated with the tiny tunnels,” says Prof. Kock.

And in champagne the small “lungs” are responsible for the bubbles. The same applies to beer and with this discovery a whole new reach field opens for scientists.

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