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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

Champagne and cancer have more in common than you might think
2013-05-08

 

Photo: Supplied
08 May 2013

No, a glass of champagne will not cure cancer....

…But they have more in common than you might think.

Researchers from the Departments of Microbial Biochemical and Food Biotechnology, Physics and the Centre for Microscopy at the University of the Free State in South Africa were recently exploring the properties of yeast cells in wine and food to find out more of how yeast was able to manufacture the gas that caused bread to rise, champagne to fizz and traditional beer to foam. And the discovery they made is a breakthrough that may have enormous implications for the treatment of diseases in humans.

The team discovered that they could slice open cells with argon gas particles, and look inside. They were surprised to find a maze of tiny passages like gas chambers that allowed each cell to ‘breathe.’ It is this tiny set of ‘lungs’ that puts the bubbles in your bubbly and the bounce in your bread.

But it was the technique that the researchers used to open up the cells that caught the attention of the scientists at the Mayo Clinic (Tumor Angiogenesis and Vascular Biology Research Centre) in the US.

Using this technology, they ultimately aim to peer inside cells taken from a cancer patient to see how treatment was progressing. In this way they would be able to assist the Mayo team to target treatments more effectively, reduce dosages in order to make treatment gentler on the patient, and have an accurate view of how the cancer was being eliminated.

“Yes, we are working with the Mayo Clinic,” said Profes Lodewyk Kock from the Microbial, Biochemical and Food Biotechnology Department at the UFS.

“This technique we developed has enormous potential for cell research, whether it is for cancer treatment or any other investigation into the working of cells. Through nanotechnology, and our own invention called Auger-architectomics, we are able to see where no-one has been able to see before.”

The team of Prof Kock including Dr Chantel Swart, Kumisho Dithebe, Prof Hendrik Swart (Physics, UFS) and Prof Pieter van Wyk (Centre for Microscopy, UFS) unlocked the ‘missing link’ that explains the existence of bubbles inside yeasts, and incidentally have created a possible technique for tracking drug and chemotherapy treatment in human cells.

Their work has been published recently in FEMS Yeast Research, the leading international journal on yeast research. In addition, their discovery has been selected for display on the cover page of all 2013 issues of this journal.

One can most certainly raise a glass of champagne to celebrate that!

There are links for video lectures on the technique used and findings on the Internet at:

1. http://vimeo.com/63643628 (Comic version for school kids)

2. http://vimeo.com/61521401 (Detailed version for fellow scientists)

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