The Department of Science and Innovation (DSI) has invested R15 million towards the establishment of the Active Pharmaceutical Ingredient (API) technology innovation facility.
The laboratory is funded through its innovation entity, the Technology Innovation Agency (TIA).
The project is a joint initiative between the DSI and North-West University (NWU), together with academia and the medical and ICT industries.
According to the DSI, the initiative forms part of the newly-established API Cluster, which will drive technology development and commercialisation of local API manufacturing, focusing on the synthesis of small molecule APIs for human health, using modern manufacturing technology.
The laboratory is based in Watloo, Pretoria, and will develop innovative and competitive processes to manufacture APIs, with the aim of creating local capacity for API manufacturing in South Africa. This initiative is set to save the country billions of rands presently spent on APIs, it says.
Speaking at the recent launch, higher education, science and innovation deputy minister Buti Manamela said the manufacturing of APIs has been a priority for government since the large-scale roll-out of antiretroviral (ARV) drugs for those living with HIV and Aids, which constituted a huge part of national health expenditure.
"It therefore goes without saying that reliance on the importation of finished drugs or the APIs not only burdens the country with a security of supply risk, but also results in a significant trade deficit for the pharmaceutical sector," he said.
“This initiative forms part of the national bio-economy strategy – the strategy's initiative for health, to support and strengthen local research, development and innovation capabilities to manufacture APIs, vaccines, bio-pharmaceuticals, diagnostics and medical devices to address the country's disease burden.”
APIs are the biologically active components in a pharmaceutical drug which are formulated with other ingredients to make finished pharmaceutical products, such as tablets and capsules. It costs SA R15 billion a year to import a vast majority of the APIs used to formulate medicines in local plants, notes DSI.
This dependence has, at times, led to import and distribution problems.
Furthermore, the industry is often marred with restrictions and disruptions of supplies of medicines, vaccines and reagents to conduct tests, as well as the lack of tracking tools to monitor supply chain processes, it says.
The API Cluster is also set to stimulate industry competitiveness by leveraging existing skills, technologies and facilities available in South Africa. Its foundation will be an aggressive locally-developed technology strategy that can be used to leverage collaboration and partnerships in the pharmaceutical sector, addedManamela.
The goal is to develop Drug Master Files (documents prepared by a pharmaceutical manufacturer) for the competitive manufacturing of targeted APIs and to leverage this to set up a commercial pipeline for local API manufacturing.
Also speaking at the launch, NWU vice-chancellor professor Linda du Plessis pointed out the API Cluster is involved in several research projects.
“These projects included using enzymes to produce building blocks for anti-retrovirals (ARVs) in partnership with Wits University, and synthesising angiotensin receptor blockers using myosynthesised nanoparticles to catalyse the process in collaboration with the University of the Western Cape.”
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