The Active Pharmaceutical Ingredient (API) Plus laboratory, launched by Science and Innovation Deputy Minister Buti Manamela on March 11, is working with universities and other industry partners to develop novel and competitive processes to manufacture APIs, with the aim of creating local capacity for API manufacture in South Africa.

A key output of the API Technology Innovation Cluster is to develop cost-competitive and improved API synthesis demonstration packages that can be scaled up to commercial API manufacturing plants by industry partners, Manamela said.

The API Plus laboratory is part of the API Technology Innovation Cluster, which is managed and overseen by the North-West University (NWU), and which collaborates with all local universities and research institutions. It is available to all partners and stakeholders, including students and researchers, says NWU acting Vice Chancellor Professor Linda du Plessis.

"The laboratory and its equipment is aimed at assisting in the development of flow processes for APIs, and all API cluster programme associates have access to these facilities," she said.

"Currently, the API cluster is involved in several research projects, which will be complemented by additional projects over time. The projects include the use of enzymes to produce building blocks for antiretrovirals (ARVs) in collaboration with [the University of the Witwatersrand (Wits)}, and synthesising angiotensin receptor blockers using myosynthesised nanoparticles to catalyse the process in collaboration with the [University of the Western Cape]," she said.

The cluster is also involved in flow process development for antiparasitics in collaboration with the University of Pretoria; the development of a commercial manufacturing process for ARVs in collaboration with Wits; and the development of a cost-effective continuous flow synthesis of antimalarials, in collaboration with the Nelson Mandela University.

Further, the cluster is involved in a collaborative programme with the Bill and Melinda Gates Foundation around an important antimalarial, Du Plessis highlighted.

"In addition to funding research projects in South Africa, the cluster was instrumental in assisting with the set-up of the laboratory infrastructure, at Chemical Process Technology Pharmaceuticals (CPT Pharma), in Watloo, Pretoria.

"One of the important milestones is the development of simpler and more cost-effective flow processes for the APIs of interest. We hope that this laboratory will help to multiply the impact of research and development into many other initiatives," she said.

South Africa has a strong pharmaceutical formulation industry and formulates between 60% and 70% of all the medicinal products used in the country. This provides a strong Good Manufacturing Practices (GMP) background to formulate the ingredients and medicinal products South Africa needs, as well as strong capacity to analyse and sustain final products, said CPT Pharma director Dr Gerrit van der Klashorst.

"On the other hand, when it comes to API manufacturing, which are the active ingredients in pharmaceutical products, we have very limited capacity and import more than R20-billion a year of APIs," he said.

The vision of the API cluster is to establish an innovative, competitive and world-class API manufacturing facility, not only for South Africa, but in the African context, which experienced restrictions and disruptions of supplies of medicines, vaccines and reagents to conduct tests during the Covid-19 pandemic-impacted period, he said, echoing an earlier point by South African Medical Research Council international business development director and API Cluster lead Professor Richard Gordon.

"The approach is to harness the [intellectual property], not only of smaller companies, but also in academic and higher education institutions and their capacity in terms of process development, and to use and test that technology and bring it into the forum of API synthesis," said Van der Klashorst.

The API Plus laboratory will work to transition these novel technologies into good manufacturing processes and commercial manufacturing processes.

"The API Lab will take those novel types of developed processes that are high yielding and translate them into commercial, high-isolate-yielding processes," he illustrated.

GOVERNMENT STRATEGY
Further, Manamela said South Africa's marginal local manufacturing of pharmaceuticals and dependence on imports comes at the cost of the health security of its citizens.

"Local manufacturing of APIs has been a priority in the country with the large-scale rollout of ARVs for the treatment of HIV and Aids, and South Africa is one of the largest procurers of ARVs worldwide," he said.

The World Health Organisation recently released new guidelines for HIV and tuberculosis (TB) treatments and a number of innovations in this area.

"We believe this has placed increased significance on the need to harness investment by private and nongovernmental organisations as a way to strengthen our scientific and technological competencies and thereby enhance our capacity to address some health challenges, including relating to HIV, TB and malaria," said Manamela.

The country's strength in API procurement and in the packaging, labelling, distribution and sale of pharmaceuticals has not translated into API manufacturing strength.

The Department of Science and Innovation national bioeconomy strategy has among its objectives the aim to strengthen local research, development and capacity to manufacture APIs, vaccines, biopharmaceutical diagnostics, prophylactics and medical devices to address the disease burden and ensure security and sustainability of supply, he said.

"The setting up of the API cluster must be viewed as implementation of the country's bioeconomy strategy and the goal of growing the South African health economy by providing locally developed and relevant APIs, diagnostics and medical devices, and to grow the manufacturing thereof.

"For API manufacturing to be viable and sustainable in the country, we need to develop world-class pharmaceutical manufacturing technology with the supporting skills so that we can produce APIs and finished medicines by local companies and for the regional export market," said Manamela.

For the API Technology Innovation Cluster model to be sustainable, there needs to be a much more attractive incentive basket offered to prospective investors to address key investment decision drivers, including, for example, security of offtake, skills incentives, expatriate support and capital intensive investment rebate schemes, he added.

"South Africa must pursue investment to establish local API manufacturing capability much more vigorously, as it has many direct and indirect benefits, including the growth of the industry and the direct creation of highly skilled jobs, he said.