Research development

API lab to accelerate drug research, development and commercialization

The Active Pharmaceutical Ingredient (API) Plus laboratory, launched by the Deputy Minister of Science and Innovation Buti Manamela March 11, is working with universities and other industry partners to develop new competitive API manufacturing processes, with the goal of building local API manufacturing capacity in South Africa.

One of the key outcomes of the API Technology Innovation Cluster is to develop improved, cost-competitive API synthesis demo packages that can be scaled up to commercial API manufacturing plants by industry partners, a said Manamela.

The API Plus lab is part of the API Technology Innovation Cluster, which is managed and overseen by 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 lab and its facilities are intended to assist in the development of flow processes for APIs, and all API cluster program 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 says.

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

In addition, the cluster is involved in a collaborative program with the Bill and Melinda Gates Foundation around an important antimalarial, underlined Du Plessis.

“In addition to funding research projects in South Africa, the cluster has helped set up the laboratory infrastructure, at Chemical Process Technology Pharmaceuticals (CPT Pharma), in Watloo, Pretoria.

“One of the important steps is the development of simpler and more cost-effective flow processes for the APIs of interest. We hope this lab will help multiply the impact of research and development in many other initiatives,” she said.

South Africa has a strong pharmaceutical formulation industry and formulates between 60% and 70% of all drugs used in the country. This provides a strong background in Good Manufacturing Practices (GMP) to formulate the ingredients and medicines that South Africa needs, as well as a strong ability to analyze and maintain end products, the director said. of CPT Pharma, Dr. Gerrit van der Klashorst.

“On the other hand, when it comes to manufacturing APIs, which are the active ingredients in pharmaceuticals, we have very limited capacity and import over R20 billion a year of APIs,” he said. -he declares.

The vision of the API cluster is to establish an innovative, competitive and world-class API manufacturing facility, not only for South Africa, but within the African context, which has experienced supply restrictions and disruptions in drugs, vaccines and reagents to carry out tests during the period affected by the Covid-19 pandemic, he said, echoing an earlier point from the director of international business development at the South African Research Council physician and principal professor of the API cluster Richard Gordon.

“The approach is to exploit the [intellectual property]not only small businesses, but also academic and higher education institutions and their capacity in terms of process development, and to use and test this technology and introduce it into the API synthesis forum” , said Van der Klashorst.

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

“The API lab will take these new types of developed high-yield processes and translate them into high-yield commercial processes for isolates,” he illustrated.

GOVERNMENT STRATEGY
Furthermore, Manamela said South Africa’s marginal local manufacturing of pharmaceuticals and reliance on imports come at the expense of the health security of its citizens.

“Local manufacturing of APIs has been a priority in the country with the large-scale roll-out of ARVs for the treatment of HIV and AIDS, and South Africa is one of the largest buyers of ARVs in the world “, did he declare.

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

“We believe this has given heightened importance to the need to harness investments from private and non-governmental organizations as a means to strengthen our scientific and technological skills and thereby improve our ability to address certain health challenges, including those related to the HIV, tuberculosis and malaria,” says Manamela.

The country’s strength in the supply of APIs and in the packaging, labeling, distribution and sale of pharmaceuticals has not translated into the manufacturing strength of APIs.

The National Bioeconomy Strategy of the Department of Science and Innovation has among its objectives the goal of strengthening research, development and local manufacturing capacity for APIs, vaccines, biopharmaceutical diagnostics, prophylactics and medical devices to address the disease burden and ensure security and sustainability of supply, he mentioned.

“The establishment of the API cluster should be seen as the implementation of the country’s bioeconomy strategy and the goal of developing the South African health economy by providing locally developed APIs, diagnostics and medical devices and relevant, and to develop their production.

“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 drugs 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 basket of incentives offered to potential investors to address key investment decision factors, including, for example, security of levies, skills incentives, expatriate support and capital-intensive investments. reimbursement schemes, he added.

“South Africa must continue to invest in establishing local API manufacturing capacity much more vigorously, as it has many direct and indirect benefits, including industry growth and direct creation of highly skilled jobs. “, did he declare.