Rubic One Health (ROH) intends to establish a cutting-edge vaccine manufacturing facility at the Coega Special Economic Zone (SEZ) in Gqeberha in the Eastern Cape.
The initiative will result in the production of affordable and accessible vaccines for animals and humans that are suitable for African conditions.
The one health approach recognises the inter-connectedness between animals, humans and the shared environment. Zoonotic diseases have a serious impact on human health. Thus, preventing diseases in animals results in a decrease in illnesses in humans.
Dr Julian Naidoo, the CEO of ROH, explains that 60% of human diseases are zoonotic.
The facility will operate in adherence to Current Good Manufacturing Practice regulations and is expected to produce 27 million doses per annum.
ROH and the African Export-Import Bank on Monday signed an agreement to fund the vaccine manufacturing initiative’s project preparation facility, which, according to Naidoo, will serve as a catalyst to complete the work needed to take the project to full bankability. It is hoped that the commissioning of the manufacturing plant will take place within the next 12 to 18 months.
Addressing vaccine access in Africa
According to the initiative’s promoters – consisting of leading scientists, economists, regulatory experts, business leaders, and academics – ROH is the coming together of academics and businesses to address the challenge of Africa’s access to vaccines.
The promoters realised early in the Covid-19 pandemic that there is significant vaccine inequity in Africa, with the continent importing over 96% of its vaccines.
As a result, ROH developed a business model to make vaccines accessible to African countries and other under-served areas. Its core mandate is to create cost-effective vaccine solutions that improve access to locally manufactured vaccines, says Naidoo.
ROH’s chairperson Dr Mathews Phosa says the model is structured to build scientific and manufacturing capacity in Africa.
“We have developed a hub and spoke model, and we intend to leverage capability from experts in North, East, West, Central, and Southern Africa. In this way, we will add to the Africa Union’s mission to build regional capabilities.”
Phosa says the project is aligned to the African Continental Free Trade Area agreement. “We believe this project will stimulate economic linkages and local economic development in many countries,” he adds.
Developing and owning vaccine IP
The initiative also aims to locally develop and own vaccine discovery, development, and the formulation of intellectual property (IP).
“ROH intends to be one of the first African vaccine manufacturers to develop and own IP across the full value chain and not be dependent on Big Pharma,” says Naidoo.
What makes the ROH initiative different?
- ROH will participate in the full value chain, namely discovery, development, formulation, fill and finish, and manufacturing. While there is growing fill and finish capacity in Africa, there’s a huge gap in the manufacturing of antigens (drug substances), says Naidoo.
- “We have an aggressive skills development and skills transfer programme with a major international industry partner to ensure that our local engineering and manufacturing capabilities are achieved within the first three to five years of operation,” adds Phosa.
- The technology to be used will enable the project to produce vaccines quicker, safer, and cheaper. According to Naidoo, this is a game changer in the vaccine manufacturing space.
- ROH has an expanded licence to use the C1 fungal expression system for the development of animal and human vaccines and therapeutics. C1 is a protein production platform that can deliver more doses more affordably.
- The vaccines produced using C1 are safer (no endotoxins, etc) and better suited for African conditions as they do not need ultra-cold storage. “This will save countries significant amounts in cold storage and help distribute vaccines safely in remote and rural areas,” says Phosa.
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