Accelerating supplies of rapid diagnostic test kits
Our insight of the week - July 24, 2020
University of Cape Town with Table Mountain, photo Adobe Stock
Here's what happened in recent months at Cape Bio Pharms. It is now two months since we last spoke to Belinda and Tamlyn Shaw, co-founders of Cape Bio Pharms in South Africa, but Spring already feels more like a year or more ago. In the COVID-19 pandemic, history is made every day.
In the meantime countries around the world have entered and exited confinement or near as damn it: In New Zealand there are still virtually no new cases since quite some time, in Europe countries are using color codes to mark the regions that are safe for travel or not, the U.S. is “recovering” from the initial surge in New York.
The global epicenters in Wuhan, Lombardy and New York have indeed diminished. On July 24, though, WHO has reported the highest number of new cases per day ever, resulting from massive growth in the United States, Middle- and South America, in the Asia-Pacific region as well as in sub-Saharan Africa. And the coronavirus knows no borders: there are over 15.5 million confirmed cases so far and over 630,000 deaths worldwide (July 25, 2020, Source: WHO) as the deadly virus spreads, while research on the long-term effects of virus raises concerns.
In sub-Saharan African countries, transmission is accelerating thanks to the lack of proper sanitary capacity but also insufficient data that could show where the hotspots are and where to focus action. Public health authorities could make more informed decisions if they had a footprint of where the novel coronavirus is or has been.
Belinda, CEO of Cape Bio Pharms, is utterly versed in COVID-19's evolution and how “developing countries are often at the end of the queue” when it comes to availability of new drugs, vaccine manufacturing and trials as well as any policy measures or tools that high-income countries have already been deploying. We know there are 626 unique therapeutic and vaccine candidates in development, of which 223 are in clinical trials – almost entirely in the industrialized world though South Africa is home to two vaccine trials.
Francisco Pera, Tamlyn Shaw, Belinda Shaw, Scott de Beer, photo courtesy Cape Bio Pharms (Pty) Ltd.
Changing the world
The team at Cape Bio Pharms is determined to change that. They have been perfecting their plant-based proteins used in rapid diagnostic test kits that are able to detect antibodies and confirm if a person has been in contact with the virus.
Ever since we last spoke Cape Bio Pharms has been working intensely to increase output yields through optimising their indoor hydroponic systems, protein purification and scaling up: they can now produce gram quantities of protein instead of milligrams. For manufacturers in the area this is manna from heaven. What's more, the tests that use Cape Bio's plant proteins have outperformed many other diagnostics tests, with their S1-His protein achieving specificity of 100% and sensitivity of 94% (IgM) and 100% (IgG) so far.
Now it’s up to SAHPRA, the South African Health Products Regulatory Authority, to give the green light so that the tests can be finally used in South Africa, the last step before starting distribution in the wider region. The government is also providing funds to help boost production of diagnostic reagents.
Young plants @Cape Bio Pharms, Cape Town, photo courtesy Cape Bio Pharms (Pty) Ltd.
“We want to provide community scale testing for Africa, to make it available as widely and as affordably as possible.” says Belinda. Nowadays, the price of tests can range from $20 to as much as $850 in the U.S. which is unaffordable even for them. Belinda is examining options to bring the price of the tests down even further to below two dollars, obviously a more bearable cost.
Her company is also exploring other opportunities and needs. “Even if we are still waiting for deployment in Africa, we are not stopping here,” she says. “We are discussing with manufacturers in India, who we all know have great production capacity, but also a real need for affordable and well-performing tests in large quantities. We wish to support them because it is crucial to counter the spread of COVID-19 as soon as possible”.
Meanwhile, daughter Tamlyn, Director of Scientific Services, and her team including their two talented lead scientists: Scott de Beer and Francisco Pera are working towards developing test kit 2.0. which will also reveal if a patient is infected by picking up the virus within patient samples. This is excellent news for Cape Bio Pharms and shows the potential of their plants – and their individual and collective knowhow and expertise. The platform they are currently perfecting could provide proteins for other diagnostics areas which are crying out for attention in Africa such as HIV and malaria.
Asked what lies beyond the COVID-19 mission, Tamlyn is excited to share the plans: a bigger laboratory, more machines and tools and a bigger team. Last but not least the long-term plan is to build a new cGMP compliant plant-based Cape Bio Pharms facility that will allow them to finally move into producing vaccines, biosimilars and therapeutics.
“We are extremely pleased with the progress made so far and I am confident that this is only the beginning. Our plant-based protein production platform is clearly demonstrating its flexibility and speed to market and that plants could be key in fighting not only COVID-19 but also other diseases,” declares a confident Tamlyn.
July 24, 2020 by ACUMEN