T H E B I OVAC I N S T I T U T E
THE BIOVAC INSTITUTE
Biovac to Produce
GBS Vaccine
in Cape Town PRODUCTION: David Napier
South Africa’s Biovac Institute is developing a novel vaccine against Group B Streptococcus disease. Supported by PATH, developing the vaccine in South Africa is proof for CEO, Dr Morena Makhoana, that this local industry leading organisation is working to international standards. www.enterprise-africa.net / 3
INDUSTRY FOCUS: MANUFACTURING
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The Biovac Institute is a world-class, specialist vaccine manufacturing business based in Cape Town. The company was set up to produce important vaccines for South Africa, and for export markets. Like another of Cape Town’s key industries, wine, human vaccines need patience to make as they take a long time to research, trial, produce and distribute under cold chain conditions. Just as you would with vines, you must first establish the optimum conditions and facilities for producing a quality product and have in depth knowledge about the market to which you will supply. Since its official formation as the organisation we see today, Biovac has developed the knowledge and skills to play in the complex, challenging and strictly regulated healthcare
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environment. CEO, Morena Makhoana – a medical doctor by training – says that the future of the business is bright, and export opportunities and new partnerships are giving this internationally respected organisation much to be excited about. “I am certainly optimistic about times to come,” he tells Enterprise Africa. “Because vaccines are part of a country’s primary healthcare system, regardless of the cycles in the economy, there is always a need to vaccinate children against diseases.” Recent successes have seen Biovac add new products to its portfolio and, through international cooperation, realise the ambition of manufacturing new vaccines locally. “We now have strategic partnership agreements with three leading global
organisations that we are very proud of,” says Makhoana. GBS The most recent project that Biovac has been involved with is an internationally significant vaccine development programme, in partnership with Seattle based PATH, which will see the company become one of the world’s first organisations to develop a product that can vaccinate against Group B Streptococcus (GBS). A leading cause of infection in new-born babies, GBS currently has no licensed vaccine and in parts of the developing world, mortalities have been prominent. “It’s a very exciting vaccine and it’s not ‘just another product’ that we are developing,” says Makhoana.
INDUSTRY FOCUS: MANUFACTURING
// THERE ISN’T A QUESTION ABOUT IF A PANDEMIC WILL STRIKE, THE QUESTION IS WHEN – FLU STRAINS CHANGE // “While two other multinational companies are also in the process of developing this vaccine, Biovac is currently the only company, that will be developing and manufacturing the vaccine in the developing world That is a unique opportunity to showcase our capability, it will answer the call
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to vaccinate against a disease that is specific to Africa and prevalent in other parts of the world, and it will build our intellectual property and capability to potentially supply globally.” If Biovac’s plans are realised, this could be the start of an exciting journey for the company, further embedding its reputation as a globally recognised establishment. “This we hope will be a global product that can allow us to enter the global vaccine supply eco-system,” details Makhoana. “Our ambition is for us to be a global supplier in time, much like our counterparts in India.” It is previous successes and a proven track record that has led Biovac to this point. Several successful milestone moments in the company’s
history have confirmed it is able to deliver to partner internationally. “The past six years have been where the momentum has come through,” admits Makhoana. He explains that the company reviewed its strategy and moved to an approach of backward integration of its product offering where Biovac initially focussed mainly on importing, packing and labelling vaccines, while building their vaccine manufacturing facilities. In 2012, Biovac signed its first major transaction with a global pharmaceutical company - the French giant, Sanofi. “The second big milestone came in 2015 when we signed a deal with America’s Pfizer for one of their flagship
THE BIOVAC INSTITUTE
products,” explains Makhoana. “With Sanofi, we will be filling the already blended products in a sterile process. The Pfizer arrangement will see us blending the product locally and while it sounds simple, it is actually a very complicated technical arrangement that increased our capabilities to deal with biological products. Our recent agreement with PATH with the support of is a product development project and it completes the value chain. We remain an importer, but we are now getting involved with manufacturing, and we also contributing to R&D in an environment where we don’t have a large skills base and where we don’t have many vaccine manufacturers.” Of course, our investment in job creation and the development of internationally acclaimed sterile manufacturing skills is part of our contribution to our economy. Other than these important projects underway, Biovac is looking for more opportunities where its expertise could be deployed. “We are here to stay, and we certainly have more projects to come,” says Makhoana. He uses Ebola and flu as key examples of how the African continent battles to respond to severe pandemics, and while Biovac will not look to develop an Ebola vaccine, flu could
certainly represent an opportunity for local manufacture. “Influenza is something which has been present for many decades, there isn’t a question about if a pandemic will
strike, the question is when – because flu strains change and evolve,” he says. “There was the 1918 pandemic, the 1968 pandemic, the 1978 pandemic, and the 2009 near-pandemic. With all of these pandemics, governments tend to become nationalistic and tend to drive their resources inwardly, therefore looking after their own first. There are many flu vaccine manufacturers globally for seasonal use but when a pandemic strikes these companies would struggle to serve all the global demands and their priority will typically be to serve their immediate geography first, leaving those that do not have vaccine manufacturing capability at the back of the vaccine procurement queue. The 2009 flu pandemic threat was a stark reality check for the WHO and the South African government to such procurement risk. This is why Biovac is looking to collaborate with a likeminded company keen to share their
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INDUSTRY FOCUS: MANUFACTURING
// WE HAVE 300 PEOPLE AND 65% HAVE UNDERGRADUATE DEGREES – THAT TELLS YOU ABOUT THE CALIBRE OF PEOPLE WE HAVE, BUT IT ALSO TELLS YOU HOW EXPENSIVE THEY ARE // vaccine manufacturing technology so that we could produce their flu vaccine here in South Africa on a routine basis. Doing it routinely is very important as when it becomes routine, it’s much easier to upscale when the need arises. It’s not just about commercial success but also about responding to South Africa’s needs.” He cites Australia’s CSL (now Seqirus) as the perfect example of a business that has excelled with flu vaccine production, ramping up operations to export globally. SOUTH AFRICAN STORY 2003 was the year which saw Biovac being launched as a public-private partnership, but its story goes back further than that. The company has always been involved in the health industry, but it has been set up in different formats before realising the success it now enjoys. “In the mid-60s, most governments in the developed or developing world had vaccine manufacturing assets which were state owned. South Africa was one of those which had its own vaccine manufacturing capabilities,” recalls Makhoana. “The country was in isolation because of apartheid so there was a need for self-sufficiency. Fast-forward and South Africa became more isolated; the economy in the 80s was not doing well and the then government was not investing in vaccine manufacturing assets. On the other hand, globally, technology was advancing and new and more advanced products were coming into the market.” The country was importing more and more vaccines than before, and manufacturing was largely neglected. But, like all industries, 1994 gave local
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vaccine production a shot in the arm. “1994 and the new dawn came, a new government took over and between 94 and 99, they reviewed all state assets and the vaccine asset came to the fore. At that time, the state vaccine asset was not producing much. Two facilities had been shut down already and there was only one facility remaining in Cape Town. The government consulted globally and came to the decision that a publicprivate partnership was needed where the State does not run the asset but has
equity because of its strategic nature. “There was a competitive bid and that culminated in the Biovac that we know today where private and public shareholders are both well represented and operate is a symbiotic arrangement,” says Makhoana. Initially, Biovac was led by Selwyn Kahanovitz, a pharmacist with a business importing vaccines. When the opportunity came to bid, he put together a consortium that was successful and he became the first CEO of Biovac from 2003 to 2010. Makhoana joined in 2004 as Medical Affairs Manager, becoming deputy CEO in 2008 and taking over as CEO in 2010. “Prior to joining Biovac, I was in clinical medicine in the public health sector where I was a practicing doctor. Coming into Biovac was my first entry into the commercial world. I wanted
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THE BIOVAC INSTITUTE
to get into industry using my medical knowledge but I did not have the vision of becoming CEO,” admits Makhoana. AFRICAN SOLUTIONS PROVIDER Biovac wants to become ‘a key pillar to Africa’s growth’. “The vision is about building capacity in a sustainable way,” says Makhoana. One of the company’s key objectives is to strengthen the pharmaceutical and healthcare environment in South Africa and Africa. Makhoana is ambitious and enthusiastic about the prospects of growth on the continent and says that the growing wealth of the continent should help drive expansion of the industry. “We are already active in the countries around South Africa including Namibia, Swaziland, Mozambique and Botswana,” he says. “Further north is where the challenge comes in. The
continent is becoming wealthier, but we have not seen countries start to purchase vaccines themselves– vaccines have typically been donated by UNICEF, GAVI, WHO and other international organisations. Mostly, the vaccines are donated to countries that are low income and this means the direct markets in those countries are very small. “Governments are the largest buyers of vaccines, so we take various approaches. Where there is selfpurchasing, we try and access those markets as much as we can – that’s middle-income countries surrounding South Africa. More than 65% of vaccines come to the continent through the donor mechanism. The other method is to develop our own vaccines that can be supplied directly to the WHO so that we don’t have to be reliant on a single partner. We would also target the smaller
private markets in countries like Nigeria.” Exporting will help to ensure Biovac’s capacity is effectively and efficiently utilised. “Vaccines is a volume game. We cannot rely on South Africa alone,” says Makhoana. Fortunately, Africa is home to some of the world’s fastest growing economies and countries such as Ethiopia, Kenya, Uganda and Tanzania are expected to achieve significant GDP growth figures of between 5.2% and 8.5% through 2018. Ongoing reforms and the improvement in commodity prices has driven up export revenues across the region and this is good news for South Africa’s exporters who are looking to Africa as an opportunity. At home in South Africa, the economic picture remains unclear. While confidence and sentiment have improved since political stabilisation in
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INDUSTRY FOCUS: MANUFACTURING
// A FEW YEARS AGO, PEOPLE ASKED ME ABOUT MY BIGGEST HEADACHE AND I ALWAYS SAID IT WAS FUNDING. NOW, SKILLS IS MY NUMBER ONE PROBLEM // January, meaningful and sustainable growth figures are yet to be realised, but Makhoana remains confident. “If the economy continues at its current rate for the next five years, or if it deteriorates further, new vaccines are unlikely to be introduced and that could make our business stagnant from a growth perspective. In the short term, we have not felt an impact, but we are monitoring to ensure we are prepared for the future,” he says. “I’m an eternal optimist,” he adds. “Personally, I feel the current administration is stabilising the country. Like with any injured patient, the first thing you do is to stop the bleed and I think that is what is happening right now. After next year’s election, should they continue on this trajectory, that’s where they can start building the economy and in the next five years we should see real growth.” BUILDING AN INDUSTRY Vaccine manufacturing forms part of the wider pharmaceutical industry, which forms part of the wider healthcare industry. Vaccine manufacture is more of a biological speciality than a chemical concern (traditional pharmaceuticals) and, as such, it comes with more complex issues making it a more difficult market to enter. This is why Biovac must invest heavily in its people to ensure it has the top talent available and ensuring that the industry is prepared for the future. “We are forging links with the local
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universities where we can outsource work or access their skills much like the sort of eco-system you have in other parts of the world,” says Makhoana. “A few years ago, people asked me about my biggest headache and I always said it was funding. Whilst funding remains a concern, retention of our employees and their skills is my number one problem. We often thought that we were unique in that respect however it appears that it is a global phenomenon in our industry. “We are building a bio-sector from scratch and that feeds into the bioeconomic strategy of the country and the region. “In South Africa, we are not short of high-calibre academic skills – we have many PhD and Masters educated people. The conversion of those skills into day-to-day manufacturing is where we find the challenge. Fortunately, our staff turnover remains relatively low
and our ongoing investment in growing our people’s capabilities and enabling their career growth within our growing business is paying off. We have 300 people and 65% have undergraduate degrees indicating that our staff calibre is high. Our skillset is world renowned, scarce locally and therefore expensive. “Investing in continuous learning and development is costly. Biovac often look to other parts of the world to bring expertise to our people due to a lot of the applicable training courses and networking conferences being conducted overseas. Our ongoing skills development investment is much larger than that of a typical pharmaceutical company. We pride ourselves in investing in our people ultimately also to ensure we offer effective products and services to our customers, whether directly through the healthcare service providers or whether indirectly to the end user, the consumer. We typically
// Intramech and Biovac The “FOCS R” chillers used for The Biovac Institute are configured in a typical primary/secondary loop chilled water system. The plant consists of three 600kW super low noise air cooled heat recovery screw chillers to provide the required cooling and heating capacities . The chillers include special sound attenuation features to ensure that noise levels are kept to a minimum to accommodate the residential area located nearby as this is a 24 hour operation facility. The plant deploys a minimum cooling base load to ensure that hot water production is always available. The purpose of this plant is to produce the required climate conditions within the vaccine rooms that are maintained through cooling and reheating of the air provided to the rooms. This is to ensure that the quality of the product is maintained and that the integrity of the institute is upheld. The Biovac Institute is a vaccine manufacturer based in South Africa with a vision to contribute to the health needs of Africa and developing countries
INDUSTRY FOCUS: MEDICAL
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THE BIOVAC INSTITUTE
get the raw skills from the universities or other pharmaceutical companies, but we have to convert those skills into biological vaccine skills. This is done in places like Europe with established international companies like our partners. In return those acquiring the skills first hand then share their new skills with the rest of the team back home,” the CEO says. Asked if Biovac is the local industry leader, Makhoana is in no doubt. “From a local vaccine manufacturing perspective, right now Biovac is the only local manufacturer,” he says, “but that does not stop anyone coming in - it’s not easy, but it could happen.” The company’s competition for market share comes from international players looking to get involved or strengthen their position in Africa. Big global names sell into Africa and deliver products that are well-known and extensively used in other markets. “Our strategy is to manufacture locally, provided that the current preference is to buy locally manufacture products. It doesn’t happen at all costs but it has to be balanced between locally manufactured and imported products. We are in a favourable position as we are the only local manufacturer but if an important product comes in at such a discounted rate and we cannot match that, we understand normal market dynamics and we could possibly lose out.” The company is gearing up to face increased competition by building its export capabilities and building relationships in new markets so that exporting can become a bigger part of
// LIKE WITH ANY INJURED PATIENT, THE FIRST THING YOU DO IS STOP THE BLEED AND I THINK THAT IS WHAT IS HAPPENING RIGHT NOW //
Biovac’s success. “Exports have to be the main market in time,” insists Makhoana. “South Africa will always be our primary market but we have to look at exporting to make sure we are sustainable. Other local pharmaceutical companies have done that successfully, look at Aspen Pharmacare.” Just like South Africa’s top vineyards putting the country’s wine industry on the map, Biovac hopes to be the business that showcases South African vaccine manufacturing to the world. “Like any CEO building a company they passionately believe in, Biovac is close to my heart,” says Makhoana. “International competition, skills acquisition and retention and funding remain positive challenges, but as long
as we follow our strategy and the longer we continue achieving our small and big goals, we will gain the attention of and remain top of mind for our current and future international partners. This ultimately validates that we at Biovac are doing world-class things in the right way, with quality standards intact. “My vision for Biovac in 2030 is to be in many geographies offering vaccines and other biological products to the world. I am confident that we will get there and I am proud,” he concludes. .
WWW.BIOVAC.CO.ZA
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