The Biovac Institute - Oct 2019 by CMB Media Group

T H E B I OVAC I N S T I T U T E

THE BIOVAC INSTITUTE

Local Vaccine Manufacture

Returns to South Africa PRODUCTION: Timothy Reeder

After years of negotiation and capacity-building, South Africa has been granted a licence to manufacture one of the worldâ&#x20AC;&#x2122;s most important vaccines, Hexaxim. South Africaâ&#x20AC;&#x2122;s Biovac Institute (Biovac) will begin production of the vaccine next year, and follow in 2020 with antipneumonia inoculation Prevnar, marking the first local manufacture since the mid-1990s: decreased cost, increased availability and a spurring of economic growth are all set to follow. 2 / www.enterprise-africa.net

INDUSTRY FOCUS: MANUFACTURING

Based in Cape Town, the Biovac Institute (Biovac) is a world-class, specialist vaccine manufacturing business based in Cape Town, which sets out to produce important vaccines for both the South African and export markets. Biovac is the result of a public-private partnership formed with the South African government in 2003, to revive the country’s human vaccine manufacturing capacity. “Our vision is to be a health-focused Centre of Excellence rooted in Africa for the development and manufacture of quality vaccines for Africa and the developing world’s needs,” the company sums up of its founding principles,

as it ensures continued and seamless delivery of over 25 million doses of critical vaccines each year to all nine provinces of South Africa, as well as some key neighbouring countries. “As the only Southern African human vaccines manufacturer,” Biovac says, “we recognise the need for a domestic manufacturer of vaccines to enable the Southern African region to respond to regional epidemics and vaccine-preventable diseases.” STEADY DEVELOPMENT When it comes to something as critical as human vaccines, the process is not one to be rushed, and consequently Biovac has had to carefully gather the

knowledge and skills to compete in the complex, challenging and strictly regulated healthcare environment. “While developing our manufacturing facilities,” Biovac explains, “we have been importing, exporting, packaging, testing and distributing vaccines. Our leap of faith ensured that we delivered the required vaccines to the children’s vaccination program, known as the Expanded Programme on Immunisation, in South Africa and the region.” The endeavour to re-equip South Africa and the African continent as a whole with a sufficiently modern manufacturing capability has, in Biovac’s own words, “progressed

MGSA PROJECTSS is proud to be part of Biovac’s success. MGSA PROJECTS looks forward to continuing to supply the equipment, service & support which has contributed to Biovac’s success. One of South Africa’s most charismatic packaging industry sale specialists, Myles Davis has launched MGSA Projects, representing some of the worlds leading players in the pharmaceutical and cosmetic packaging machinery sectors. Over the last 30 years, Myles has gained valuable experience in the packaging machinery sector, representing leading international pharmaceutical and cosmetic machinery manufacturers. He has been instrumental in establishing and coordinating numerous turnkey projects with prominent global brand owners namely Biovac, Aspen, Adcock, J & J, Bio Oil, GSK, to name a few. Our products and suppliers: MARCHESINI GROUP: Supplier to Biovac of Syringe packing line BREVETTI CEA: Supplier to Biovac of Ampoule, vial & syringe inspection equipment. Brevetti Cea is 100% focused on the design and production of inspection machines for injectable pharmaceutical products. Since the 1950’s we have been committed to supporting companies around the world in order to guarantee the use of safer medicines for patient health. Product innovation, deep know-how, continuous investments in research and development, experience and reliability, combined with a full range of Customer pre and after-sales support services highlight Brevetti C.E.A. as the ideal partner for successful investments. TELSTAR: Complete turnkey supplier & processing equipment (Autoclave, Freeze dryers, Isolators, clean air & steam water plants, clean rooms, generators and green fields to GMP, hand over facilities, turnkey project engineers. SERVOLIFT: Lifting & handling, Storage & transfer, Dosing & weighing, Blending & mixing, Granulation & coating, Cleaning & drying. KORSCH: World leaders in Tablet Man equipment EASYSNAP: Innovative & patented single use liquid packaging equipment manufacturer MG2: Leading capsule filling & handling equipment manufacturers ADAMUS: Global tablet tooling & accessories manufacturer UNITED PHARMATEK: Entry level pharmaceutical equipment supplier. For further information on our products, services & supplies please contact Myles Davis. Contacts: Sales Myles Davis +27 (0) 82 460 2766 myles@mgsaprojects.co.za Technical Lukas Appel +27 (0) 82 410 2554 lukas@mgsaprojects.co.za Office Robyn Thomas +27 (0) 66 023 4849 admin@mgsaprojects.co.za General Information info@mgsaprojects.co.za Website www.mgsaprojects.co.za

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THE BIOVAC INSTITUTE

steadily and significantly.” To date, over R600 million has been invested in infrastructure and skills development at Biovac, seeing an economic benefit of more than R500 million per year to the South African economy. “Our sustainable strength, as we progress on our journey, lies in our ability to partner with others,” Biovac makes clear. “Among others, we have partnered with research organisations like the University of Cape Town and international organisations such as the World Health Organization (WHO). We have also looked to industry as well as funding organisations like the Industrial Development Corporation and the Bill and Melinda Gates foundation.” Above all, at Biovac the primary aim is to strengthen the pharmaceutical and healthcare

environment in South Africa and Africa, contributing to the socio-economic transformation of the country and continent. “I am certainly optimistic about times to come,” summed up CEO, Morena Makhoana, when we spoke last year. “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.”

It is a vital aspect of South Africa’s expanded programme on immunisation, and more than three million children currently receive the vaccine every year. Of the 14 vaccines administered between the ages of zero and two years, four are Hexaxim. The initiative has had a marked effect on the number of children under the age of five that have died, down from 89,418 in 2005 to 47,409 children in 2013. Morena Makhoana revealed earlier this year that, in a huge move for the company and the country, Biovac will start local production of French healthcare leader Sanofi’s Hexavalent vaccine next year, with its plant set to produce four million doses of Hexaxim vaccine annually. Until now, South Africa’s government has had to buy in around 95% of the 25 million doses of vaccine supplied annually by Biovac.

HEXAXIM AND PREVNAR MANUFACTURE The hexavalent vaccine Hexaxim is used to vaccinate children against six life-threatening infectious diseases: diphtheria, tetanus, acellular pertussis - more commonly known as whooping cough - inactivated polio, Haemophilus influenza type b and hepatitis B.

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INDUSTRY FOCUS: MANUFACTURING

“We start production of (the) hexavalent in Q3 2020,” Makhoana confirmed at Biovac’s state-of-the art facility in Cape Town. Set to join Hexaxim for Biovac in 2021 is Pfizer’s anti-pneumonia Prevnar 13 vaccine, for which it expects a full output of three million doses to start in the first half of 2021. Under a five-year agreement signed with Pfizer in 2015, Biovac has to date only packaged labelled syringes but it is now acquiring the formulation and filling processes ahead of the launch. “The technology transfer process has enabled significant knowledge transfer, job creation and direct investment,” said Rhulani Nhlaniki, Pfizer’s country manager. Biovac’s dose of Hexavalent, a six-in-one vaccine for several diseases including diphtheria, tetanus and

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// THE TECHNOLOGY TRANSFER PROCESS HAS ENABLED SIGNIFICANT KNOWLEDGE TRANSFER, JOB CREATION AND DIRECT INVESTMENT // polio, is the only one in the world that is fully liquid and unlike other versions on the market, Makhoana added, does not have to be mixed before injecting. This makes it easier to administer in remote and resource-poor clinics across Africa. “On this particular six-in-one vaccine we are the only tech transfer partner with Sanofi in the world, so we are very proud,” Makhoana told Reuters, while for Sanofi, it appears clear that continued investment in South Africa’s vaccine programme will be central to bolstering its own position. “South Africa, and Africa for

that matter, is an emerging market and showing strong growth year-onyear and hence will remain a priority for Sanofi,” said Merilynn Matthew, who heads Sanofi’s South African vaccines unit. HARNESSING LOCAL PRODUCTION Local vaccine manufacture has many foreseeable benefits, including decreased cost and increased availability, as well as the capability to provide vaccines to the region. The local manufacturing process can also spur economic growth, and is a key catalyst and multiplier for job

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// IMMUNISATION IS ONE OF THE MOST SUCCESSFUL AND COST-EFFECTIVE PUBLIC HEALTH INTERVENTIONS // creation. Business Day has mooted manufacturing as South Africa’s potential ‘sunrise sector,’ and with 9.6 million of its population currently unemployed, there is a huge pool of untapped talent to dip into. Manufacturing vaccines locally firms up a sector which is prone to shortages and price fluctuations, realities which often have severe consequences for public health. Vaccines are supplied into a global

market from a relatively small number of sites and manufacturing problems, mostly linked to issues of quality and safety, occur and not infrequently affect the supply of vaccines to lower value markets. When Biovac was established the annual cost of vaccines was only R188 million, but this has since exploded to R1.75 billion. Hexaxim alone accounts for 37% of the expenditure, and being able to manufacture locally using imported antigens will enable Biovac to ensure a domestic capacity in vaccine production and save an estimated 15% of the cost compared to international procurement. “Immunisation is one of the most successful and cost-effective public health interventions,” Biovac sums up of the reverberations to be felt as a result of its commencing

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local production in the coming years, “and biotechnology will become a significant growth area and contributor to our Gross Domestic Product.” “We are building a bio-sector from scratch and that feeds into the bio-economic strategy of the country and the region,” Makhoana explained, and now Biovac is closer than ever to being able to effect the economic transformation which will result from this new era of vaccination in the country.

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