Local and Regional Manufacturing
Emerging Biopharmaceutical Manufacturers Network (EBPMN). Interested companies and organizations in Low- and Middle-Income Countries (LMICs) are encouraged to become a member of the newly established EBPMN.
UCAB facilitating role
UCAB facilitating role
Utrecht University established the Utrecht Centre for Affordable Biotherapeutics for Public Health (UCAB), as a central hub to facilitate the development of safe and affordable biotherapeutics for low- and middle-income countries in a sustainable way. Utrecht University and WHO have signed a Memorandum of Understanding in 2014 to collaborate in accelerating the availability of affordable high-quality biotherapeutics in Low- and Middle-Income Countries.
EBPMN’s Main Objectives
EBPMN’s Main Objectives
To form a voluntary public health driven alliance of biopharmaceutical manufacturers from emerging economy countries with a common vision and mission.
A voluntary public health driven alliance of biopharmaceutical manufacturers from emerging economy countries with a common vision and mission
Biovac started its journey with a big bold step that covered a lot of ground in short space of time. While developing their manufacturing facilities, they have been importing, exporting, packaging, testing and distributing vaccines. Their leap of faith ensured that they delivered the required vaccines to the children’s vaccination program, known as the Expanded Programme on Immunisation, in South Africa and the region.
To ensure continued and seamless delivery; they coordinate supply and demand with offshore suppliers, the South African Department of Health and other partners to ensure that the required vaccines get to where they are needed in all nine provinces of South Africa and a few neighbouring countries. Over 25 million doses of vaccines are delivered a year via their cold and supply chain infrastructure to ensure that the quality of the vaccines at the point of use is guaranteed.
Instituto Butantan supplies the Brazilian public health system with 90% of the antivenin and 65% of all vaccines distributed in the country. Out of the 170 million doses of vaccines dispensed annually by the Brazilian immunization program, 100 million are produced Butantan.
In particular, Instituto Butantan manufactures 100% of the influenza vaccine doses used by the Ministry of Health. Presently, they are the largest flu vaccine manufacturer in the Southern Hemisphere.
The current manufacturing capacity is the result of an internal development of processes to obtain vaccine antigens, as well as technology transfer processes and Productive Development Partnerships between Butantan and external Laboratories.
China National Biotec Group Company Limited (CNBG), formerly the Central Epidemic Prevention Department of Beiyang Government, was directly under the leadership of the Ministry of Health after the founding of New China. It is now an important member company under one of the global top 500 companies --- SINOPHARM. CNBG has been recognized by the Chinese industry as a comprehensive biopharmaceutical enterprise with a long history, complete product portfolio and large manufacture capacity. The company has integrated functions of R&D, production, sales and postgraduate training. CNBG currently has 11 secondary subsidiaries and 69 sub-secondary companies with over 10,000 employees.
CNBG has six major business segments: human vaccines, blood products, medical aesthetics, animal healthcare, biotherapeutics and medical diagnostics. CNBG can produce 50 kinds of human vaccines with an annual output of over 700 million doses. It supplies over 80% vaccines for the National Immunization Program. CNBG holds a public listed company dedicated to blood products production, with annual plasma collection of more than 1500 tons, the company is capable to produce 11 kinds of blood products. As the only botulinum toxin manufacturer approved by the government in China, CNBG’s own branded products are highly recognized by the medical aesthetics market. CNBG is also providing the society with all-round and high-quality services for animal vaccines and related veterinary biological products. The company is currently developing a complete industrial chain for antibody drugs and a unique industrial chain for molecular diagnostic products.
CNBG has strong scientific and technological innovation strength, with a research and development team of more than 1,000 people and a quality management team of more than 1,100 people, including an academician of the Chinese Academy of Engineering, a chief scientist of the national "863" vaccine program, and 13 members of the National Pharmacopoeia Committee. The company has 5 postdoctoral workstations, 1 doctor’s degree awarding point and 5 master’s degree awarding points, which have cultivated many advanced talents for China’s biopharmaceutical industry.
Panacea Biotec is one of India’s leading research-based health management companies with established research, manufacturing and marketing capabilities. Panacea Biotec is the 2nd largest vaccine manufacturer in India. Panacea Biotec has been ranked as the 3rd largest biotechnology company (ABLE Survey 2006) in India and is also amongst the top 50 pharmaceutical companies in India.
Panacea Biotec has registered turnover of Rs. 5480 million during FY2006. The product portfolio of the company includes highly innovative prescription products in important therapeutic areas such as pain management, diabetes management, cardiovascular management, renal-disease management, osteoporosis management, anti-tubercular, gastro-intestinal care products and vaccines. The company has collaborations and tie-ups with leading national and international research organizations and corporations. The company’s state of the art manufacturing facilities comply with the US-FDA, UK-MHRA, SA-MCC and WHO-CGMP standards. The company has four ultra modern, states - of - the - art research and development centers. The company also has 10 international product patents. The company has over 2,300 employees including over 200 highly skilled scientists.
Panacea Biotec has developed several innovative vaccines.
TechInvention Lifecare Pvt Ltd is a company headquartered in India, focussed on Innovation in Vaccines & Biologics. It also supports manufacturing capacity-building initiatives for Vaccines & Biologics in LMIC’s. Towards this TechInvention has a 2 vertical concept:
a. The first focussed on Research and Development of Novel Vaccines and Biologics with the focus being Recombinant Technology-based products further categorized into Human Vaccines, Monoclonal Antibodies for infectious diseases. A new initiative of development of Lysins to manage ESKAPE pathogens and MTB is also on the anvil. The Technologies so developed are keeping requirements of LMICs in mind which result in products that are Compliant, Efficacious, Safe, and Cost-Effective. TechInvention has delivered many a successful technology transfer to Developing Country Manufacturers across continents and the portfolio is getting strengthened year on year.
b.The second vertical is focused on: Technical and Strategic advisory for local manufacturing of Vaccines and Biologics in LMIC’s. The scope for these projects being encompassing from: Feasibility study, Design, Project management, Tech transfer partnerships, QMS training, and institutionalization. The project outcome being: state of art facilities that are compliant and producing quality products that are cost-effective thereby rendering the initiative viable and sustainable. Further, this model has enabled Developing country manufacturers to secure long-term supply contracts in LMICs. Successful Project outcomes have been observed in TechInvention engaged projects even in case of projects planned in Low-Income Countries with pragmatic strategies, adept conceptualization, and flawless execution.
Vabiotech - is a state-owned enterprise under the Ministry of Health - Vietnam established in 2000. It is one of the leading companies in the field of research, production and sales of vaccines and biologicals for humans in Vietnam with production facilities meeting WHO-GMP, GSP and GDP standards; ISO 9001 - 2008 quality management system;
Currently, VABIOTECH manufactures and sells four main products: Hepatitis A vaccine, Hepatitis B vaccine, Japanese encephalitis vaccine and the oral vaccine. Vaccines produced by VABIOTECH are used in the National-Vietnam Expanded Immunization Program, the domestic market and export.
“Enhance access to biopharmaceuticals by facilitating local manufacturing capacity in Low- and Middle Income Countries ”