Manufacturing Vaccines
GennVax Vaccine
Facility
Manufacturing Vaccines
GennVax Vaccine
Facility
State-of-the-art
GennVax Facility
GennVax, which will be established by Gennecs team, will include global experts in vaccines and top-notch leaders from all across the globe with the right exclusive tech transfer providers assuring all production lines to be WHO PQ & European GMP accredited and in parallel with proper R&D technologies.
- The biggest full production cycle vaccines facility in the region catering to Africa and the MEA region.
- Full vaccines portfolio for current NPIs needs and for future modernization across the region.
- Applying the highest vaccine manufacturing technologies with a robust data infrastructure.
International Standards
Compliance Criteria
Establishing GennVax to be the biggest, fully WHO PQ & GMP accredited facility in the region.
The separate and fully equipped R&D entity, Animal House and Starin Bank fully dedicated to the region for any emerged epidemics.
The R&D pillar in GennVax will act as a base of vaccine innovative products and new molecules/strains production within vaccines manufacturing era.
Why Egypt?
Egypt In Maturity Level 3
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WHO announced Egyptian Drug Authority reaching Maturity Level 3 (locally produced & imported) which will allow GennVax to get WHO PQ for all its vaccines/production lines.
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WHO is fully aligned with the vaccines local manufacturing roadmap and demand.
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Egypt has the most advanced pharmaceutical industry infrastructure within the region.
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Egypt is considered the biggest birth cohort with the largest population in the GAVI allies. It is considered to be the biggest direct-procurement country in the region.
Why Africa
Is the Continent of Interest?
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GennVax will act as a hub to secure all African demand from vaccines.
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WHO roadmap for Africa; to reach that 60% of required vaccines to be manufactured locally by the year 2040.
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GennVax mission is to enhance this access to vaccination for all African countries.
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Lowest coverage rate specially for essential vaccines in NPIs due to barriers concerning access to vaccination.
GENNVAX
Land in Suez Canal zone 49,048 m2
The Project Is Entitled To Several Competitive Edges
Project’s Summary
A team of top global vaccine experts will ensure that all GennVax production lines – which produce 14 different vaccines – that are WHO PQ (prequalified) & GMP- accredited with the right choice of technology transfer
Phase 1
Ready to Fill Production (RTF)
Phase 2
Full Production Cycle (FPC)
GennVax Key Strengths & Risk
Tech Transfer Secured for 18 Vaccines & Sera products
Agreement Reached and Signed to procure other manufacturers for technology rights for a total of 18 vaccines
Local Price Differential Advantage
GennVax is entitled to a 15% price differential compared to multinational vaccine manufacturers according to the Egyptian Ministry of Heath
Renowned EPC Contractor
Italian contractor, CSV, has a rich track record in the pharmaceutical field and has been signed as GennVax’s EPC contactor
Strategic Land
The facility will be constructed in the Suez Canal Industrial Zone, over an area of 49,048 sqm in agreement with SC zone.
Expert Management Team
An experienced team with extensive knowledge in the field have been exclusively selected to manage establishing the vaccine manufacturing facility.
State of art Facility
The detailed designed facility, houses a contemporary R&D and animal house, along with BSL (Bio Safety Level) 2/3 labs & cabinets
R&D Hub
The first R&D Hub in Egypt- Africa to support local research for all vaccines needed in the continent
Strain Bank
The First Strain Bank in Egypt-Africa to facilitate studies of any confined pandemics in the continent
Value Proposition
Strategic Advantage
The biggest facility in Africa that covers: R&D pillar which is crucial for the region to be self-sufficient full cycle vaccines manufacturing BSL (Bio Safety Level) 2/3 labs & cabinets following the WHO PQ standards.
Unique Hybrid Model
Vaccine Manufacturing
Manufacturing Scope
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mRNA
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Recombinant vaccines
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Conjugated vaccines
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Inactivated
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Polysaccharides vaccines
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Local development & manufacturing of Covid-19 vaccine
GennVax Facility
Capacity
GennVax facility is a state-of-the-art vaccine facility with unique advanced manufacturing equipment, resources, & technologies to fulfill the supply of key vaccines across the region covering all local and regional national EPI programs with the highest production capacity that will act as a hub in Africa catering to the MEA region.
280
Million
Doses/Year
Platform Technologies
Tech Transfer
Successful and strategic world-class partnerships to establish GennVax facility.
Partnerships with more than 25 global tech transfer providers for a wide range of key vaccines to fulfill all local and regional needs for NPIs vaccines and future addition of NPIs modernization.
Vaccines
SERA Products
Immunoglobulins
Generics
Gennecs Portfolio
Gennecs group is acting as a local / regional representative and the partner of choice for more than 10 top global pharmaceutical manufacturers and distributors, forming the biggest portfolio within the region. Our portfolio includes many of the top vaccine manufacturers like “Moderna”.
Gennvax Quality Management System
Full Alignment with WHO- PQ & EMA Guidelines
The Gennvax Quality Management System (QMS) has been designed to define and manage all activities in the Gennvax organization that could impact product quality or compliance with regulatory requirements and compliance with relevant industry standards
Regulatory Bodies
Industry Standards
The QMS is organized as a series of policies that define how the company will manage its business and a series of procedures organized into specific area of company activities called Quality System Elements.
Quality Policy
Senior Management responsibilities for Quality
Cyber security
Training
Quality Manual
The QMS structure
Data security
Governance and Oversight (for Quality and Regulatory Compliance)
Ethics
The Compliance Council
Containment
Containment
Cross contamination control
Other policies will be established as the project moves forward. These will include policies on operational and quality activities and those of support functions such as Marketing, Legal and Finance.
SDG Alignment
GennVax Corporate Social Responsibility
Initiatives Across Africa
Gennvax is a member in the
African Vaccines Manufacturing Initiative
To promote the establishment of sustainable human vaccine manufacturing capacity in Africa
Climate Change Strategy 2050
GennVax is addressing the impacts of climate change, in alignment with Carbon Neutral Environment of COP27 through:
Leading Green Vaccine Facility in the world with solar panels
Enhancing research, technology & knowledge transfer
Enhancing Adaptive Capacity & Resilience to Climate Change
GennVax Academy
Gennvax has established the Gennvax Academy to provide training and education to individuals who are interested in pursuing a career in the vaccines manufacturing industry. This academy aims to develop and enhance the skills and knowledge needed to succeed in this industry by providing both theoretical and practical training.
The Gennvax Academy’s curriculum covers a range of topics related to vaccines manufacturing, including vaccine development, vaccine formulation, quality control, and Good Manufacturing Practices (GMPs). In addition to theoretical training, the Gennvax Academy also provides hands-on training using state-of-the-art technologies and facilities at the Gennvax production facility.
The Gennvax Academy’s added value lies in its ability to develop a pipeline of highly-skilled and capable professionals who are well-versed in vaccines manufacturing and quality control. The academy provides an opportunity for individuals to gain the necessary knowledge and hands-on experience to succeed in the pharmaceutical industry in general, and vaccines manufacturing in particular.
By investing in this educational academy, Gennvax is not only preparing the next generation of vaccines manufacturing professionals, but it is also contributing to the development of the local workforce. This will ultimately help to strengthen the local economy and contribute to the growth of the pharmaceutical and biotechnology sectors in Egypt and Africa as a whole.
Overall, the Gennvax Academy is an essential component of our commitment to vaccines manufacturing and our efforts to improve public health outcomes in Africa and beyond.
Job Background Training
Technical Training provided In-house and external from different expertise.
Professional Experience
In house and external (seminars, conferences, industrial organization training, PDA, ISPE, etc.)
On Job Training
Working with international vaccine & sterile product manufacturers
R&D
Monitored by policies & procedures to assure learning outcomes
Egyptian prime minister cabinet
grants the golden license to "Gennvax Egypt"
Egyptian prime minister cabinet
grants the golden license to "Gennvax Egypt"
