OUR TRACK RECORD
AFRICA
Africa
Senegal:
Madiba and Measles-Rubella Project
Working with Institut Pasteur de Dakar, Unizima is providing recruitment, workforce development and operational support for the Manufacturing in Africa for Disease Immunisation and Building Autonomy (MADIBA) project, a first-of-its kind, modular African CDMO for vaccines. Funded by a coalition of international donors and governments, MADIBA will leverage Unizima’s expertise and Univercells’ equipment, to reach a capacity of 300 million doses/year for a range of epidemic and
routine diseases.
Unizima’s embedded team on the ground helped set up the early phases of the project and continues to provide key support to leadership on recruitment, planning and procurement to increase technical capabilities and operational readiness on site.
In parallel, supported by a grant from the Bill and Melinda Gates Foundation, Unizima is enabling the tech transfer and production of a new measles-rubella vaccine – the first to be developed in Africa - at the MADIBA site, working with partners such as Univercells Technologies and Batavia Biosciences. Measles-Rubella is one of the vaccines that Gavi has indicated would benefit from additional global suppliers and this initiative aligns with the Partnership for African Vaccines Manufacturing goal of 60% of routine vaccines being produced locally in Africa by 2040.
Africa
Manufacturing operations in Africa to cover the demand for routine vaccines
Unizima was selected by the Deutsche Gesellschaft für Internationale Zusammenarbeit (GIZ) GmbH to conduct a business case simulation for fill & finish contract manufacturing operations in Africa to cover the demand for routine and novel vaccines. The study involves:
a) Analysis of capital and operating expenses for running a Fill & Finish CMO for both glass and BFS vials
b) Costing simulation tool to assess the financial viability of setting up local F&F operations and comparing local production to import
c) Recommendations and strategic advice for establishing sustainable CMO plants across Africa
The study will conclude in March 2023.
Africa
Algeria:
Expansion of our client’s biologics portfolio
An Algerian pharma company producing generic drugs, biosimilars and food supplements required support to expand their biopharmaceutical product portfolio.
Unizima identified a shortlist of biosimilar target products that represented an attractive business opportunity and subsequently engaged with product licensors to evaluate potential collaboration possibilities and identify mutually beneficial models. Unizima secured three non-binding term sheets for our client.
Unizima continues to support ongoing discussions with the licensing partners, serving as an expert consultant for the local client to plan and help execute the next steps needed to support the integration of the new biologics into their existing operations.
Africa
Mozambique:
Feasibility study for a new vaccines Fill & Finish facility
A pharmaceutical company in Mozambique identified a market opportunity to diversify into vaccines and develop Fill and Finish (F/F) capacity for vaccines listed on the National Immunization Calendar, in anticipation of Mozambique graduating from GAVI in the coming years. To secure investment from local and international funders for this project, the client commissioned Unizima to conduct a feasibility study for a local F/F facility.
Unizima provided the client with expert analysis based on their needs:
a) Insights on the local pharmaceutical industry and local as well as global market dynamics for their vaccine products of interest
b) Competitive landscaping exercise including the advantages and drawbacks of operating under an in licensing model vs a CMO model
c) Regulatory requirements including WHO PQ
d) New F/F factory lay-outs and Capex estimations, F/F factory workforce and Opex estimates
e) NPV analysis including sensitivity analysis
f) Project risks including detailed mitigation plans
Africa
Egypt:
Unizima is working with an established pharma company in Egypt
KelixBio is an established pharma company that is willing to empower Fill & Finish capability in its portfolio. They have several facilities worldwide and asked Unizima to diagnose their company to propose a solution country to host a potential modular facility.
Unizima delivered the diagnostic of several facilities and Egypt has been inspected and targeted as the country that could receive the potential installation of a modular facility.
A gap analysis and design review followed and Unizima’s expert targeted the following products: biosimilars and insulins.
Africa
Zambia:
Feasibility study on the creation of a new pharma manufacturing hub
A pharmaceutical company based in Zambia is expanding its product line to produce EPI vaccines in alignment with the government's vision of establishing a self-reliant hub for vaccine fill and finish.
The company is actively collaborating with the Zambian Ministry of Health to combat the Cholera outbreak by supplying finished-packed Cholera vaccines. In addition to providing conventional support, they will organise the vaccine tech transfer for local fill and finish operations.
Unizima has been commissioned to conduct a feasibility study on the market opportunities for the fill-and-finish hub:
- Market opportunities on vaccines, biosimilars, insulins
- Definition of the HR resources needed
- Estimation of CapEx investment
- Estimation of the operation cost
- Estimation of the project profitability and risks
and to conduct market research on licensors of the cholera vaccines:
- Sourcing of cholera vaccine suppliers
- Introduction to the recommended supplier
- Negotiation of a supply agreement and future tech transfer of the vaccine.
Unizima is the bridge establishing mutually beneficial partnerships. This collaboration will enhance local biotechnology capabilities and position Zambia as a key player in vaccine production.
Africa
Senegal:
University partnership with University Amadou Mahtar
To strengthen vaccine production capacities in Africa and build resilience, we need an integrated ecosystem approach in all vaccines manufacturing supply chain steps starting with R&D and talent development.
Unizima's offer on workforce development starts with academic partnerships, leading the collaboration with University Amadou Mahtar (UAM), Université Libre de Bruxelles (ULB) and Univercells. The 3 entities joined forces to provide hands-on training to the UAM students.
Two successful cohorts completed a 3-month program with an innovative internship at Quantoom Biosciences and gained academic knowledge supervised by ULB on bioinformatics, quality assurance, regulatory compliance, and process methodologies.
Students and teachers receive a holistic education and real-world exposure, bridging the gap between academia and industry. The initiative positions these individuals as well-equipped contributors to the biotechnology sector, enhancing their employability and catalysing advancements toward Africa’s autonomy in bioproduction.
Africa
Benin:
Feasibility study for a new biologics Fill & Finish facility
Our client is a private company based in Benin that focuses on public health and collaborations with the biotechnology and pharmaceutical industry. The company's current project involves investing in a manufacturing facility for producing IV solutions for the local market aligning with the Benin government's support for the development of the pharma and biotechnology sector. The overarching goal is to foster manufacturing autonomy and enhance Benin's technological and industrial capacity.
For this project, Unizima gave the client their biomanufacturing's expertise and delivered:
- Review of the Investment Business Case
- Introduction to investors such as the African Development Bank
- Extension of the business case to future biologics such as mAbs and insulins
- Engineering advice
- Process equipment advice
This collaboration is working towards achieving bioproduction autonomy in Benin and Africa.
MIDDLE EAST
Middle East
Saudi Arabia:
Investment/Upgrade studies and GMP compliance audit for a fill & finish facility for insulins
Our client, a prominent corporate entity from Saudi Arabia, has successfully acquired a Fill & Finish factory, which is a facility that specialises in packaging insulin for the local market. Our client's strategic vision includes upgrading the existing insulin filling line, establishing quality control laboratories, adding a second high-capacity filling line, and implementing an assembly line dedicated to insulin pen production. These initiatives have been designed meticulously to align with the rigorous compliance standards set forth in the European Union's cGMP guidelines and Annex 1.
Furthermore, the customer is committed to enhancing its Quality Management Systems (QMS) in strict adherence to EU cGMP guidelines. They will execute these critical re-engineering projects with unwavering dedication, supported by expert project management and meticulous procurement strategies.
Unizima is providing invaluable expertise to the client in this endeavour. Our services include a detailed re-engineering study of the existing insulin filling line, comprehensive engineering studies for the setup of cutting-edge quality control laboratories and new production lines, a thorough GMP compliance audit adhering to EU cGMP guidelines and Annex 1, complete with actionable recommendations for QMS enhancement, and proficient project and procurement management to ensure a successful transformation.