OUR TRACK RECORD
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
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.
Manufacturing operations in Africa to cover the demand for routine vaccines
Unizima was selected by the he 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.
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.
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