Pharmaceutical Biotechnology

African solutions for African health challenges

Pharmaceutical Biotechnology

We partner with investors, governments and entrepreneurs to set up pharmaceutical manufacturing facilities and develop products across Africa — from feasibility and GMP design through tech transfer, product development and market access. Our platform de-risks entry into one of the world's fastest-growing health markets.

The Investment Case

Why investors are moving into African pharmaceutical manufacturing

Africa imports the overwhelming majority of its vaccines and pharmaceuticals, while producing only a small fraction of what it consumes. The continent's pharmaceutical market is expanding rapidly, and the African Union has committed to manufacturing most of its vaccines locally within the coming decades — a policy commitment that is actively redirecting public procurement toward local producers.

Zimbabwe is a live example of the gap and the opportunity. The country imports the bulk of its ARVs and essential medicines, and government spending on imports is a recurring and rising cost. Local manufacturers currently have the technical capacity to produce only part of the national Essential Medicines List, despite a National Pharmaceutical Strategy that targets substantial growth in local production and local market share.

This is the gap we help investors fill.

Other reference points across the continent — Institut Pasteur de Dakar in Senegal, BioNTech's mRNA facility in Kigali, Aspen's fill-finish capacity in Gqeberha, DEK Vaccines in Ghana — show that the model works when facility development, product development and regulatory pathways are handled together. That is exactly the package this division delivers.

For Investors

What you get when you build with us

Feasibility & Business Case

Market sizing, product selection, cost-of-goods modelling, offtake and public procurement analysis for your target country or region.

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Facility Design & GMP Build

Concept and detailed design, equipment specification, cleanroom and utilities planning, qualification and validation to WHO-GMP.

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Technology Transfer & Licensing

Access to validated strains, cell lines, processes and formulations — licensed for your territory and supported through transfer.

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Product Development

Formulation, analytical method development, stability studies and MCAZ / WHO prequalification dossier preparation.

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Workforce & Systems

Training of operators, QC analysts and QA staff; QMS, SOPs and documentation built to inspection standard.

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Market Access & Partnerships

Introduction to regulators, procurement agencies, distributors and regional manufacturing networks across SADC and the AU.

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Capabilities

Everything inside this division

Grouped modules covering the full scope of work delivered by this part of the institute.

Process

  • API Development
  • Formulation Science
  • Bioprocessing
  • Quality Control
  • Regulatory Affairs

Therapeutics

  • Biologics & Vaccines
  • Phytopharmaceuticals
  • Generics
  • Antimicrobials
  • Diagnostics

Facility Development Pathway

From investment decision to product on shelf

Stage 1

Opportunity & Feasibility

Target products and market defined; demand, pricing, offtake and regulatory route assessed.

Stage 2

Site, Design & Funding

Site selection, facility concept, equipment list, capex model and investor-ready documentation.

Stage 3

Build, Equip & Qualify

Construction or retrofit, equipment installation, IQ/OQ/PQ and WHO-GMP readiness.

Stage 4

Transfer & Develop

Strain and process transfer, formulation development, analytical validation and stability.

Stage 5

Register & Supply

Dossier submission to MCAZ and regional regulators; first commercial batch released with full Certificate of Analysis.

Bioprocess

From molecule to medicine

Stage 1

Target & Sourcing

Active ingredients identified from local botanicals or synthetic routes; raw materials characterised per MCAZ guidelines.

Stage 2

Cell Line & Strain

Production organisms engineered, banked and validated for stability and yield.

Stage 3

Upstream Processing

Media and fermentation optimisation from laboratory to pilot scale under WHO-GMP conditions.

Stage 4

Downstream

Chromatography, purification and sterile fill-finish to pharmacopeial specification.

Stage 5

Product Release

Tablet, capsule or injectable released with a full Certificate of Analysis for local and export markets.

Services

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Investor Services

Pharmaceutical Facility Feasibility & Setup

End-to-end support to take a manufacturing investment from concept to GMP-qualified production.

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Pharmaceutical

Contract Manufacturing (CMO)

Tech transfer and GMP manufacturing for local and regional pharmaceutical companies — including bridge production while your own facility is being built.

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Pharmaceutical

Regulatory & MCAZ Dossier Support

Preparation and submission support for medicines registration, variations and WHO prequalification across African markets.

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Pharmaceutical

Bioequivalence & Clinical Research

Phase I–III trial support for generic and novel therapeutics, focused on HIV, TB, malaria and non-communicable diseases — the conditions driving the largest share of Africa's pharmaceutical spend.

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Laboratories

Where this work is done

ISO 17025 / WHO-GMP

Pharmaceutical Analysis Laboratory

HPLC, GC-MS, dissolution testing and stability studies for drug registration and batch release.

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ISO 15189 clinical molecular testing

Molecular Biology Laboratory

Real-time PCR, amplification and nucleic acid workflows for pharmacogenomics.

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Research

Active programmes

Active

Local Production of Antiretrovirals (ARVs)

Zimbabwe imports the bulk of its ARVs, and government spending on those imports is a recurring cost. This programme develops a licensable API synthesis and formulation package that investors can deploy as a local ARV manufacturing facility.

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Active

Zimbabwe Phytopharmaceutical Development Platform

Indigenous medicinal plants are traded widely across Harare's urban markets and form a substantial informal economy. We standardise and clinically validate these plants for priority conditions — gastrointestinal disorders, women's health and sexually transmitted infections — and package them for commercial scale-up.

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Active

Vaccine Fill-Finish and Cold-Chain Readiness

Zimbabwe has achieved strong national immunisation coverage, yet Africa produces very little of its own vaccine supply against an AU target of majority local manufacture. This programme develops fill-finish, stability testing and cold-chain capacity as a ready-made investment opportunity for Zimbabwe and SADC.

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Pipeline

Regional API Park Concept

Feasibility work on a shared API and excipient production hub serving multiple African markets, reducing duplication of capex across smaller national facilities.

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