Why Africa Needs Phages → Why Good Manufacturing Process (GMP) Matters → What to Do Next?

By emmannaemeka @ 2025-08-09T22:27 (+8)

LD;LR

Pandemics will keep coming, faster, harder, and often from unexpected places. Africa’s health systems are already stretched, AMR is rising, and we import almost all our vaccines. Phages can be turned into medicines, vaccines, and even rapid diagnostics in record time. But without GMP manufacturing, they stay stuck in the lab. Build GMP capacity, and Africa could go from waiting months for imports to making its own pandemic tools in weeks.

Why Africa Needs Phages 

When pandemic preparedness is discussed, the focus is usually on how to delay the occurrence of a pandemic, detect pandemic potential organisms, and defend against them. The world is increasingly becoming prone to more and more pandemics, which is a result of several factors. These factors include: 1. Increased urbanisation, 2. Climate Change 3. Global travels 4. Increased human-animal contacts. With the advancement of LLMs, an increasing number of skilled individuals will be able to access the information required for them to single-handedly cause new pandemics. This therefore calls for increased policy on safe technology use as well as building systems for the defence of civilisation in the event of bad actors deliberately spreading a pandemic. 

Africa faced unique challenges during the COVID-19 pandemic. These include weak health systems, limited resources, and pre-existing health burdens like HIV/AIDS and malnutrition. Additionally, the continent struggles with antimicrobial resistance (AMR), further complicating disease management. Africa faces a significant challenge in pandemic response and vaccine manufacturing, with limited local production capacity despite a high disease burden. The continent produces less than 1% of the world's vaccines, relying heavily on imports for the majority of its pharmaceutical needs. This reliance leaves Africa vulnerable during pandemics and hinders its ability to respond effectively to health crises

To prepare for the next pandemic, the Coalition for Epidemic Preparedness Innovations (CEPI) has stated a ‘moonshot’ goal: to get vaccines ready within 100 days after the next pandemic pathogen is identified. To shorten the time from pathogen identification to a vaccine, scientists have identified five aspects of support¹: 

• Leveraging existing insights on emerging pathogens

• Development technologies 

• Innovation in the vaccine-development process 

• Using advanced analytics, better data 

•  Information sharing, and continuously reviewing evidence for swift approval 

Considering the huge cost associated with vaccine and therapeutics research. The use of phages is useful and has the potential to make vaccine production cheaper. Phages are viruses that infect and kill bacteria. Several features, such as high stability, low reactivity, safety, low cost for mass production, easy genetic manipulation, and the rapid identification of target proteins, render the phage an ideal candidate for the development during a pandemic. 

They are well known as precise therapeutics for antimicrobial-resistant (AMR) infections, capable of saving lives when antibiotics fail. But their value extends far beyond that. Modern biotechnology has turned phages into versatile manufacturing tools:

Scaffolds for Vaccine Design

Phage virus-like particles (VLPs) serve as powerful scaffolds for antigen display due to their repetitive, multivalent surface structure and innate immune-stimulating properties. By genetically or chemically coupling antigens to the phage capsid, scientists can induce strong humoral and cellular immunity without the need for potent adjuvants. AdaptVac (Denmark) has developed an AP205 bacteriophage-based capsid virus-like particle (cVLP) platform using SpyTag/SpyCatcher for high-density antigen display². 

Production Platforms for Monoclonal Antibodies & Recombinant Proteins.

Phage display technology significantly advanced therapeutic antibody discovery by allowing the selection of high-affinity, human antibodies directly from large recombinant antibody libraries without animal immunization.  In this process, antibody fragments are genetically fused to bacteriophage coat proteins, allowing rapid screening of billions of variants against virtually any antigen. This approach has yielded dozens of approved biologics for autoimmune diseases, cancer, and infectious diseases Adalimumab (Humira®), discovered by Cambridge Antibody Technology using phage display, became the first fully human mAb approved for clinical use and achieved >$20 billion in annual sales before biosimilars entered the market. Other notable phage display–derived drugs include Atezolizumab (anti–PD-L1) and Belimumab (anti–BLyS).

Biopanning Tools for Rapid Diagnostic Development

Phage display enables the rapid selection of high-affinity binding proteins, including antibodies, nanobodies, and engineered scaffolds, from vast combinatorial libraries. These binders can be quickly adapted into diagnostic formats such as ELISA, lateral flow assays, or biosensors for detecting pathogens, cancer biomarkers, and toxins. The iterative biopanning process, binding, washing, and elution, yields specific and robust binders within weeks, making it a powerful tool during outbreaks. Huo et al. ³ isolated nanobodies against the SARS-CoV-2 spike protein using phage display. These nanobodies were incorporated into ELISA and lateral flow detection systems, demonstrating rapid translation from binder discovery to diagnostic assay. 

AbCellera's phage display platform rapidly identified the SARS-CoV-2-neutralizing antibody bamlanivimab in under 90 days, showcasing the technology's potential for swift responses to public health crises. This rapid development, from sample receipt to identifying potential neutralizing antibodies, highlights the platform's efficiency in pandemic situations. 

Direct Antimicrobials Against Bacterial Threats

Bacteriophages and phage-derived enzymes (e.g., endolysins) offer precision antimicrobial activity, targeting specific pathogenic bacteria while sparing beneficial microbiota. They can be engineered to carry biofilm-degrading enzymes, antimicrobial peptides, or CRISPR payloads, enabling targeted killing of multidrug-resistant (MDR) pathogens across clinical, veterinary, agricultural, and food safety contexts. Their high specificity helps limit collateral damage and slow resistance evolution compared to conventional antibiotics. LISTEX™ P100, a Listeria monocytogenes-specific phage product, is approved in the US, Canada, and EU for direct food contact to prevent contamination in ready-to-eat foods. Clinical phage therapy has gained renewed interest, with FDA approved compassionate use cases such as the intravenous administration of personalized phage cocktails to treat Acinetobacter baumannii and Pseudomonas aeruginosa infections unresponsive to antibiotics. Multiple clinical trials are now evaluating phage therapeutics for chronic wounds, cystic fibrosis, and sepsis.

In a pandemic scenario, a GMP phage facility could shift production within weeks from generating a therapy for a resistant outbreak to manufacturing a phage-based antigen for a novel viral vaccine or even producing antibodies for emergency treatment. Yet, no GMP-compliant phage manufacturing facility exists anywhere in Africa.  This is a critical blind spot in our preparedness strategy.

Why Good Manufacturing Process (GMP) Matters 

The Missing Link in Africa’s Biosecurity Infrastructure

Africa has made progress in vaccine manufacturing, with mRNA and viral vector facilities emerging in South Africa, Senegal, and Egypt, but there is no equivalent capacity for therapeutic phages or phage-based bioproducts.

The absence of GMP infrastructure means that when bacterial outbreaks occur, phage therapy must be imported from overseas research labs. That process can take weeks to months, by which time outbreaks may have spread unchecked. And in a fast-moving pandemic, the opportunity to retool phages for vaccines or diagnostics would be lost entirely.

Local GMP phage manufacturing would enable Africa to:

• Rapidly Design & Produce Vaccines : Phage VLP scaffolds like AP205 or Qβ can be engineered in weeks to display antigens from emerging pathogens.
• Deploy Immediate Antibacterial Countermeasures: Phage therapy and endolysins could treat pandemic-associated bacterial co-infections when antibiotics fail.
• Generate On-Demand Diagnostics: Phage display could deliver binders for ELISA, lateral flow, or biosensor platforms within weeks of pathogen identification.
• Protect Food & Agriculture: Phage-based biocontrol could mitigate foodborne outbreaks, preserving food security and trade during crises.

Why GMP Is Essential

Good Manufacturing Practice (GMP) is the regulatory gold standard that ensures biologics, whether vaccines, therapeutics, or diagnostics, are produced to the highest standards of safety, quality, and reproducibility. For phage-based products, GMP compliance is the difference between an experimental treatment and a deployable public health tool.

GMP standards guarantee:

• Consistency, Safety, and Quality: Every batch is manufactured under controlled conditions with validated processes, ensuring identical potency and purity across production runs for human, veterinary, and food applications.
• Regulatory Acceptance: National regulators and international bodies such as the WHO, EMA, and FDA require GMP certification for product approval, inclusion in essential medicine lists, and procurement by global health agencies.
• Scalability & Rapid Response:GMP-compliant facilities can shift from producing pilot batches for clinical trials to mass manufacturing during health emergencies, enabling fast deployment in pandemics or AMR crises.
• Trust & Adoption: Clinicians, policymakers, and the public are far more likely to adopt interventions that meet internationally recognized quality standards.

Without GMP, phage innovations remain restricted to research labs or ad hoc compassionate-use cases, unsuited for integration into national stockpiles, routine healthcare systems, or continental pandemic preparedness strategies. In practical terms, this means Africa would still rely on slow, costly imports in the middle of an outbreak rather than having the capacity to respond within its own borders.

Centre for Phage Biology and Therapeutics (CENPBAT) Role

The Centre for Phage Biology and Therapeutics (CENPBAT), established with a seed grant from Emergent Ventures and further supported by ACX Grants, is dedicated to strengthening Africa’s capacity to research, manufacture, and deploy phage-based health innovations. CENPBAT is already:

• Developing therapeutic phage banks targeting high-priority AMR pathogens in human health, aquaculture, and livestock.
• Integrating genomic surveillance to match phages with local bacterial strains
• Training African scientists in phage biology
• Partnering internationally to align with global AMR, One Health, and vaccine innovation networks for technology transfer and regulatory harmonization.

With targeted investment, CENPBAT aims to establish Africa’s first GMP phage manufacturing hub, capable not only of producing therapeutics but also phage-based vaccine scaffolds such as bacteriophage virus-like particles (VLPs). These platforms can be rapidly adapted to emerging infectious diseases and even cancer antigens, enabling:

• Rapid-response vaccine development within weeks of pathogen identification.
• Local production of thermostable, low-cost vaccines suited to African distribution environments.
• Integration into pandemic preparedness alongside phage therapeutics and diagnostics.

Such a facility would act as a multi-purpose biosecurity asset, supplying Africa with homegrown solutions for infectious diseases, antimicrobial resistance, and outbreak containment,reducing reliance on imports and accelerating the continent’s path to vaccine and therapeutic sovereignty.

What to Do Next 

If you’ve read this far, you already know the stakes: pandemics will not wait for Africa to build GMP capacity. One facility could mean the difference between importing cures months too late or producing them locally in weeks. Here’s how you can move the needle:

1. Fund Directly: Seed a feasibility study, bankroll first GMP-grade equipment, or cover initial pilot runs..
2. Connect the Dots: Introduce African research groups to phage manufacturers, process engineers, or pandemic-prep donors. Leverage your own network,your intro might be the missing link to a working facility.
3. Lend Expertise: If you’ve navigated GMP compliance, tech transfer, or regulatory approval, your knowledge could compress timelines by months or years.
4. Co-build Solutions: Partner on phage-based vaccines, AMR therapeutics, or rapid diagnostics designed for African manufacturing and distribution.
5. Shift the Narrative: Write, speak, or lobby for phage GMP infrastructure as a core pandemic-preparedness asset.Amplify this gap to philanthropists, policy-makers, and global health bodies.

Why act now?
Once the next pandemic starts, it’s too late to build capacity from scratch. The most impactful moment is before the crisis, when a single GMP phage hub could protect millions across multiple disease threats

1       Krammer, F. SARS-CoV-2 vaccines in development. Nature 586, 516-527 (2020). 

2       Brune, K. D. et al. Plug-and-Display: decoration of Virus-Like Particles via isopeptide bonds for modular immunization. Scientific reports 6, 19234 (2016). 

3       Huo, J. et al. Neutralizing nanobodies bind SARS-CoV-2 spike RBD and block interaction with ACE2. Nature structural & molecular biology 27, 846-854 (2020).