The World Phage Week (October 22-28) 2025 is here, celebrating the birthday of Frederick Twort, a pioneer in phage research. This year, to mark this event, The Phage and Phage Hunters Training and Research Program (PHTRP) has brought together a special webinar series starting 22, 23 & 24 October 2025, exploring the latest research in phage science, from regulatory reforms and commercialization to production scale-up.
About Dr. Mayukh Das
The second day of the World Phage Week 2025 continued with a thought-provoking session on “Phage Therapy Commercialization and Market Pathways” by Dr. Mayukh Das, the speaker, who is the Chief Operations Officer(COO) at PHIOGEN, a Texas-based biotech company developing next-generation phage therapeutics to combat antimicrobial resistance (AMR). Dr. Das is involved with strategic product commercialization and oversees PHIOGEN’s operational strategies and supports clinical development efforts. At PHIOGEN, Dr. Das focuses on developing scalable solutions that bridge the gap between discovery, manufacturing, and market readiness, with the vision of making phages a distinct standard of care beyond antibiotics.
Commercialization and Market Pathways
The session explored the “business side of phage therapy”— a crucial aspect in the journey of phage therapy from research to real-world healthcare solutions. and Phage therapy is gaining renewed global attention as a promising alternative to antibiotics, translating this scientific potential into viable healthcare products requires more than laboratory innovation—it demands robust business models, sustainable investment, and regulatory clarity. This session was structured around topics, including understanding market failures, phages as a standard of care, business models, integrating phages into healthcare systems, manufacturing and building phage-based startups.
Lessons from Antibiotic Failures
The antibiotic market’s collapse, according to Dr. Mayukh, reflects high development costs, unpredictable demand, and limited commercial returns. Phage companies face similar challenges: target-specific treatments, complex manufacturing, and unclear regulatory pathways. To overcome this, Dr.Mayukh advocates “value-based business models” that emphasize patient outcomes and public-private partnerships.
Phages as a New Standard of Care
Phages are fundamentally different from traditional antibiotics. They are evolving, viable, living biologics that are strain-specific, often individualized. Phages are “not static drugs”. Their specificity and adaptability require a shift in how healthcare systems, regulators, and clinicians approach their use. With this in mind, “Phage therapy should be defined as its own therapeutic class with a distinct standard of care, co-developed with regulators, clinicians, and global health agencies”, says Dr.Mayukh which, according to him, can be achieved by integrating phage therapy with rapid bacterial diagnostics, antimicrobial stewardship programs, establishing centralized phage banks, and creating clear reimbursement frameworks.
Dr.Mayukh emphasizes, “Consensus guidelines are needed to standardize treatment protocols, quality control, and operational models”. This can be achieved by establishing collaborative consortia, which in turn can help “establish phages as a new therapeutic class, preventing marginalization as experimental rescue therapies, setting up unified treatment guidelines, and boosting investor confidence.”
Emerging Business Models for Phage Commercialization
Dr. Mayukh outlined several innovative “business models” shaping the future of phage therapy:
- “Subscription-based access (Phage Netflix Model): Hospitals pay for access rather than per dose, ensuring predictable funding.
- Diagnostic-linked therapy: Combining rapid bacterial testing with phage treatment for precision medicine.
- Outcome-based reimbursement: Payment tied to successful infection clearance.
- Platform access models: Offering “Phage-as-a-Service” through centralized libraries and scalable production.”
Dr.Mayukh concludes that such models move beyond volume-based sales and align with global AMR (anti-microbial resistance) stewardship goals.
Building the Phage Ecosystem: From Manufacturing to Regulation
Phage manufacturing remains a bottleneck, with few GMP-certified facilities worldwide. Dr. Mayukh emphasized the need for “hybrid production models”—which can function as centralized phage banks complemented by regional facilities to enable rapid, locally tailored treatments. For example, in Europe, the EMA (European Medicines Agency) supports adaptive pathways and hospital exemption models. The regulatory progress is encouraging: agencies like the FDA (Food and Drug Administration) and EMA are increasingly supportive, treating phages as adaptable biologics. However, published “global guidelines” are still needed to standardize quality, potency, and safety testing, which are key factors for the investors and regulatory confidence.
However, across the world, Dr.Mayukh says, “there are limited GMP-certified facilities worldwide capable of producing phage products at scale. Especially the scarcity is acute in LMICs (Low and Middle Income Countries), where local phage production plants are virtually non-existent, leading to reliance on imports. However, in high-income countries, though biomanufacturing infrastructure exists, regulatory guidelines are sometimes lacking.”
All these, along with infrastructure gaps, contribute to slow scale-up and high production costs. Another major hurdle in manufacturing is standardization and quality control (purity, endotoxin removal, sterility, potency assays) due to phage variability and mutability. Dr.Mayukh emphasized the need to have “published guidelines from regulators to build investor and regulatory confidence.”
Centralized vs. Local Production Models
As we move on with our discussion about various production models to increase the outreach of phage therapy to the patients more quickly, Dr.Mayukh Das advised on centralized, decentralized, and hybrid production models.
- “Centralized production: Offers economies of scale and superior production for standardized phage cocktails, but may be less responsive to emerging resistance patterns.
- Local/decentralized production (e.g., on-site hospital or regional biomanufacturing units): Enables rapid response and tailored phage formulation, particularly beneficial in LMICs.
- Hybrid models: Combine centralized phage banks (supplying standardized backbones) with regional labs (adapting formulations for local needs).
- Investment in both centralized and decentralized structures is needed to ensure effective and sustainable phage therapy access globally.”
Global Collaboration: Toward a Phage Alliance
Dr. Mayukh called for a “global phage alliance” to unify efforts among organizations such as The Phage, Phage Hunters Training Research Program(PHTRP), and other phage teams across the world. These collective platforms could streamline data sharing, regulatory harmonization, and phage library development.
Dr. Mayukh highlighted key pillars for building a successful phage startup
- To plan clear milestones and market entry strategies to attract investors,
- Identify unmet medical needs and a viable business model,
- Develop strong IP protection for phage discovery and formulation platforms and
- Build the right team of scientific, clinical, and regulatory experts”.
The key takeaways from this enlightening and engaging webinar were, it is important to define phages as a standard of care distinct from antibiotics, to integrate diagnostics and precision medicine, build robust reimbursement and investment models, and achieve these objectives by leveraging public-private partnerships for early-stage funding.
“Even complex, personalized therapies can achieve commercial success if we align science with strategy,” concluded Dr. Mayukh.
Day 3: GMP, Manufacturing, and Production in Phage Development — Dr. Frank Smrekar | World Phage Week Webinar Series | The Phage & PHTRP
Friday, October 24, 2025, 8:00 – 9:30 pm
Time zone: Africa/Nairobi
