Phage CDMO Services — Therapeutics and Enzymes from Discovery to GMP
End-to-end development and GMP manufacturing for bacteriophage therapies and phage-derived enzymes.
At Elise Biopharma, we provide contract development and manufacturing services for the rapidly growing field of phage-based therapeutics. Whether you’re developing a bacteriophage cocktail for antimicrobial resistance (AMR), an engineered phage for oncology, or phage-derived lysins and depolymerases as recombinant biologics, our microbial platforms deliver the scalability, purity, and regulatory readiness required to move from preclinical validation into clinical trials and commercial supply.
Phage products present unique challenges: host-strain selection, lysogeny control, endotoxin burden, and genome stability under scale-up. Our team combines deep microbial fermentation expertise with advanced QC, regulatory dossier support, and aseptic fill-finish capabilities to help you overcome these hurdles. From discovery libraries to GMP lots, we provide a turnkey phage CDMO pipeline that accelerates your route to patients.
A Trusted Partner for Phage Innovators
The phage therapeutics and enzyme market is rapidly diversifying, spanning clinical infectious disease, microbiome modulation, and synthetic biology. We partner with organizations across this spectrum, including:
- Phage biotech startups developing cocktails against multidrug-resistant pathogens or hospital-acquired infections
- Biopharma companies engineering phages with CRISPR payloads, anti-tumor properties, or immune-modulating functions
- Recombinant enzyme developers producing lysins, depolymerases, or tailspike proteins as protein therapeutics or veterinary agents
- Food and agriculture innovators applying phages and phage enzymes for food safety, livestock disease, or crop microbiome stability
- Academic and translational groups seeking scalable GMP production for phage clinical trials or compassionate use programs
With Elise Biopharma, you’re not just outsourcing phage manufacturing—you’re securing a partner with the platforms, analytics, and regulatory insight to make phages a clinical reality.
Phage Therapeutics & Enzymes CDMO Services
End-to-end development and GMP manufacturing for bacteriophage therapies and phage-derived enzymes.
Overview
At Elise Biopharma, we specialize in contract development and manufacturing (CDMO) solutions for the rapidly emerging field of phage-based therapeutics and phage-derived enzymes. Phages are no longer niche research tools; they are advancing toward mainstream clinical adoption as targeted antimicrobials, microbiome modulators, and precision biologics. In parallel, phage proteins such as lysins, depolymerases, and tailspike enzymes are being developed as novel therapeutics for infectious disease, oncology, veterinary applications, and food safety.
Unlike conventional biologics, phages and phage-derived enzymes face distinct challenges: host-strain engineering, lysogeny control, genome stability under large-scale fermentation, removal of host contaminants and endotoxin, and stringent QC tailored to viral and protein modalities. Elise Biopharma provides a turnkey platform that integrates microbial fermentation, advanced purification, analytical QC, regulatory dossier support, and sterile fill-finish—all under one roof.
With Elise, you are not only outsourcing manufacturing—you are partnering with a team that understands the complexity of phage development from discovery through commercialization.
Why Phages and Phage Enzymes Matter
The urgency of antimicrobial resistance (AMR) has reawakened interest in bacteriophages, the natural predators of bacteria. Unlike broad-spectrum antibiotics, phages offer specificity, adaptability, and the ability to co-evolve with their targets. Engineered phages are further expanding this utility, enabling payload delivery, immune modulation, and tumor targeting.
Meanwhile, phage-derived enzymes—such as endolysins, depolymerases, and polysaccharide hydrolases—are advancing as recombinant biologics. These proteins can bypass resistance mechanisms, rapidly lyse bacterial cell walls, and be engineered for spectrum, stability, or reduced immunogenicity.
Together, phages and their enzymes represent one of the most promising next-generation anti-infective platforms. But they also bring manufacturing challenges that conventional CDMOs are not equipped to solve. Elise Biopharma was built to address this gap.
A Trusted Partner for Phage Innovators
Looking for a Phage CDMO? Email us at Info@elisebiopharma.com
We collaborate with organizations across the phage ecosystem, including:
- Biotech startups building targeted phage cocktails against multidrug-resistant pathogens or hospital-acquired infections.
- Biopharma companies engineering designer phages with CRISPR payloads, tumor lytic properties, or microbiome modulation functions.
- Protein therapeutic developers producing recombinant lysins, depolymerases, and tailspike proteins at clinical and commercial scale.
- Food and agriculture innovators deploying phages and enzymes for food safety, livestock disease prevention, aquaculture, and crop microbiome management.
- Academic and translational groups seeking GMP-compliant lots for clinical trials or compassionate use programs.
Our Phage CDMO Capabilities
Discovery to GMP Pipeline!
We offer end-to-end development, from discovery through commercial launch:
- Phage Discovery & Library Construction – Host-range screening, genome characterization, lysogeny/virulence profiling, and engineering support.
- Phage Cocktail Development – Rational design of broad-spectrum or combination phage formulations for AMR pathogens.
- Process Development – Host strain optimization, fermentation design (batch, fed-batch, or continuous), and control of phage amplification kinetics.
- Purification & Polishing – Ultrafiltration, chromatography (AEX, SEC, HIC), and proprietary endotoxin removal workflows.
- GMP Manufacturing – Clinical- and commercial-scale fermentation suites with aseptic fill-finish for vials, syringes, or lyophilized formulations.
- QC & Analytics – Potency, host-range, genome stability, endotoxin, sterility, and phage particle counts.
Phage-Derived Enzyme Production
Our microbial expression systems (E. coli, Pichia pastoris, and custom strains) are optimized for high-yield, high-purity production of recombinant phage proteins:
- Endolysins for Gram-positive and Gram-negative bacteria.
- Depolymerases for biofilm and capsule degradation.
- Tailspike enzymes with binding specificity for resistant pathogens.
Capabilities include:
- Synthetic biology strain design for codon-optimized expression.
- Fed-batch and perfusion fermentation at titers >10 g/L.
- Refolding and polishing workflows tailored to preserve activity and minimize endotoxin.
- ISO 13485-grade enzymes for diagnostic applications.
Formulation Support for Phages and Enzymes
Different applications demand tailored formulation strategies:
- Injectables – Stable phage cocktails for intravenous, intranasal, or intramuscular administration.
- Oral Delivery – Enzyme and phage formulations resistant to gastric acid and bile salts.
- Topical Formulations – Ointments, sprays, and wound dressings with stability across temperature and moisture conditions.
- Lyophilized Products – Freeze-dried formats for long-term stability and global shipping.
We provide viscosity, solubility, and pH optimization for human, veterinary, and agricultural applications.
Analytical & QC Expertise
Phages and their enzymes demand specialized QC beyond conventional biologics. Elise Biopharma offers:
- Host-range profiling – Measuring infectivity across pathogen panels.
- Genome stability assays – Sequencing-based QC to confirm phage identity.
- Particle quantification – Plaque assays, qPCR, NGS, TEM imaging.
- Enzyme potency – Custom activity assays for lysins and depolymerases.
- Endotoxin removal verification – EU <0.1 mg⁻¹ standard routinely achieved.
- Sterility & adventitious agent testing – GMP-compliant release assays.
Scale-Up & Manufacturing
We support phage and enzyme programs from bench scale to commercial readiness:
- Bench-scale – 2 L, 10 L, and 20 L feasibility runs.
- Pilot scale – 50–200 L process development and engineering batches.
- GMP scale – 500–2,000 L suites for phage fermentation and recombinant enzyme production. (If needed our partners have scales up to 100,000 liters)
- Aseptic fill-finish – Vials, pre-filled syringes, or cartridges in Grade A isolators.
- Lyophilization – Dedicated lyo capabilities with full stability testing.
Our teams ensure lot-to-lot consistency, validated processes, and full regulatory traceability.
Regulatory & Clinical Support
Phages and phage-derived proteins face fragmented regulatory frameworks across the globe. Elise Biopharma provides guidance and dossier support for major jurisdictions:
- FDA (CFR, CBER) – Guidance for biologics and bacteriophage investigational new drug (IND) submissions.
- EMA (EU GMP, ATMP) – Support for clinical trial authorization (CTA) and novel biologics.
- Phage-specific frameworks – Experience with early-stage phage approval pathways in Eastern Europe and compassionate use programs worldwide.
- ISO & VICH standards – Support for veterinary and agricultural phage products.
We ensure your program is CMC-ready, with defensible documentation and validated data packages.
Innovation & Differentiation
Elise Biopharma stands apart by combining deep microbial expertise with a commitment to niche biologics:
- Precision Fermentation – AI-driven process control for reproducible phage titers and enzyme yields.
- Hybrid Microbial/Mammalian Systems – For engineered phages requiring mammalian payload packaging.
- Analytical Leadership – Full in-house HR-MS, NGS, electron microscopy, and potency assays.
- End-to-End Integration – Discovery, development, GMP manufacturing, QC, and regulatory support under one roof.
- Global Reach – Clinical and commercial supply chains, with LN₂ logistics and cold-chain partners worldwide.
Filamentous Bacteriophage Services (M13, f1)
At Elise Biopharma, we expand beyond classical lytic phage platforms to offer specialized expertise in filamentous bacteriophages, particularly the widely used M13 and f1 families. Unlike virulent phages such as T4, filamentous phages are non-lytic, enabling continuous replication within host bacteria without killing the cell. This unique biology makes them invaluable in advanced biotechnology applications, from molecular display technologies to therapeutic scaffolding and nano-engineering.
Filementous Applications and Expertise
- Phage Display Platforms:
We engineer and produce M13/f1 phages as versatile display vehicles for peptides, antibodies, and protein fragments. Our workflows integrate cloning, packaging, and library amplification under controlled conditions, ensuring high fidelity and diversity for discovery campaigns. - Vaccine and Immunotherapy Scaffolds:
Filamentous phages provide a safe, repetitive antigen-display surface ideal for next-generation vaccines. We design and manufacture customized scaffolds that enhance immunogenicity, stability, and dose consistency, with the flexibility to scale from R&D prototypes through GMP readiness. - Nanomaterial and Synthetic Biology Applications:
The rod-like geometry and self-assembling properties of filamentous phages make them natural templates for nanowires, coatings, and advanced biomaterials. Our team supports custom functionalization and downstream integration into nanotechnology workflows.
Service Offerings
- Custom Strain and Vector Engineering – Tailored design of M13/f1 vectors, optimized for insert stability and expression fidelity.
- Library Construction & Screening – Development of diverse phage display libraries with high complexity and robust amplification performance.
- Analytical Characterization – Comprehensive QC including TEM visualization, infectivity assays, sequencing validation, and display quantification.
- Process Development & Scale-Up – Scalable fermentation and downstream processing optimized for filamentous phage propagation.
- GMP & Regulatory Support – Transition from research-grade materials to GMP production with full documentation and compliance pathways for vaccine or therapeutic programs.
Why Innovators Choose Elise Biopharma
Phage companies and recombinant enzyme developers choose Elise because we combine:
- Technical expertise – decades of microbial fermentation experience adapted for phage biology.
- Flexible infrastructure – scalable from research to commercial volumes.
- Cost-effective models – optimized for startups and large pharma alike.
- Specialized QC – assays designed specifically for phages and phage proteins.
- Regulatory literacy – navigating fragmented frameworks with confidence.
Whether you’re developing a targeted phage cocktail, a lysin therapeutic, or an engineered phage-enzyme hybrid, Elise Biopharma provides the speed, rigor, and partnership you need to succeed.
Phages and phage-derived enzymes are rewriting the future of anti-infectives, diagnostics, and food safety. But their complexity demands a CDMO partner with deep microbial expertise, tailored QC, and regulatory foresight.
At Elise Biopharma, we provide that foundation—transforming promising phage programs into clinical and commercial realities.
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Contact us today to discuss your next phage project and explore how Elise Biopharma can accelerate your path to patients.
Email our team at info@elisebiopharma.com