BACTERIOPHAGES

Bacteriophage development for targeted antimicrobial solutions

Developments in human health, animal health and agriculture to support new approaches to antibiotic resistance and major bacterial pathogens.

Fluart Innovative Vaccines Ltd. has been developing bacteriophage-based solutions for nearly a decade: from isolation and characterisation to manufacturing technology and scale-up, through to the development of targeted phage cocktails, formulations and analytical systems.

100+ selected bacteriophages underpinning our development activities
3 key areas of application
GMP manufacturing and quality assurance capabilities

BACTERIOPHAGE · SCHEMATIC ILLUSTRATION

A TARGETED BIOLOGICAL APPROACH

Why bacteriophages?

Antimicrobial resistance increasingly limits the effectiveness of conventional antibiotic treatments.

Bacteriophages are viruses that infect bacteria. When appropriately selected and developed, they can specifically inhibit the growth of particular bacteria or destroy bacterial cells.

Phages may therefore complement antibiotics in certain applications and provide a basis for alternative approaches in specific situations.

Researcher with a Petri dish in a laboratory – illustrative image
1

Isolation and characterisation

Isolation of new bacteriophages and investigation of their host range, phenotypic characteristics and genetic properties.

2

Phage and bacterial strain bank

Clinical, environmental and reference bacterial strains, together with more than 100 selected bacteriophages.

3

Phage cocktails

Development of targeted, multicomponent combinations for broader coverage of relevant bacterial strains.

4

Formulation

Development of formulations and protective matrix systems to support stability and practical use.

5

Scale-up

Development and scale-up of manufacturing processes, integrated into a reproducible technology platform.

6

Analytics and quality

Stability, activity and quality testing, together with the development of specifications and analytical methods.

Key bacterial targets

Salmonella Infantis Salmonella Enteritidis Escherichia coli Staphylococcus aureus

The development platform may be particularly relevant to programmes targeting multidrug-resistant bacteria, hospital-acquired infections, enteric bacterial problems in livestock production and Salmonella risks along the food chain.

AREAS OF APPLICATION

Three focus areas, one development platform

01

Human health

Developments targeting difficult-to-treat bacterial infections, infections with a limited response to antibiotics and hospital-acquired infections.

02

Animal health

Developments targeting Salmonella, E. coli and Staphylococcus for flock and herd treatment, hygiene and food safety applications.

03

Agriculture and the food chain

Targeted biological control along the food chain and, in the longer term, against bacterial plant pathogens.

01 • HUMAN HEALTH

Developments targeting difficult-to-treat bacterial infections

One of the most important potential applications of bacteriophage development for human health is the treatment of infections that do not respond, or respond only to a limited extent, to antibiotics.

These may include infections caused by multidrug-resistant strains, recurrent bacterial diseases and hospital-acquired infections associated with healthcare settings.

Salmonella Infantis Staphylococcus aureus Escherichia coli AMR pathogens
Laboratory work – scientist mixing substances
MANUFACTURING AND QUALITY

Development of reproducible, well-characterised phage active substances

A key foundation of the development pathway towards human use is a phage active substance of appropriate quality that can be controlled and manufactured reproducibly.

Genetic and phenotypic characterisation
Determination of host range
Assessment of lytic activity
Investigation of resistance development
Control of bacterial production strains
Validation of manufacturing and purification processes
Control of endotoxins and bacterial residues
Active substance and product stability
Reference materials and specifications
Development of analytical methods

Regulatory considerations

The development of bacteriophage therapy for human use requires appropriate quality, non-clinical and clinical evidence. Laboratory activity alone does not demonstrate suitability for human therapeutic use or clinical efficacy.

CLINICAL DEVELOPMENT PATHWAY

From the target pathogen to the clinical programme

Target pathogens

Identification of clinically relevant bacterial strains and therapeutic targets.

Phage selection

Isolation and characterisation of phages and assembly of suitable phage cocktails.

Formulation

Development of stable, manufacturable and controllable active substance and product formulations.

Preclinical development

Conduct of safety, pharmaceutical and preclinical studies.

Clinical trials

Clinical programmes designed for an appropriate patient population.

Regulatory strategy

Preparation of documentation and a development strategy aligned with regulatory requirements.

Animal health research – illustrative image from the Fluart website
02 • ANIMAL HEALTH

Targeted solutions against major animal health pathogens

The spread of resistant bacterial strains makes it increasingly important to reduce antibiotic use and develop alternative antimicrobial technologies.

Fluart’s animal health development activities aim to create bacteriophage-based products for use against bacteria of economic, animal health and food safety significance.

POULTRY SECTOR

Phage cocktails against Salmonella

Salmonella Infantis and Salmonella Enteritidis may pose animal health, food safety and public health risks simultaneously. Prevention is therefore a priority from the livestock rearing and production stages onwards.

Fluart has developed several bacteriophage cocktails targeting Salmonella Infantis and Salmonella Enteritidis. Multicomponent cocktails may enable coverage of a broader spectrum of bacterial strains.

Planned applications

  • Treatment of broiler and laying flocks through drinking water
  • Spray application on livestock farms
  • Reduction of environmental Salmonella loads
  • Targeted surface treatment in slaughterhouses and meat processing facilities
  • Complementing existing cleaning and disinfection protocols

Efficacy: application-specific validation is required

The effectiveness of bacteriophage treatments is strongly influenced by the characteristics of the specific phage–bacterium–food or phage–bacterium–environment system. Demonstrating efficacy in the target animal species under the intended conditions of use is therefore a key element of development.

FORMULATION

Oral administration and protection against acidic pH

The acidic environment of the stomach is a major technological challenge for orally administered phage products. The activity of many bacteriophages may decrease at low pH, directly affecting their practical applicability.

Fluart has developed a multicomponent protective matrix formulation to improve phage stability in acidic environments, helping a greater proportion of phages retain their infectivity during passage through the digestive tract.

Formulation development objectives

  • Supporting the control of enteric Salmonella infections
  • Practical implementation of flock and herd treatments
  • Improving shelf life and technological stability
  • Preparing applications as feed and drinking water additives
FURTHER DEVELOPMENT DIRECTIONS

E. coli, Staphylococcus aureus and endolysins

Enteric E. coli

Targeted development opportunities relating to enteric E. coli infections in the poultry and pig sectors.

Staphylococcus aureus

Investigation of flock and herd hygiene applications and potential udder health applications.

Endolysin technology

Development approaches using bacteriophage enzymes that break down bacterial cell walls.

Bacterial mastitis – integrated Guide project

The GINOP_PLUSZ-2.1.1-24-2025-00012 project aims to develop an integrated professional guide and decision support system that brings development and application processes for tackling bacterial mastitis into a unified framework.

The Guide is a professional protocol system designed for cattle breeders, veterinarians, researchers and pharmaceutical manufacturers. It organises development steps, testing methods and decision points into an integrated decision tree, with particular emphasis on the combined use of bacteriophages and endolysins.

Bacteriophage research and Salmonella – illustrative image
03 • AGRICULTURE AND THE FOOD CHAIN

Biological control from production to processing

Agricultural applications may support the reduction of bacterial loads along the food chain and, in the longer term, the targeted biological control of bacterial plant diseases.

Fluart’s strongest current focus in this area is on the poultry sector, Salmonella control, and hygiene in slaughterhouses and meat processing facilities.

FOOD SAFETY

A targeted addition to hygiene systems

Phage applications in the food industry may specifically target bacterial load reduction in technological settings where supplementing existing hygiene processes is warranted.

  • Environmental treatment on poultry farms
  • Complementing slaughterhouse hygiene technologies
  • Targeted surface treatment in meat processing facilities
  • Reducing the spread of Salmonella throughout the chain
  • Validation and monitoring of integrated hygiene protocols

An integrated approach

Bacteriophages do not automatically replace standard cleaning, disinfection, microbiological monitoring or good manufacturing practices.

Successful application requires phage treatment to be properly integrated into the biosecurity system of the farm or processing facility, with its effects supported by targeted studies.

CROP PROTECTION OUTLOOK

Targeted phages against bacterial plant pathogens

Bacteriophages may also be developed as a potential biological crop protection technology to control specific bacterial plant pathogens.

International development programmes are investigating phage products against species of Xanthomonas, Pseudomonas, Ralstonia and Erwinia, among others. Fluart’s existing phage platform and formulation expertise may also provide a basis for such crop protection developments in the future.

Targeted isolation

Selection of bacteriophages active against plant-pathogenic bacteria.

Phage cocktails

Development of multicomponent systems to support an appropriate host range.

Application formulations

Formulations adapted for foliar treatment, irrigation or seed treatment.

Stabilisation

Systems that support stability against UV exposure, heat and desiccation stress.

Integrated pest management

Biological control solutions incorporated into integrated pest management systems.

Partner-based validation

Greenhouse and field validation programmes with agricultural partners.

Environmental stability is a key consideration

In plant environments, phage activity may be influenced by UV radiation, desiccation, temperature fluctuations, pH, rainfall, adhesion to leaf surfaces and the presence of the target bacterium, among other factors. Formulation and application technology are therefore central to development.

RESEARCH AND DEVELOPMENT PARTNERSHIP

Collaborating on the development of next-generation bacteriophage solutions

Fluart seeks collaboration with clinical centres, microbiology laboratories, animal health and agricultural organisations, pharmaceutical development partners and research institutions to carry out validation, clinical or European Union development programmes.

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