Intralytix
Intralytix, Inc. is a biotechnology company dedicated to developing innovative bacteriophage-based products to improve human health and food safety. They focus on applications in food safety, veterinary medicine, human therapeutics, oral care, cosmetics, and dietary supplements. The company has the largest portfolio of FDA-approved bacteriophage products for food safety and is actively advancing phage therapy for medical applications, including clinical trials for drug candidates targeting resistant bacterial infections. They leverage advanced genome sequencing, metagenomics, and AI technologies to engineer genetically modified phages with enhanced activity and patentability. Intralytix collaborates with academic centers and government agencies, such as the NIH and the University of California, San Diego, to support research and development in phage therapy.
Industries
Nr. of Employees
small (1-50)
Patents
Products
Listeria-targeted phage preparation for food surfaces
Multivalent bacteriophage preparation formulated to reduce Listeria monocytogenes contamination on ready-to-eat foods and food-contact surfaces; reported regulatory clearances for food use.
Salmonella-targeted phage preparation for meat and processing environments
Phage-based preparation formulated to reduce Salmonella spp. contamination on raw meat and poultry and in processing environments; used as a non-chemical antimicrobial for food processing.
STEC-targeted phage preparation for food safety
Bacteriophage preparation formulated to reduce Shiga toxin–producing E. coli (including O157:H7 and other serotypes) on foods and in processing environments.
Campylobacter-targeted phage preparation for poultry and red meat
Preparation of bacteriophages active against Campylobacter species for application to raw red meat and poultry to reduce Campylobacter contamination; reported recognition for food use.
Shigella-targeted phage preparation (investigational product)
Phage preparation developed for prevention or treatment of Shigella infections and cleared for clinical investigation under an IND for Phase I/IIa clinical trials.
VRE-targeting phage preparation (IND-authorized clinical candidate)
Bacteriophage preparation intended to manage colonization of vancomycin-resistant Enterococcus (VRE) in the human gastrointestinal tract; cleared by regulatory authority for IND-directed Phase 1/2a randomized double-blind trials.
Listeria-targeted phage preparation for food surfaces
Multivalent bacteriophage preparation formulated to reduce Listeria monocytogenes contamination on ready-to-eat foods and food-contact surfaces; reported regulatory clearances for food use.
Salmonella-targeted phage preparation for meat and processing environments
Phage-based preparation formulated to reduce Salmonella spp. contamination on raw meat and poultry and in processing environments; used as a non-chemical antimicrobial for food processing.
STEC-targeted phage preparation for food safety
Bacteriophage preparation formulated to reduce Shiga toxin–producing E. coli (including O157:H7 and other serotypes) on foods and in processing environments.
Campylobacter-targeted phage preparation for poultry and red meat
Preparation of bacteriophages active against Campylobacter species for application to raw red meat and poultry to reduce Campylobacter contamination; reported recognition for food use.
Shigella-targeted phage preparation (investigational product)
Phage preparation developed for prevention or treatment of Shigella infections and cleared for clinical investigation under an IND for Phase I/IIa clinical trials.
VRE-targeting phage preparation (IND-authorized clinical candidate)
Bacteriophage preparation intended to manage colonization of vancomycin-resistant Enterococcus (VRE) in the human gastrointestinal tract; cleared by regulatory authority for IND-directed Phase 1/2a randomized double-blind trials.
Services
Isolation and characterization of bacteriophages from environmental sources combined with high-throughput screening to identify candidates active against specified bacterial targets.
Scale-up fermentation, downstream purification and production of high-titer bacteriophage preparations under manufacturing quality systems aligned with cGMP principles.
Preparation and management of regulatory filings (food-notification and IND submissions) and operational support for IND-authorized clinical trials, including sponsor responsibilities and clinical operations.
Development of machine learning algorithms and an AI-supported platform integrating big data and high-throughput robotics to define scale-independent manufacturing parameters for high-titer phage production; project supported by NIH SBIR funding.
Development and commercialization services for oral phage-containing dietary supplements and probiotic pills intended to modulate gut microbiome resistance to pathogenic bacteria.
Isolation and characterization of bacteriophages from environmental sources combined with high-throughput screening to identify candidates active against specified bacterial targets.
Scale-up fermentation, downstream purification and production of high-titer bacteriophage preparations under manufacturing quality systems aligned with cGMP principles.
Preparation and management of regulatory filings (food-notification and IND submissions) and operational support for IND-authorized clinical trials, including sponsor responsibilities and clinical operations.
Development of machine learning algorithms and an AI-supported platform integrating big data and high-throughput robotics to define scale-independent manufacturing parameters for high-titer phage production; project supported by NIH SBIR funding.
Development and commercialization services for oral phage-containing dietary supplements and probiotic pills intended to modulate gut microbiome resistance to pathogenic bacteria.
Expertise Areas
- Bacteriophage discovery and library curation
- Phage biocontrol for food safety
- Large-scale phage manufacturing and downstream purification
- AI/ML-driven manufacturing platform development
Key Technologies
- Bacteriophage isolation and host-range characterization
- High-throughput robotic screening
- Large-scale fermentation (industrial bioreactors)
- Downstream purification of viral preparations
News & Updates
Intralytix receives FDA regulatory clearance for Campylobacter technology
Intralytix's CampyShield™ received GRAS recognition from the FDA, enabling its use as an antimicrobial on raw meat and poultry.
Intralytix receives FDA clearance for Shigella bacteriophage product
ShigActive™ received FDA clearance for clinical trials to evaluate its safety and efficacy against Shigella infections.
Intralytix receives FDA regulatory clearance for expanded use of EcoShield™ in grain products
The FDA granted a supplement to its GRAS status for EcoShield™ for use in grain and grain products.
Intralytix awarded European patent for Shigella bacteriophages
The company received a patent covering its bacteriophages targeting Shigella spp. and their applications.
Intralytix receives FDA approval for investigational new drug application for Shigella phage therapy
The company announced FDA approval for clinical trials of ShigActive™ to treat Shigella infections.
Intralytix receives FDA regulatory clearance for phage-based Campylobacter technology
The FDA approved CampyShield™ for managing Campylobacter contamination in food.
Intralytix receives FDA regulatory clearance for Campylobacter technology
Intralytix's CampyShield™ received GRAS recognition from the FDA, enabling its use as an antimicrobial on raw meat and poultry.
Intralytix receives FDA clearance for Shigella bacteriophage product
ShigActive™ received FDA clearance for clinical trials to evaluate its safety and efficacy against Shigella infections.
Intralytix receives FDA regulatory clearance for expanded use of EcoShield™ in grain products
The FDA granted a supplement to its GRAS status for EcoShield™ for use in grain and grain products.
Intralytix awarded European patent for Shigella bacteriophages
The company received a patent covering its bacteriophages targeting Shigella spp. and their applications.
Intralytix receives FDA approval for investigational new drug application for Shigella phage therapy
The company announced FDA approval for clinical trials of ShigActive™ to treat Shigella infections.
Intralytix receives FDA regulatory clearance for phage-based Campylobacter technology
The FDA approved CampyShield™ for managing Campylobacter contamination in food.