Intralytix: Revolutionizing Healthcare and Food Safety with Cutting-Edge Bacteriophage Technology

In an exclusive interview with Biz Tech Outlook, the leadership team at Intralytix, Inc. shares how their groundbreaking bacteriophage technology is redefining healthcare and food safety—earning them a spot on our cover and recognition as one of the Top Fastest Growing Companies to Watch in 2025.

Can you provide a brief introduction to Intralytix, including its mission and core areas of expertise?

Intralytix Inc., established in 1998, is a pioneering biotechnology company based in the United States, specializing in the development and commercialization of bacteriophage-based products. Their mission is to harness the natural antibacterial properties of bacteriophages—viruses that specifically target and eliminate harmful bacteria—to address bacterial pathogens across various sectors, including environmental, food processing, and medical settings.

Founded by Dr. Alexander Sulakvelidze and Dr. J. Glenn Morris, Jr., Intralytix has evolved from a modest startup development, Intralytix remains at the forefront of bacteriophage technology, committed to improving public health and food safety worldwide. into a revenue-generating, clinical stage company. The company operates from a state-of-the-art facility in Columbia, Maryland, equipped with high-throughput robotic capabilities and the largest cGMP manufacturing capacity in the U.S. for FDA-approved bacteriophage products. Notably, Intralytix was the first company globally to receive FDA approval for a phage-based food safety product, ListShield™, in 2006.

Intralytix’s core expertise lies in creating innovative bacteriophage solutions as sustainable and effective alternatives to traditional antibiotics and antimicrobial agents. Their product portfolio addresses various applications, such as controlling Listeria monocytogenes contamination in foods and food processing facilities.

Through continuous research and development, Intralytix remains at the forefront of bacteriophage technology, committed to improving public health and food safety worldwide.

What distinguishes Intralytix from other companies in the biotechnology and bacteriophage space?

Intralytix distinguishes itself in the biotechnology and bacteriophage sectors through its pioneering efforts and sustained leadership in bacteriophage-based solutions. Established in 1998, it stands as the oldest phage-focused company in the United States, reflecting the visionary approach of its founders during a period when phage therapy was largely unrecognized.

Key achievements that set Intralytix apart include:

• Regulatory Milestones: Intralytix was the first globally to establish a Master Drug File with the FDA’s Center for Biologics Evaluation and Research for phage manufacturing suitable for human clinical applications. Additionally, it received the f irst FDA and USDA approvals for a phage product designed for food safety applications. The company now boasts the world’s largest portfolio of FDA- and USDA-approved phage products targeting major foodborne bacterial pathogens.
• Commercial Success: Intralytix is among the few phage companies worldwide generating revenue from FDA-approved products. The firm has experienced significant growth, with an 800% increase in food safety product sales over the past 7-8 years and a 76% rise between 2023 and 2024. Notably, Intralytix achieved profitability in 2024, a unique accomplishment in the phage industry, with expectations of continued profitability in 2025 and beyond.

These milestones underscore Intralytix’s commitment to innovation, regulatory excellence, and commercial viability, solidifying its leadership in the bacteriophage domain.

Could you highlight some of your key products or solutions and their impact on various industries?

Intralytix offers a diverse range of bacteriophage based products that have significantly impacted multiple industries, particularly in food safety and nutraceuticals.

food safety Solutions

Intralytix has developed the world’s largest portfolio of phage-based products targeting major foodborne bacterial pathogens. These products are Kosher- and Halal-certified, with most also OMRI-listed for organic food production. Regular use has enabled food processing companies to enhance safety ratings, often improving from Category 3 to Category 2 or 1, thereby reducing costs and mitigating negative publicity.

Key products include:

• ListShield™: The first FDA-approved phage product for food safety, targeting Listeria monocytogenes. Recognized by the USDA as a “processing aid,” it requires no labeling and also approved for use in Canada and Israel.
• SalmoFresh™: Targets Salmonella species and also approved for use in Canada and Israel.
• ShigaShield™: Addresses contamination by Shigella species, with FDA and USDA approval for direct application to various foods without labeling requirements.
• CampyShield™: Targets Campylobacter species, approved by the FDA and USDA for direct food application without labeling requirements.
• EcoShield™ (EcoShield™ PX): Effective against Shiga toxin producing E. coli (STEC), including O157:H7 and all “big six” serotypes; also approved for use in Canada and Israel.

These products, when properly applied, significantly reduce or eliminate contamination in foods, enhancing safety and quality.

Nutraceutical Applications

Intralytix has pioneered PhageBiotix™ and SuperBiotix™ technologies, developing bacteriophage-based tools to modulate the microbiome for various health benefits. This innovative approach extends beyond traditional phage therapy, offering potential solutions for conditions such as obesity, Alzheimer’s disease, dental caries, and certain cancers. Phages can be customized individually (PhageBiotix™) or combined with traditional probiotics and other active compounds (SuperBiotix™). Produced in Intralytix’s cGMP facility compliant with 21 CFR 117 standards, these dry-form phages have a shelf life exceeding 24 months at room temperature.

Intralytix’s commitment to innovation and quality has established it as a leader in bacteriophage applications across various industries, providing effective and sustainable solutions to complex bacterial challenges.

Can you share insights into your leadership philosophy and the role of your team in driving success?

Dr. Alexander “Sandro” Sulakvelidze, President and CEO of Intralytix, Inc., emphasizes a leadership philosophy centered on empowering his team. He believes in hiring the right individuals and granting them the autonomy to operate without micromanagement, while remaining available to provide assistance when necessary.

Intellectual Property: Intralytix’s patent strategy is based on a multi-prong approach, which provides broad and strong protection ranging from protecting specific bacteriophages and their combinations (including in blends with traditional yeast- and/or bacteria based probiotics) that serve as the cornerstone of various Company products to methods and applications of those bacteriophages in various settings. Intralytix currently has 15 issued patents and several pending patent applications. However, the company’s most formidable intellectual property protection stems from its know-how, which combines extensive experience in phage related technologies with advanced programs and algorithms that enable the design of highly effective phage cocktails and scalable production under cGMP conditions. Noteworthy among these proprietary programs are PhageSelector™ and AI-powered PhageEngine™, developed by Bradley Anderson, VP for Production and Logistics at Intralytix.

PhageSelector™ is Intralytix’s proprietary program designed to streamline the process of creating optimal phage cocktails by analyzing panels of phage efficacy data in combination with many other parameters. PhageSelector™ has been instrumental in the development of all of Intralytix’s commercial products for food safety, as well as the phage formulations for the clinical trials currently sponsored by the Company. This program provides an unparalleled level of sophistication in designing highly effective phage cocktails and blends tailored for different applications.

PhageEngine™ is an AI-based platform that offers a framework for optimizing phage-host growth dynamics and scaling up production processes. Partially funded by the NIAID, NIH, PhageEngine™ combines Intralytix’s decades of expertise in phage manufacturing with cutting edge machine learning technologies to enhance phage production. PhageEngine™ has been pivotal in enabling Intralytix to rapidly scale up phage production to over 1,000L fermenter scale, all while ensuring compliance with 21 CFR 117 cGMP standards.

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