By Dr. Becker
My first guest this morning is Dr. Alexander Sulakvelidze. He goes by Sandro. Sandro is Chief Scientist at Intralytix, Inc., and an internationally recognized expert in phage technology, which is the topic of our interview this morning.
Bacteriophage (Phage) Technology: A Way to Kill Pathogenic Bacteria Without Also Killing Beneficial Bacteria
First, I asked Sandro to explain a little about phage technology and the services Intralytix offers.
“The company was formed to develop various types of products based on the phage platform technology,” he replied. “For people who don't know what bacteriophages or phages are, they are bacterial viruses.
They are actually the oldest known organisms on this planet, probably existed around three billion years ago, and are arguably the most ubiquitous organisms on earth. The estimates vary, but they are typically in the range of 10 to the 30th, 10 to the 32nd, so that's a lot of zeros if you think about it.
They are viruses that kill bacteria, and bacteria only. Bacteriophages cannot infect human or animal or plant cells, so that makes them very safe for all living things except bacteria.”
They're also very specific. If you think about antibiotics, antibiotics kill bacteria or slow the growth of bacteria, but they do it for many different types of bacteria, not necessarily just the problem-causing bacteria. They do a miracle job, but they have this characteristic that they are not specific.
Bacteriophages are very specific. They only kill targeted bacteria. That can be a tremendous advantage because we’ve come to realize we don’t want to eliminate all bacteria. As science develops there is an increasing appreciation that we don't want to do that.
Many types of bacteria are good for us, so we really need to find a much more targeted and gentle approach that will kill disease-causing bacteria without killing good bacteria. Bacteriophages allow us to do that.
In a sense, Intralytix was founded to explore the natural characteristics of bacteriophages and see if we can develop different types of products that can take advantage of those characteristics, and target disease-causing bacteria in human foods, pet foods, and many other settings.
I think that's what the future holds — a much more targeted approach to killing disease-causing microbes, as opposed to what I call an H-bomb or nuclear bomb approach.
The H-bomb approach is found in chemical disinfectants, high-pressure sterilization, radiation, and antibiotics. These techniques kill everything bad AND good, as opposed to more of a laser-guided missile approach, which is possible with bacteriophages that target only the bad bacteria and leave the rest intact.”
Phage Technology Capitalizes on a Substance That Already Exists in Nature
One of the main reasons phage technology is so exciting to me is because it capitalizes on something that already exists in nature, namely viruses that specifically and only infect pathogenic bacteria.
“Absolutely,” says Sandro. “In many cases the bacteriophages that we use come from foods. In all cases they come from the environment. They aren’t genetically modified in any way. In fact, interestingly enough, the whole concept is so sophisticated and pure, if you will, that the bacteriophage preparations are kosher, they are halal, they are OMRI listed, which means that they are suitable for organic food production. All we do is put them in the right concentration in the right place.
It's completely, 100 percent natural. If their target is a foodborne bacterium, they'll kill it if it’s present in the food. If there’s no bacterium present, the phages just dissipate. They're naturally present on those foods anyway.”
Bacteriophages Are Being Used to Treat People With GI Disease
Interestingly, I just read an article in a health and wellness magazine about doctors who are starting to use bacteriophages to treat people dealing with life-threatening dysbiosis (leaky gut syndrome). The treatment involves blending specific strains of probiotics with specific strains of bacteriophages to address leaky gut and other chronic diseases of the GI tract in humans, which is very exciting.
“It's interesting history,” says Sandro, “because when the company was formed back in 1998, and I'm one of the co-founders of Intralytix, the idea was to pursue human applications for the technology. Not many people in the Western world realized the potential of bacteriophages.
We quickly realized this was such a novel concept for Western medicine, that it would take an enormous effort to introduce the technology for human therapeutic use. So we shifted our focus to food safety applications at that time, but we’re now considering returning to exploring human therapeutic applications.”
In fact, not to deviate too much from the main story, but we will be starting human clinical trials later this year or early next year, and there are other developmental opportunities in the pipeline.
Phage Technology Is FDA-Approved to Protect Food Against Contamination With Listeria, E. Coli, Salmonella and Shigella Bacteria
Next, I asked Sandro to talk about how Intralytix entered the food safety industry.
“We were the first company in the world to receive FDA approval for a phage-based product for food safety applications,” Sandro explained. “We're very proud of that achievement because there were a lot of skeptics and it had never been done before.
Since that time, we’ve had three additional products approved by the FDA, and usually when approval comes from the FDA it is also approved by the USDA. In the spirit of full disclosure, I should mention that the FDA and USDA don't really approve anything.
People typically use the phrase, ‘FDA approval.’ It's not technically approval. The FDA either does not object to your definition or issues some kind of a definite statutory regulation, but they don't actually ‘approve’ anything. I use the term because most people use it and it’s a common phrase.
The first Intralytix product was FDA approved back in 2006, and targeted listeria monocytogenes, a very deadly Gram-positive bacterium that triggers the disease called listeriosis, which has a high fatality rate of 25 to 30 percent in susceptible populations such as pregnant women and the elderly. There is a zero-tolerance policy for listeria monocytogenes in ready-to-eat foods in the U.S.
What that means for human foods is that if even one cell of listeria is found in 25 grams of ready-to-eat food, that food is considered adulterated and cannot be sold. What we are helping companies do is to make their food safer so that humans don't get sick when they consume it, but also the companies that make those foods can sleep better knowing that their food is safer.
In subsequent years, we received FDA approval of three additional products, so we currently have a total of four FDA-approved products that target typical bad players in the foodborne diseases realm, including listeria, E. coli O157:H7, Salmonella, and Shigella.
More and more food producers are getting on board. There was some initial apprehension because many manufacturers simply don’t know about this technology. But as times goes on and people use it and see all the benefits, I think the number of food producers who want to use it will continue to grow.”
Pet Food Producers Are Also Showing Interest in Bacteriophages
According to Sandro, several pet food companies have also taken a close look at this technology, particularly companies that produce very healthy, untreated, raw food diets for pets. This is certainly where my passion lies, because FSMA, the Food Safety Modernization Act, and the zero tolerance policy also apply to pet foods.
One of my frustrations is that we know kibble is not sterile. In fact, the majority of pet food recalls are for kibble. However, it’s the fresh pet food producers who are under the microscope. Almost all commercial raw pet food companies are small, locally-owned operations that use human-grade meats and other ingredients because they want to provide the freshest, safest products to pet parents.
However, the FSMA has backed them into a corner with the zero tolerance policy. They either have to use HPP (high-pressure pasteurization) to sterilize raw foods, which most aren't interested in doing, or they have to become quite innovative. I actually heard about Sandro and Intralytix through Darwin's Pet Foods. Darwin's decided to use phage technology because they didn’t want to use HPP.
How Phages Differ From Other Pathogen-Killing Technologies
I asked Sandro to explain the difference between HPP and phage technology in terms of how the two processes impact food.
“HPP is a fairly popular intervention, not just for pet food but also in human foods,” he explains, “and of course there are others such as irradiation and chemicals, which are everywhere. Each of those technologies works reasonably well, but obviously not well enough, since we still have numerous foodborne outbreaks and food recalls. Those technologies aren’t ineffective, but they are only effective to a degree. Nothing is 100 percent.
The fundamental difference between those technologies, including HPP, and bacteriophage bio-control is the ability to differentiate bad bacteria from friendly bacteria.
Those other technologies kill all the bacteria in the food. If you’re really looking for sterile food, then irradiation or HPP may be the way to go, but if you’re looking to preserve the full nutritional value of fresh food, realizing that most of the bacteria on those foods is good for you, you don't want to remove them.
In fact, once you remove them, you are losing significant nutritional value. People take probiotics to replenish their normal microflora. A big help in creating healthy microflora comes from eating foods rich in nutrition and beneficial bacteria like those found in probiotic products. By using HPP, you're removing that from the equation. You're trying to get a sterile food.
What bacteriophages do is discriminately kill pathogens but nothing else, so you get this benefit. Your pets get the benefit. They consume foods with their full nutritional value. All the phages did was remove the bad bacteria.
There are additional differences between phage technology and other technologies, one of which is cost. HPP equipment can be very expensive since it’s what’s called an off-conveyor belt process. The prices can vary from 15 to 30 cents per pound. I'm more familiar with human food prices, so the prices may be slightly different for pet food, but I suspect they are in that same ballpark.”
And again, phage technology is organic. It’s kosher, halal, for people interested in those certifications. It maintains the nutritional value of the food, and it doesn’t impact the taste or aroma of the food like other technologies, such as irradiation. But it's not a silver bullet. Bacteriophages have a downside, too.
It’s a very good thing that phages are specific about what they kill, and kill only targeted bacteria. A downside of that specificity is that if a food is contaminated with two types of pathogenic bacteria, and you use a phage that only kills one, you still have the problem with the other. That's something that everybody needs to keep in mind.
There are ways of addressing it. We have different bacteriophage preparations that target different foodborne pathogens, so you can use a combination of those. In most cases, though, it's usually one or two bacterial targets that represent the biggest problem.”
Phage Technology: Safe, Effective, Holistic
In the last few years, the majority of fresh pet food recalls have been for Listeria contamination. And it’s important to mention that dogs and cats are designed by nature to handle foodborne bacteria. This isn’t an issue of pets having a problem with bacteria that's naturally found in the food they’re designed to eat.
The issue is that the law dictates zero tolerance, so the fresh pet food industry must do something. That’s why I so appreciate the innovations Sandro and Intralytix have developed to help keep food safe. The service they provide is invaluable. Phage technology is to date the safest, most effective and definitely most holistic approach to managing pathogenic bacteria in food.
“Our philosophy is that we don’t want to live in a sterile world,” says Sandro. “We don’t want to kill all bacteria. In fact, the majority of bacteria are good for us. This concept that we must sterilize everything is fundamentally wrong.”
I deeply appreciate Sandro’s commitment to a nontoxic, very helpful pet food safety technology. The entire fresh food industry is benefiting from bacteriophage technology.
Raw Bistro Pet Fare: One of the Rare Fully Transparent Pet Food Producers in the Industry
My next guest is Justin Magnuson, and we’ve been friends for many years. Justin is the Vice President of Raw Bistro Pet Fare, and I met Pat Greene, the owner, when she contacted me and she said, "We want you to see the back end of our pet food company." Now, keep in mind this is NOT the norm within the pet food industry.
Very few pet food companies ever extend invitations for the general public or a veterinarian to come in and evaluate sourcing. I flew to Cannon Falls, Minnesota where Raw Bistro is headquartered. I visited their 140-acre turkey farm and met the turkeys. I went to Thousand Hills Cattle Company and saw cows grazing on a hill.
The entire group at Raw Bistro was very interested in showing me exactly where the animals came from, the ethical way they are raised, the ethical slaughter process, as well as their safe handling techniques for producing great farm-to-table, human-grade, organic pet food. I fell in love with the company because of everything they stand for and the products they create.
Raw Bistro Uses Phage Technology
I wanted to talk to Justin today because Raw Bistro's also doing something very different from the traditional option of HPP for managing pathogenic bacteria. I asked him to talk a little about it.
“We looked at some of the different options out there, HPP was one of them, and phage technology was another,” explains Justin. “We just felt that phages were the least invasive process to control pathogenic bacteria, meaning salmonella, E. coli, and listeria, without affecting any of the beneficial microbes in the foods.”
Raw Bistro partnered with Sandro’s company, Intralytix.
“We brought in some sample kits,” says Justin. “It's something that we've been working on for the last 18 months or so, and doing small sample batches and testing the product to see the efficacy of the phages. Over time, we built our processes within our plant to make it the most effective that we can.
We make a small batch with phages, without phages, and we're testing and sending in tests to a lab to test for salmonella, E. coli or listeria, and looking at those test results. We’re seeing around 98 percent control of pathogenic bacteria.”
That’s an excellent result — it’s actually about as good as it gets using a natural control option. I asked Justin if Raw Bistro made a conscious decision to avoid HPP.
“We did,” he replied. “We never wanted to do HPP. We know food has tons of microbes within it, and really the only thing we're trying to prevent is salmonella, E. coli and listeria — the disease-causing bacteria. But there are many other beneficial microbes within the food that we definitely don't want to destroy. HPP doesn't differentiate between good and bad bacteria.”
I really appreciate that Justin and Raw Bistro have focused on finding an innovative way to control pathogens without having to sterilize the wonderful food they produce. I’m also very grateful for the company’s transparency. It sets a great example for the pet food industry as a whole.
In fact, they’re about to host a group of retailers for a tour. I'm proud of them for leading the way in both transparency and innovation. Next week, I’ll be talking to Answers Pet Food, who has taken a slightly different approach to managing bacteria in their food. Stay tuned!