If you were reasonably sure you could get a similar therapeutic benefit from a food as from a prescription drug, which would you choose? Let’s say you had a gastrointestinal problem. Would you rather take a drug like Lomotil, or would you go for the yogurt with probiotics? If you’re like most consumers these days, you’d be reaching for the yogurt, according to a recent survey. Consumers are increasingly looking for alternatives to pills. They spent $75.9 billion on Pharma foods that have medicinal properties—in 2018.
But are these so-called functional foods safe to eat? Prescription drugs are made under GMP conditions, assuring their quality and safety. They’re subjected to microbiological testing to make sure bacteria and toxins are within specified levels set by regulatory bodies. This is particularly true for injectable drugs, but also for pills and topical drugs. But foods? We hear all the time about E.coli and salmonella outbreaks that cause food manufacturers to recall foods from grocery shelves.
This article will delve into the making of pharma foods, which are expected to provide a combination of nutrition and therapeutic value, and why GMP production is a growing opportunity for innovative companies seeking to benefit from the convergence of food and pharmaceuticals.
Pharmaceutical-grade foods
That consumers are demanding healthier foods is nothing new. The adage, “an apple a day keeps the doctor away” first appeared in the 1920s. These days not only apples but supplements and nutraceuticals such as protein powders, vitamins and fish oil, to name a few, consume entire sections in stores, whether their consumption is backed by clinical data or not. As people live longer lives, and as the media makes us constantly aware of health concerns, many want to do what they can to live not only long lives, but also healthy lives.
Enter pharma foods, a relatively new frontier that goes beyond nutraceuticals to encompass functional foods that can’t be purchased in a supermarket — they require a prescription. For example, one of our customers, in doing clinical research, found that hypertriglyceridemia, a disorder characterized by abnormally high triglycerides, was related to certain lipid imbalances that diet alone couldn’t remedy. The company saw an opportunity to develop nutritional-based products to treat the condition. Their products contain an active pharmaceutical ingredient and hence must be prescribed.
Like drugs, medical foods are regulated by the U.S. FDA. Not only must pharma foods comply with all FDA requirements for foods, but to be considered a pharma food they must use ingredients recognized as safe. They must be developed using established scientific principles and manufactured under GMP.
What manufacturing pharma foods under GMP entails
To assure the pharma foods we are developing meet regulatory tolerance for such microbials as pathogenic bacteria, viruses and parasites, swabs are taken from sample batches, placed on petri dishes and incubated.
Concerns about these potentially toxic microbials are reduced when organic solvents are used in producing compounds—microbials generally can’t survive in organic solvents. However, if water is used, the opportunity for bacterial contamination increases. Consequently, in our GMP suites we use high purity water both for processes and, along with solvents, for cleaning our equipment.
Licensure required
In Massachusetts, where our plants are located, licensure is required to manufacture pharma foods, despite the fact that we have for decades been manufacturing drugs under GMP. To be licensed we were required to retrofit our plants with extra sinks for the added handwashing protocols. We also installed special racks for hoses to make sure they never touched the floor or another piece of equipment. Another requirement: specific employee training.
Diverse pharma food projects
Pharma foods are diverse and encompass anything that will be ingested by humans – and pets. They include:
- Prescribed foods containing APIs.
- Spray coatings for fruits and vegetables that increases their shelf life.
- Products that straddle the line between nutraceuticals, supplements and food products.
Generally, outsourced pharma food projects have these common characteristics:
- The products require multi-step organic synthesis.
- They are produced in significant volumes, from hundreds of Kg to multi tons.
- They need to be produced in a GMP facility.
- They require a state licensed facility to do the manufacturing.
- They have analytical and documentation requirements similar to those for drug candidates.
- They must adhere to strict specifications.
Cost is a challenge
Although manufactured with the same intensity as a drug product, something consumed as a food or included in a food on a per Kg basis does not command the higher price consumers are accustomed to or willing to pay for drugs. It makes the cost of goods (COG) for pharma foods higher and margins smaller.
Still, nutrition-based therapies are growing in popularity, particularly among many who view them as a more natural alternative to drugs. Seeing the potential, large companies such as Nestle and Abbot Labs are jumping in, as are smaller companies. For example, Nestle produces SMA® Altéra®, an extensively hydrolyzed hypoallergenic infant formula for babies with cow milk protein allergies, while Abbot’s Nutrition division develops and markets functional foods for all age groups, from the very young to the very old.
Consumers want safety too
At the end of the day, discerning consumers are apparently willing to pay more for pharma foods due not only for their perceived therapeutic benefit, but also the greater safety afforded by the strict antimicrobial specifications and quality control that licensed GMP facilities creating them adhere to.
There’s a lot of consumer interest in functional foods (aka nutraceuticals), and we’ve seen continuing demand for this expertise. We’ve worked on many projects, and one thing we’ve seen is that pharma food companies work with us because of our cGMP manufacturing expertise but they need more than that. They also want a partner who can work with them on their own terms. As with all our clients, we make sure to understand your goals, which helps us make better recommendations to our sponsors about how to proceed.
If you’d like to talk about your needs and to ask us about our approach and expertise, please call us at (978) 462-5555 or email us at info@pcisynthesis.com.