Precision fermentation may be poised to disrupt key agri-food markets, extending successes in high-end uses for human medicine, by using microbes to create animal-free proteins, where precision fermented (PF) milk has the largest near-term potential.

New Food Finance data show that PF milk protein companies have raised $1.8 billion cumulatively to date, with 2024 so far double last year, a significant achievement in the present market.

Precision fermentation involves introducing a specific gene from one organism into a microbe that can then produce the coded protein. The process has been used in medicine for many years to produce essential drugs like insulin: the gene for insulin is taken from humans, and inserted into yeast, which is then fermented to mass produce an exact replica of human insulin, for type 1 diabetics.

In the case of conventional milk, there are three key proteins, each with their own uses, which PF start-ups are aiming to disrupt:

Whey makes up about 20% of milk proteins.

• It can be used as a protein supplement, and is added to foods to boost their nutritional profile. Whey is a complete protein, containing all nine essential amino acids, and is very bioavailable, meaning it is quick to digest and absorb.

• One company producing PF whey protein is Perfect Day.

• Some PF whey protein products are becoming available, in time-limited trials. Nestle brand, Orgain, states that its PF whey powder has now been discontinued, but was retailing at $2.25 per ounce ($7.95 per 100 grams). A random internet search indicates whey isolate from conventional dairy retails at around $2.50 to $4 per 100 grams.

Casein accounts for about 80% of cow’s milk proteins.

• Casein forms micelles, which give milk its white colour. It is an emulsifier, enabling oils and fats to mix in water in milk. It is used in cheese spreads, and is the protein that gives vegan cheese its stretchy texture and melt.

• New Culture produces PF casein to create vegan cheese with an authentic taste and texture. The company says its cheese is not yet available for sale.

Lactoferrin is found in cow’s milk, but in much higher quantities in human milk.

• Lactoferrin is part of the whey protein family. It is a key ingredient in human baby formula, as it supports the baby’s immune system, and improves gut health. Lactoferrin is only found in very small amounts in cow’s milk, making extraction expensive and limited.

• Harmony Baby Nutrition produces human lactoferrin using precision fermentation. Another company, Helaina, recently raised $45 million to launch a baby formula.

PF proteins often require regulatory approval, because their production process is classed as novel, using genetically modified microbes, with no history of consumption prior to the benchmark year of 1997, according to the definition of “novel food” in Britain and the European Union.

Following is a summary of the state of play, in selected countries:

• The U.S. FDA (Food and Drug Administration) has granted GRAS (generally recognized as safe) status to companies like Perfect Day. Individual companies apply for GRAS status, with approval relating to the specific product.

• In the European Union, products must undergo a detailed safety assessment under the Novel Food Regulation, and the EFSA (European Food Safety Authority). To date, only two companies have submitted applications for PF dairy proteins, Perfect Day and Remilk, both awaiting final approval.

• Australia and New Zealand are in the process of reviewing similar applications through FSANZ (Food Standards Australia New Zealand).

• In India, the government has started framing regulatory guidelines for alternative protein. The FSSAI (Food Safety and StandardsAuthority of India) has granted pre-market approvals to certain companies, including Perfect Day, for mycoprotein and precision fermentation-derived non-animal whey protein.  

• Singapore has proven a leader in approving novel food technologies, for example approving TurtleTree’s precision fermentation-derived lactoferrin.