Australian start-up All G receives go-ahead to sell animal-free milk product in US

Australian health tech company All G has “self-affirmed” approval for its recombinant bovine Lactoferrin, opening the door to US market entry.

The company, which specializes in producing bovine and human identical milk proteins using precision fermentation, says it has achieved self-affirmed Self-GRAS (Generally Recognized As Safe) status for its product.

GRAS self-affirmation allows a company to determine whether, based on scientific evidence, a substance is safe for its intended use in F&B and does not require pre-market approval from the US Food and Drug Administration (USDA).

All G says it followed “rigorous internal testing and evaluation by external experts” to ensure its recombinant bovine Lactoferrin aligns with FDA standards for safety and efficacy for adult nutrition. It hopes the milestone will open up GRAS submission to the USDA in 2025.

The start-up aims to shake up the dairy industry by offering a new, less laborious way of producing its milk alternative, bioequivalent Lactoferrin. 

Disrupting the dairy market

Lactoferrin is a multifunctional protein naturally present in milk. It is known for supporting immunity, iron regulation and gut health, among other benefits. According to the company, producing just one kilogram of purified Lactoferrin requires processing approximately 10,000 liters of cow’s milk, leading to market prices ranging in the hundreds of dollars per kilogram. 

All G wants to upend this resource-intensive process, which limits accessibility and confines its use to select products like infant formula, says the company.

It also claims to produce bioequivalent Lactoferrin at a significantly lower cost and without reliance on cows while delivering more than 98% purity and equivalent bioactivity to animal-based Lactoferrin.

“Our proprietary strain is a breakthrough in Lactoferrin production,” says All G founder and CEO Jan Pacas. “We can now engage with US F&B companies to bring a stable supply of an affordable, high-purity protein that can either be substituted into existing production processes or used to open up new markets.”

Chief scientific officer Jared Raynes highlights the extent of technical challenges that must be overcome in Lactoferrin production.

“Precision fermented Lactoferrin needs to exhibit high purity and bioactivity, equivalent iron saturation status, and have native-like glycosylation patterns to be considered bioequivalent,” he notes.

“We have managed to meet these stringent requirements through our deep R&D expertise.”

The company is also working on approvals for infant formula, which requires additional regulatory steps. It says that Lactoferrin-enriched infant formula has the potential to bring formula-fed infants closer to the nutritional profile of human milk, addressing a gap in the market.

Last month, the start-up received regulatory approval to sell its bovine Lactoferrin in China.