All G Launches LFX, the First Commercially Available Apo-Lactoferrin

All G, a biotechnology company specializing in precision-fermented milk proteins, has launched LFX, the first commercially available apo-lactoferrin, in the U.S. market. The ingredient is GRAS, and FDA issued a “no questions” letter in response to the company’s GRAS notification regarding its use in adult nutrition.

Lactoferrin is a protein shown to support immunity, iron regulation, and gut health. The company reports that lactoferrin’s biological activity is strongly influenced by how much iron is saturating the protein’s binding sites.

LFX is manufactured with less than 5% iron saturation, well below the threshold defined as “apo-lactoferrin.” This form has been shown across peer-reviewed studies to exhibit stronger biological activity compared to partially saturated or holo-lactoferrin, the company reported.

Lactoferrin in human breast milk contains low iron, while most dairy-derived commercial lactoferrins available on the market contain abou 20% iron saturation after processing; heavily iron-loaded holo-lactoferrin can exceed 80% saturation.

LFX’s more open iron-binding capacity differentiates the ingredient. When iron saturation is low, empty iron-binding sites can bind excess free iron, regulating homeostasis and limiting iron available to harmful bacteria which can support gut and immune function and improve dietary iron absorption without the need to consume extra iron.

“Lactoferrin’s ability to regulate iron is what drives many of its most valuable benefits,” said Jared Raynes, PhD, chief scientific officer at All G. “When lactoferrin’s iron-binding sites are already occupied, functionality becomes lessened. We are changing that with LFX by making the iron-free apo form commercially available at scale for the first time.”

LFX is standardized to greater than 95% purity, with a scalable supply independent of dairy production. The ingredient is free from lactose, hormones, and animal-derived residues, and is consistent from batch to batch. Presently, the company is producing LFX at a scale of multiple metric tons per year to ensure secure supply, and is available immediately for manufacturers.

“Introducing LFX in the U.S. is an exciting milestone for All G,” said Isidoor Maljers, business development manager at All G. “There is tremendous interest from companies looking to formulate with the apo form of lactoferrin because it offers a level of scientific differentiation in mirroring the naturally low-iron form of lactoferrin.”