Cellular agriculture, which uses biotechnology to produce agricultural products from cell cultures, has expanded its focus from cultivated meat to human nutrition. North Carolina-based company Biomilq is pioneering this application by developing a product that replicates human milk outside the body. This involves cultivating human mammary cells in a controlled laboratory environment to produce a liquid intended for infant consumption. This technology aims to offer a new feeding alternative that combines the nutritional complexity of human milk with the practical advantages of traditional formula. Examining this process provides insight into the biotechnology and significant regulatory challenges involved in bringing such a novel food to the consumer market.
Defining Cultured Human Milk
Cultured human milk, as envisioned by Biomilq, is a product biologically synthesized by human mammary epithelial cells grown in a lab setting. The core mission is to create a nutritionally complex infant feeding option that is closer to human milk than existing cow’s milk or soy-based formulas. This product is not intended to replace breastfeeding, which remains the recommended source of infant nutrition. Instead, it is designed to serve as a supplemental or primary source for parents who cannot, or choose not to, breastfeed.
Standard infant formulas, typically derived from bovine sources, often lack nutritional certainty. Culturing milk components directly from human cells ensures the resulting product contains species-specific proteins and fats suitable for human infants. This offers a potential alternative for families who rely on formula but want a product with a more appropriate biological composition. The goal is to empower parents with a feeding choice that moves beyond the limitations of current formula options without requiring traditional lactation.
The Cell Culture Process
The production of Biomilq begins with obtaining human mammary cells, which are typically sourced from donated milk or tissue. These cells are isolated and established into stable cell lines that can proliferate indefinitely in a laboratory setting. This initial phase focuses on nurturing the cells to ensure they are healthy and capable of milk production. Nutrient-rich media is used to feed the cells and promote growth.
Once established, the cells are transferred into a proprietary bioreactor system for milk secretion. The bioreactor mimics the physical and biochemical signals that occur during lactation. This includes supplying specific hormones, such as prolactin, which trigger the cells to differentiate and begin producing milk components.
The cells are often grown in a monolayer arrangement, allowing them to absorb nutrients and secrete the resulting milk product. This compartmentalization is a key engineering challenge, as it separates the final milk product from the nutrient medium. By providing the necessary biological signals and a controlled environment, the cells secrete a complex fluid containing proteins, sugars, and fats directly into the collection chamber. This process allows for the creation of a whole milk product without extensive downstream purification steps.
Nutritional Profile and Composition
The composition of Biomilq is designed to replicate the complex nutritional profile of human milk, which differs structurally from bovine-based formulas. The product contains macronutrient profiles that closely match the proportions of proteins, complex carbohydrates, and fatty acids found in human milk. The cells produce human-specific proteins like casein and lactose, the foundational components of milk.
A significant advantage over traditional infant formula is the presence of bioactive components, such as human milk oligosaccharides (HMOs) and polyunsaturated fatty acids (PUFAs). HMOs are complex sugars that act as prebiotics, supporting a healthy gut microbiome. Cultured milk also contains anti-inflammatory PUFAs, which support neurological development, unlike many formulas where these components are added in isolated forms.
However, the product is not bio-identical to mother’s milk, as it cannot fully replicate the dynamic, real-time biological interactions of a lactating parent. For example, the cultured milk is unlikely to contain the full suite of immunoglobulins and other immune factors transferred directly from the parent’s bloodstream. While it exceeds the complexity of conventional formula by producing bioactive lipids and numerous HMOs, it does not display the moment-to-moment compositional changes that occur during natural feeding.
Regulatory Pathway and Market Status
For a novel food product like Biomilq to be sold in the United States, it must undergo a rigorous safety assessment by the Food and Drug Administration (FDA). The most likely path is the Generally Recognized as Safe (GRAS) process, requiring scientific data to demonstrate the substance is safe for its intended use. This process involves submitting extensive data on the product’s composition, manufacturing process, and toxicological profile.
The regulatory path for a product made from cultured human cells presents unique challenges, as the FDA must determine how to categorize it—either as infant nutrition or a dairy product. Any company creating a new infant formula must also comply with the Federal Food, Drug, and Cosmetic Act, which mandates specific nutritional and safety standards. Comprehensive safety and efficacy testing requires significant time and capital investment before market entry.
Despite early success and substantial funding, the path to market for Biomilq was cut short. The company faced a protracted intellectual property dispute that ultimately made it impossible to secure further investment or acquisition. In late 2024, the company filed for Chapter 7 bankruptcy protection, signaling the closure of operations. This legal hurdle prevented the product from advancing through safety assessment and scaling, leaving the technology’s future uncertain and the cultured milk product unavailable for consumer distribution.