It Takes a Village to Make BIOMILQ:Ethics and the cells used to make cultured human milk

Community in motherhood and parenting has sustained our society since humans first evolved; however, a recent study found that 51% of new mothers feel lonely (1). Parenting was never meant to be done in isolation. In fact, anthropologists believe that from our earliest pre-historic times, children were raised under the framework of cooperative breeding, where nonparents helped groom, protect, and feed young children (2,3). In other words, it really does take a village.

BIOMILQ recognizes and values the importance of community in parenting. We seek to contribute to the parenting community by offering an alternative choice for infant nutrition. Uniquely, we also rely on a community of women who donate the cells that will ultimately produce human milk outside of the body.

K-18 (green) is a marker for mammary epithelial cells, the milk-makers. The blue dots are the nuclei of the cells which have been stained green. Cells may differ in size during different stages of development.

In our early stages, BIOMILQ generated cultured human milk using cells that had been previously used in other research studies, but were never optimized for milk production. We are now excited to be accepting donations of cells from women who believe in our mission and want to help other babies and families. We are isolating cells from donated breastmilk and from breast tissue removed during elective breast reduction surgeries performed at Duke University Medical Center. We then screen, select, and optimize for the cells that will produce cultured human milk that most closely resembles milk made in the body.

The cells from breastmilk and breast tissue donated to BIOMILQ will not only be used to produce cultured human milk, but will also be used to further science’s understanding of lactation biology, with findings to be published in peer-reviewed journals.

Of course, there is a long history of using human cells in science (4), but this is the first time human cells will be used to generate a food product.

We are keenly aware of our responsibility leading this space and sensitive to the history of ethical concerns surrounding the collection and commercialization of human cells (5).

Therefore, BIOMILQ places special emphasis on the ethical considerations of our work and ensures strict compliance with federal regulations of biological specimen donation.

BIOMILQ has undergone Institutional Review Board (IRB) review of the protocols we use to engage women who wish to donate, ensuring compliance with ethical codes. First and foremost, every woman donating must give informed consent, meaning that every donation is given voluntarily with an understanding of how the donated breastmilk or breast tissue will be used. Our donor coordinator walks through this process with every individual to answer questions. Additionally, donations are anonymous and the identity of each donor remains confidential. And because BIOMILQ values equity in our sampling population, women who are currently donating will represent a diverse cross-section of our community, with plans to extend donations beyond our immediate geographical area in the future.

We are proud that BIOMILQ will offer another choice for infant nutrition to mothers and families.

We are ready, if needed, to be a part of the village that you use to raise your children.

But we recognize that making cultured human milk would be impossible without the community of women who are donating their cells. We take that relationship and responsibility seriously. We know that it not only takes a village to raise a child; it will take a village to make BIOMILQ.

References:

1. Weissbourd, R., Batanova, M., Lovison, V. & Torres, E. Loneliness in America: Loneliness in America How the Pandemic Has Deepened an Epidemic of Loneliness and What We Can Do About It Executive Summary. www.makingcaringcommon.org (2021).

2. van Schaik, C. P. & Burkart, J. M. Mind the Gap: Cooperative Breeding and the Evolution of Our Unique Features. in Mind the Gap (eds. Kappeler, P. M. & Silk, J.) (Springer Berlin Heidelberg, 2010). doi:10.1007/978–3–642–02725–3_22.

3. Kramer, K. L. Cooperative breeding and its significance to the demographic success of humans. Annual Review of Anthropology 39, 417–436 (2010).

4. Jedrzejczak-Silicka, M. History of Cell Culture. in New Insights into Cell Culture Technology (InTech, 2017). doi:10.5772/66905.

5. Beskow, L. M. Lessons from HeLa Cells: The Ethics and Policy of Biospecimens. Annual Review of Genomics and Human Genetics 17, 395–417 (2016).