Each year in the United States, more than 530,000 babies are born prior to full 37 weeks of gestation. One of the major problems associated with prematurity is the development of a condition known as necrotizing enterocolitis (NEC). In 50% of infants with NEC a large amount of damaged and dead intestine must be surgically removed, often resulting in death or lifelong health problems. A growing body of experimental and clinical evidence supports a conclusion that deficient quantities of epidermal growth factor (EGF) leads to the development of NEC. The EGF peptide appears to be fundamental for normal intestinal development and repair. Soy-milk containing engineered EGF may be a suitable therapy if given to premature infants to prevent NEC. Human mature EGF is 6 kDa protein with three intramolecular disulfide bonds. To produce EGF a synthetic codon-optimized gene was transferred to soybean by biolistic transformation. The resulting transgenic lines were regenerated into somatic embryos that were screened by PCR and the production of EGF assayed by ELISA. Crude extracts of somatic embryos producing EGF were assessed for bioactivity by induction of phosphorylation of the EGF receptor in HeLa cells that showed soy-produced EGF exhibited the same activity as authentic EGF. T0 transgenic EGF seeds have showed positive ELISA for EGF demonstrating the feasibility to produce a therapeutic soy-milk to mitigate the development of NEC by premature infants. The next stage of this project will test the efficacy of Soy/EGF in an animal model for short bowel syndrome.