In what’s been a major breakthrough, BabyBIG, the human botulism immune globulin derived from donor plasma, has saved babies from infant botulism linked to ByHeart formula as the outbreak has affected at least 39 infants across 18 states since August.

The treatment relies on antibodies donated by volunteers and was developed by the late Dr. Stephen Arnon and his team, with pivotal clinical trials in 1997 showing shorter hospital stays and reduced need for ventilation.

California officials say they have enough BabyBIG in reserve to cover the outbreak through next summer, underscoring ongoing demand for the therapy.

The BabyBIG program faced funding and resource hurdles because infant botulism is rare, with fewer than 200 U.S. cases per year, and the project required roughly 15 years and about $10.6 million to bring it to production.

Overall development extended over about 15 years and cost around $10.6 million, reflecting the significant funding challenges tied to a rare disease.

These challenges included a lengthy fundraising process and the rarity of infant botulism, which complicated early support for research and production.

Families of recovered children have expressed deep gratitude, while donors like Shine find personal meaning in contributing to a life-saving product.

Letters and photos from families of recovering infants highlight the tangible impact of BabyBIG on lives saved.

Donors describe a strong sense of purpose, with testimonials about helping save lives and maintaining connections with families through ongoing updates.

Each BabyBIG batch costs nearly $70,000 and is produced by Takeda on a not-for-profit basis, with proceeds funding the botulism program; Batch 8 is currently in development near Los Angeles.

The program depends on about 30 donors per batch, with development and recruitment spanning nearly 15 years and $10.6 million, reflecting rarity and funding hurdles.

California funds and contracts Takeda to produce BabyBIG on a not-for-profit basis, while the supply chain remains limited due to the rarity of infant botulism and fewer than 200 U.S. cases annually.

Donors like Nancy Shine contributed plasma after vaccination against botulism, providing antibodies that form BabyBIG’s core, with donors undergoing plasma-harvesting procedures and ongoing studies.

Approximately 30 donors contribute plasma per batch, and new donors must join a clinical study and receive booster doses of an investigational botulism vaccine.

Older donors have aged out, necessitating ongoing recruitment of new donors who participate in studies and receive boosters for the investigational vaccine.

Infant botulism affects babies under one year old when they ingest spores; the resulting toxin targets the nervous system and can require extended hospital care.