A Milestone in Infant Health: Celebrating Lot 8 of BabyBIG®

On October 2, Heluna Health was thrilled to join the celebration of Lot 8 of BabyBIG®, the life-saving treatment for infant botulism, at Takeda’s Los Angeles manufacturing site. Members of our team joined colleagues from Heluna Health partner, the Infant Botulism Treatment and Prevention Program (IBTPP), along with Takeda leadership and staff, and the BabyBIG® production team for a memorable morning honoring this important milestone.

Infant botulism was first discovered in 1976, and after many years of development and clinical trials, BabyBIG® was approved as a treatment by the FDA in 2003. Produced only once about every five years, it is the result of years of dedication, scientific excellence, and community partnership, all united to protect the most vulnerable among us. Each lot, like the one highlighted on this day of celebration, consists of plasma generously donated by adult volunteers that is then processed in the lab to create the drug. BabyBIG® remains the only FDA approved drug for the treatment of infant botulism and has treated 3,795 patients in the U.S. and internationally. 

The Infant Botulism Treatment and Prevention Program (IBTPP), part of the California Department of Public Health and partner of Heluna Health since 1998, plays a vital role in this effort. The team provides treatment and consultation for suspected cases, testing and epidemiology, and leads research and education to improve the study, prevention, and treatment of infant botulism. IBTPP also works closely with physicians, communities, and families, offering expert guidance and support. 

During the event, guests enjoyed an immersive virtual reality tour of the BabyBIG® lab and an interactive demonstration highlighting the augmented reality (AR) technology that supports the drug manufacturing process. Additionally, attendees had the opportunity to tour the site’s quality control lab, seeing firsthand the meticulous work that ensures all products meet the highest safety and efficacy standards. 

The celebration continued with remarks from Takeda leadership and IBTPP staff, along with plasma donor, Jason, and included special recognition of Sage, a survivor of infant botulism thanks to BabyBIG®. Her grandfather shared meaningful remarks about the importance of the BabyBIG® team and all those involved in getting the drug to patients who need it. 

The event concluded with the highly anticipated arrival of the truck carrying the plasma to be used for this batch of BabyBIG®, complete with a police escort to ensure its safe travels. There were smiles and cheers all around as the team and honored guests posed for pictures in front of the truck to capture the momentous occasion. 

Heluna Health is proud to support this lifesaving work through our partnership with IBTPP. Each new lot of BabyBIG® tells a story of hope, partnership, and our shared commitment to keeping children safe and healthy. 

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