How Takeda manufactures BabyBIG with plasma from 30 donors and California Highway Patrol escort

Boston Business Journal

By Hannah Bartham-Green

January 27, 2026

Takeda's Los Angeles site typically operates 24/7, 365 days a year, producing plasma-derived products.

But once every five years, work in one building stops. All 23 pieces of manufacturing equipment are removed from the production floor, and the team brings in 45 pieces of equipment dedicated to the production of an antitoxin named BabyBIG, said Babak Haghiri, Takeda’s Los Angeles site head.

Public health workers, pharma employees and donors are among those who come together to make BabyBIG, a treatment for the very rare instance when a baby falls ill with infant botulism. And while it's still rare for infants to contract botulism, outbreaks can quickly drive up the number of patients needing immediate treatment. The latest outbreak began in November 2025 and was tied to ByHeart formula. It sickened 51 babies, according to CDC data, including two in Massachusetts.

Left untreated, infant botulism can cause paralysis in infants under 1 year old, and it can ultimately be fatal. The only effective treatment for infant botulism is BabyBIG, which is produced by Takeda Pharmaceuticals on a not-for-profit basis through a partnership with the California Department of Public Health.  

Takeda (NYSE: TAK), which has its U.S. operations based in Cambridge, first got involved in BabyBIG in 2007 and produced its latest batch in 2025. The Japanese pharma giant let the Business Journal look under the hood of this partnership to see how it produces the only FDA-approved infant botulism treatment.

How BabyBIG is made

The late Dr. Stephen Arnon led the creation of BabyBIG, which was approved by the FDA in 2003. Arnon spent time in Massachusetts earning his bachelor’s, MPH and MD from Harvard.

Infant botulism is so rare that BabyBIG is only made once every five years on Takeda’s 11-acre site in Los Angeles. In preparation, Takeda will stockpile the commercial plasma-derived products it usually uses this manufacturing floor to make. Plasma, or the liquid part of blood, contains proteins and antibodies that can be used to make medicines.

The plasma needed to produce BabyBIG is so precious, it arrives at Takeda’s LA site with a California Highway Patrol escort. The plasma comes from a small pool of people — about 30 donors — who are already immunized against botulism.

“The entire site comes out. We accept that plasma with open arms. And it's a special day because our employees, they understand the impact that they have in saving the infants,” Haghiri said. 

In 2025, 77 workers were involved in the production of BabyBIG. Over 1,000 employees work at Takeda’s LA site. 

Haghiri said the BabyBIG equipment is run through tests to make sure it meets the requirement for manufacturing, and employees also go through training. 

“You could imagine that we only have one shot to get it right every five years, so we cannot make any mistakes,” Haghiri said. 

After the manufacturing process is done, Takeda ships off the product to a filling facility where it is put into vials, and then sent to the California Department of Public Health for distribution, Haghiri said. Takeda’s role in this whole process takes about four to six months.

Takeda has an expertise in plasma-derived therapies that extends beyond BabyBIG. 

Giles Platford, president of Takeda’s plasma-derived therapies business unit, said the company collects roughly 17 million liters of plasma a year that they then process in one of eight manufacturing sites to make treatments for rare and complex chronic diseases.

But making BabyBIG on a non-profit basis is special for many Takeda employees, because otherwise patients would not have a treatment option. 

“When it's an ultra rare condition like this one, it's hard to make that a commercially viable opportunity for any company to pursue,” Platford said. “The cost of sourcing that plasma, shutting down the lines, producing it, and then obviously making it available for such a small group of patients…probably the only way to do that is kind of thinking purely about the patients that are in need.”

All 51 of the babies sickened in the 2025 outbreak were treated with BabyBIG, according to the CDC. All of them survived.

(Orignial article here.)