Emergent Biosolutions, Inc.

Emergent BioSolutions develops and manufactures medical countermeasures for public health threats, including vaccines and therapeutics for anthrax, smallpox, and botulism. Its product development pipeline relies on animal testing to meet regulatory requirements, particularly under the FDA's "Animal Rule," which permits approval of certain drugs based on efficacy studies in animals when human trials are not ethical or feasible. The company's 10-K filings explicitly cite laboratory and preclinical tests, including animal testing, as part of its standard development process. Published research, such as a 2021 toxicity study for its AV7909 anthrax vaccine conducted in Sprague Dawley rats, further documents this practice.

The company's reliance on animal models is central to its business. Emergent notes in its regulatory filings that assessments of its products depend on the sufficiency of animal data. This is evidenced in studies of its heptavalent botulinum antitoxin, where animal models are used for functional detection of neurotoxins. While much of this testing is a regulatory requirement for biodefense products, Emergent BioSolutions commissions, funds, and conducts these animal studies as an integral part of its operations.