Case Studies

Battelle was selected to support both nonclinical and clinical programs to help determine the effectiveness of candidate countermeasures for Sudan and Marburg viruses.

The current lack of licensed countermeasures for alphaviruses is a challenge, necessitating the development of effective vaccines and therapeutics.

The high-profile Zika virus outbreak in 2016 proved that the disease causes serious birth defects in humans and highlighted a need for vaccines and treatments. Battelle was chosen to pursue development of assays, evaluate the immune response, and evaluate efficacy and immunogenicity of multiple Zika vaccine and therapeutic candidates.

The 2014 Ebola epidemic prompted an urgent need for an approved vaccine to treat or prevent the disease in future outbreaks. Based on Battelle’s extensive experience in vaccine testing and managing highly regulated, complex projects involving high-containment pathogens, we were chosen to evaluate the immunogenicity and efficacy of Ebola vaccine candidates to determine if they were protective.

Read on how Battelle was tasked with performing preclinical safety studies to determine cause of toxicity in preclinical models of a nerve agent antidote for the DOD.

We're improving the quality of life for the 5.3 million Americans who suffer from an ABI with our innovative biofeedback device.

A medical device manufacturer released a medical instrument that combined glass and plastic components. The plastic component was made of polyether ether ketone (PEEK), which was joined to the glass component using a cured epoxy. Through Battelle’s Surface Science program we identified an atmospheric plasma treatment as an approach to solve the adhesion problem and avoid changes to the product design or manufacturing process

A pharmaceutical company was evaluating potential options for a combination drug and injection device for a highly viscous drug. The viscosity of the drug made it difficult to inject by hand. To improve safety and reduce hand fatigue, they needed to modify the flanges or thumb pad on the syringe. There were custom-made and commercial-off-the-shelf (COTS) options available. Our client came to Battelle for help in deciding which one modification option would be most likely to be accepted by their end users.

A sponsor organization developed a novel oncolytic viral therapeutic of genetically engineered herpes simplex virus type 1 (HSV-1) targeted to treat glioblastoma. Battelle was contracted to complete a GLP, IND-enabling study, evaluating the toxicity, biodistribution and efficacy of the therapeutic in a human orthotopic xenograft model.

A medical device manufacturer was experiencing an intermittent problem with an injection-molded plastic component. During startup, parts would come off the line with a small blister in the plastic. They came to Battelle for help in solving the mystery.

Environmental chemicals that may disrupt the hormonal or endocrine systems of humans as well as wildlife and other animals have been a concern since at least the 1960s. Many of the endocrine screening assays and other tests in use today are based on or supported by research that was led by Battelle.

Prestige Brands, the parent company behind the Efferdent™ brand of dental appliance cleaners, wanted to extend their market opportunities by offering consumers a new on-the-go option for cleaning dentures, retainers, clear braces, and mouth guards. Prestige Brands asked Battelle to develop and test a cleaning formulation that could be impregnated into a disposable, textured wipe.

Although lead exposure among U.S. children is declining, significant exposure and subsequent effects remain and harm children disproportionately in certain communities. To address this challenge, Battelle developed a blood-lead prediction model that is applicable at the census tract level across the U.S. The model relies upon predictors available nationwide and can be applied to provide useful, population-level estimates of BLL in areas without available surveillance data.

Each year, MD+DI invites innovators, entrepreneurs, students and the broader healthcare community to submit ideas for the medical device of their dreams. The “Dare to Dream” contest asks entrants to envision a new medical device uninhibited by financial or regulatory concerns. The goal is to spur bold, innovative ideas that will push the industry to rethink what is possible in the medical device realm. Entries are judged on creativity and design, market viability and their potential impact on healthcare.

The Family Smoking Prevention and Tobacco Control Act requires premarket approval of all new tobacco products commercially marketed after Feb. 15, 2007—unless they are shown to be “substantially equivalent” to an existing tobacco product. Battelle conducted internal research to validate analytical methods to be used for characterization of tobacco products for purposes of demonstrating Substantial Equivalence.

Little cigars have been rapidly growing in popularity, especially among younger smokers. However, their chemical composition has not been as well characterized as the composition of traditional cigarettes. Battelle researchers studied four popular little cigar products against four popular cigarette products in order to determine the new and distinctive exposures associated with little

Our client needed a comparative formative study of two different devices for administration of glucagon in rescue situations (i.e., diabetic severely hypoglycemic and going into shock). It was critical to determine how well users were able to use the devices when under extreme stress and develop risk/safety profiles for each device.

The CDC came to Battelle in 2008 for help in managing, implementing and improving the National Environmental Public Health Tracking Network, an online portal for environmental and public health data reporting, collection and dissemination.

Battelle supported the SERVIR program, a joint effort by NASA and the U.S. Agency for International Development (USAID), by creating science applications for international development through the use of Earth observations. Focusing on air quality and health, this project involved a series of specific tasks related to air quality monitoring, analysis, forecasting and visualization for Latin America.

Battelle is working alongside the U.S. Environmental Protection Agency's (EPA) Office of International and Tribal Affairs to provide capacity building to Central American countries, including Ministries of Environment and Health, academic institutions, and the private and non-profit sectors to improve their management of air quality.