Inhalation studies are among the most challenging, nuanced, and complex areas of toxicology.
Whether you require data to move a new therapy through U.S. Food and Drug Administration (FDA) approval or need to quantify exposure risks for an industrial chemical, trust Battelle for accurate answers and expert problem solving. We bring together world-class laboratory facilities with leading experts in inhalation to design studies that quickly deliver end-to-end solutions for FDA approval in compliance with Good Laboratory Practice (GLP) and U.S. Environmental Protection Agency (EPA) regulations.
Battelle has over 35 years of experience with model-based inhalation exposures for the pharmaceutical industry and is leading the way in developing, characterizing and validating study methods that improve data quality and study efficiency.
Battelle has provided significant scientific contributions
to 14 of the last 17 FDA-approved inhalation drugs.
We have extensive experience with a broad range of small molecules, therapeutics and chemicals, including biologics, anesthetics, asthma therapies, antibiotics and antivirals and microorganisms (bacteria and viruses). Our staff includes inhalation experts in the generation and characterization of biological agents (bacteria, viruses, and toxins), chemical agents, cigarette smoke, electronic cigarette vapor and nanoparticles as well as subject matter experts in study management (study directors; general, neuro, developmental and reproductive toxicologists; and pathologists).
We offer a comprehensive suite of standard inhalation toxicology studies, as well as custom solutions to address unique problems. Our experts can design, characterize and test novel inhalation delivery systems, develop new methods of aerosolizing compounds, and determine precise dosing concentrations for your study requirements.
Our capabilities include:
- Nose-only inhalation
- Head-only inhalation
- Whole-body exposure
- Intranasal instillation
- Intratracheal instillation
Ancillary capabilities include:
Need fast, accurate answers?
- Cardiovascular and respiratory telemetry
- Neurobehavioral evaluation
- Drug abuse liability evaluation
- Chemical and biochemical analysis
- Pharmacokinetic/toxicokinetic evaluation
- Radiolabeling studies
Contact us today for a free assessment.
The precise delivery of test material to the respiratory tract requires a combination of purpose-built facilities, exposure systems, analytical techniques and scientific expertise in aerosol generation and characterization. A full offering of scientific resources in aerosol science is required to provide safety and efficacy data that meet stringent FDA guidelines.
Our facilities have the capacity to accommodate high volume inhalation studies with 23 rooms specified for inhalation exposure, and additional rooms capable of inhalation exposure made available as needed.
One specialized Battelle lab is designated for the use of radioactive materials. This lab can be used in a variety of other experiments with radioactive tracers, including iodination of proteins for inhalation and other procedures, novel protein labeling processes for ADME studies, labeling plasma cells and 14C-labeled materials delivered by inhalation.
Battelle also has advanced Biosafety Level 3 (BSL-3) containment labs. BSL-3 labs are required to conduct efficacy evaluations by pulmonary administration of infectious or bioterrorism agents including inhalation studies. The BSL-3 labs include one inhalation suite with two Biological Safety cabinets Class III (BSC3).
Test atmosphere generation systems have ranged from commercially available pharmaceutical nebulizers and generators to proprietary devices designed by Battelle to unique proprietary commercial devices and special devices for one-of-a-kind applications.
Battelle’s inhalation toxicology experts include nationally and internationally recognized experts in the generation and characterization of smoke, nanoparticles, and biological agents (bacteria, viruses, and toxins). Support staff and engineers are available within Battelle for the modification and automation of client-supplied proprietary devices as required for use in aerosol delivery systems. Our ability to characterize particle size distribution, aerosol concentration and pulmonary function during in vivo exposure enables accurate measurements of inhaled doses.
At Battelle, your study matters. Whether you’re trying to get a new therapeutic to market or quantify the risks of an industrial or agricultural chemical, we’ll put our world-class experts and facilities to work for you—from initial study design to regulatory support. Count on Battelle to solve your most challenging problems and give you the attention you deserve.