Whether you require data to get a new therapy through 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 study design to deliver end-to-end solutions for FDA approval in compliance with Good Laboratory Practice (GLP) and EPA regulations.
We have extensive experience with a broad range of small molecules, therapeutics and chemicals, including biologics, anesthetics, asthma therapies, antibiotics and antivirals and microorganisms. Our staff includes experts in the generation and characterization of biological agents (bacteria, viruses, and toxins), chemical agents, cigarette smoke, electronic cigarette vapor and nanoparticles.
We offer a comprehensive suite of standard inhalation toxicology studies, as well as custom solutions to address unique problems. Our experts can design, test and characterize 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
- Cardiovascular and respiratory telemetry
- Neurobehavioral evaluation
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Battelle uses a controlled ventilation process that allows precision dosing via the respiratory tract of the test subject. Through control of the tidal volume, aerosol particle size and inspiratory flow rates, the pattern of aerosol deposition in the lung can be altered and controlled to achieve modeling of a human clinical exposure process.
In addition, because of the control of the respiratory process, precise inhaled doses can be administered, reducing inter-model variability to a level approaching the variability found in IV infusion. The alteration of the deposition pattern from what is typically achieved during tidal breathing allows the use of test subjects to model effects of deposition patterns upon the pharmacokinetics and bioavailability of the test material. This capability is particularly useful in evaluating the potential pharmacokinetic profile of a test article that will be administered in man using a metered dose inhaler or dry powder inhaler or any deep breathing process. Altering the deposition pattern can identify regions of the lung that are more effective in the absorption of proteins and other pharmacologic agents.
Our facility has the capacity to accommodate high volume of inhalation studies with 12 rooms specified for inhalation exposure, and additional rooms capable of inhalation exposure made available as needed.
One lab, designated for the use of radioactive materials, can capture scintigraphic images of radio-labeled aerosols deposited in the lungs. By radio-labeling the test aerosol with an isotope that emits gamma photons (typically 99mTc), scintigraphic images of the lung can be collected immediately after inhalation exposure. 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 of 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.
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 staff includes internationally recognized experts in the generation and characterization of smoke and nanoparticles. 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.
Get objective, accurate answers to meet FDA safety testing requirements for your new drug or therapy. We can help you get through the regulatory process with confidence. Learn more.
Pharmacological Efficacy Testing
Determine the efficacy and dosing requirements for novel drugs and biologic therapies. We deliver end-to-end solutions for all required species to help you streamline your pre-clinical testing needs.
Quantify the exposure risks of a chemical with traditional inhalation or whole-body exposure testing. We can give you the data you need to set safe exposure limits, mitigate risks and meet EPA regulatory requirements.
When you come to Battelle, you’ll find world-class expertise and dedicated, state-of-the-art facilities with everything you need to complete your study, from initial study design to regulatory support. And if your study requires an approach beyond the ordinary, don’t worry. At Battelle, we don’t just collect data – we solve problems.