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With a focus on inhalation toxicology and pre-clinical testing and research for some of the world’s most critical needs, Amplifybio provides expertly-crafted solutions to public and private sector clients. We serve these entities with years of experience creating comprehensive study design methods and have the ability to complete whole-body inhalation testing on multiple species. Our solutions are developed by inhalation toxicologists, technologists, and other experts who leverage state-of-the-art laboratories and equipment to complete specialized toxicity testing, acute inhalation research, and more.
Standard and customized support is a necessity to treat disease or sickness in the airways of the body. Inhalation pharmaceuticals are developed and instituted to solve those challenges.
Amplifybio leverages decades of expertise in inhalation toxicology studies for pharmaceutical and medication development partners, aerosol safety testing & vapor solutions, industry-leading acute to chronic exposure systems, and many other standard respiratory therapies for humans and animals. We produce an ever-expanding list of inhalation toxicology service capabilities, including:
Through our internal efforts and through a longstanding partnership with Battelle, Amplifybio has curated a number of thought leadership resources for inhalation toxicology and many other globally utilized services.
Preclinical CRO services play a crucial role in drug development by conducting studies and experiments on potential therapeutics before they advance to clinical trials. AmplifyBio offers a wide-range of preclinical CRO services including:
As an expert contract research organization (CRO), AmplifyBio leverages decades of experience to create modern commercial drug development solutions. From CRO and preclinical CRO needs to cell and gene therapy and advanced therapy testing, our accredited team designs innovative paths to produce globally recognized studies, services, and more.
Inhalation toxicology is essential for studying the effects of inhaled drugs and chemicals on the body, and there is a growing need for studies involving difficult-to-generate test articles such as biologics. Precision in inhalation studies is in high demand to meet regulatory requirements, understand low-level exposures, and generate accurate safety and efficacy data. Poorly designed or executed studies can lead to inaccurate conclusions, which can have disastrous results when used to make decisions about drug dosages or exposure limits. AmplifyBio’s scientific team collaborates with clients to ensure studies are designed to meet scientific and regulatory needs.
The most commonly used methods to deliver the test atmosphere for inhalation testing are; nose-only inhalation, head-only inhalation, mask-only, and whole-body exposure. All methods at AmplifyBio may include real-time respiratory monitoring if the client desires. Clients always have access to our team of experts who custom design, test, and characterize novel inhalation delivery systems to enable controlled exposure concentrations and aerosol sizes for your study requirements.
To obtain defensible results from an inhalation study, researchers must first be able to generate an exposure atmosphere that meets the study requirements. This means having the right concentration of the test article at an appropriate particle size that will reach the lung alveoli. Additionally, also it must be verified that that the test article is distributed homogenously throughout the exposure environment, and that the environment is free of unintended contaminants.
It depends on the goals of the individual project or program. If the study is intended for product submission or registration, it is critical to ensure that it meets the requirements of the applicable regulatory agency or agencies (FDA, EPA, other country). At the same time, companies don’t want to drive up study costs by scaling the study beyond what it needed or conducting a Good Laboratory Practice (GLP)-compliant study if it is not required.
Process controls and environmental controls must also be in place to ensure repeatability between trials; between individual studies for compounds required multiple studies and between studies days for multiple dose day studies. Maintaining consistent temperature, pressure, and humidity within the exposure environment is essential. Changes in model loading methods and the ambient environment can also impact the study’s results. Maintaining the necessary levels of consistency can be challenging, especially for 24/7, whole-body exposure dose studies. Here at AmplifyBio, we have the ability and controls to mitigate these issues.
In inhalation toxicology, accurately assessing the inhaled dose and particle deposition within the respiratory tract are key challenges. Assumed respiratory parameters may lead to inaccurate estimates of inhaled doses, resulting in erroneous conclusions about the effects on the body. Particle size affects deposition location, impacting the bioavailability and toxicity of the test article. AmplifyBio’s inhalation team has extensive experience generating and controlling test atmospheres and interpreting data to address these challenges.
The species of animal commonly used is often dictated by the animal model(s) of disease available for efficacy studies and toxicology studies. The common animals used are rodents (mice and rats), beagle dogs, and nonhuman primates (Cynomolgus and Rhesus macaque). However, other animal types used can be hamsters, ferrets, rabbits, and swine. These animal types are purpose-bred for scientific studies from vendors accredited by the USDA to supply the animals to facilities (contract research organizations, universities etc.) that use animals for scientific testing. The Inhalation team at AmplifyBio has experience in inhalation testing with all animal types.
