AmplifyBio’s safety, efficacy, and toxicology unit (ASET) was launched as a preclinical CRO that spun out of Battelle 2021 to be commercially focused and meet the needs of modern drug development with speed and agility. AmplifyBio brings decades of experience to accommodate a wide variety of GLP and non-GLP studies in all species and dose routes. Among the investments that AmplifyBio has made to empower preclinical assessments is building a new state-of-the-art analytical laboratory to include molecular and immunological assays that assess critical safety and efficacy indicators for cell and gene therapies during in vivo studies. Additional investments in digital pathology, capacity optimization, and real-time data solutions ensure that AmplifyBio is the most responsive, collaborative, problem-solving partner in the preclinical CRO marketplace. Clients have direct access to our experts throughout the study, including the Study Director, dedicated Program Manager, and Business Account Manager, allowing for consistent communication and nimble decision-making. AmplifyBio is aware of how critical timelines are in the drug development process and is proud to have established and maintained a 99% on-time reporting record for commercial clients.