About AmplifyBio

Advancing Science for Humankind

Our mission is to create pathways for novel treatment advances, cutting-edge technologies, and new research frontiers to advance medical breakthroughs, treatments, and cures for disease.

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.

Contract Research Organization Drug Development Solutions

Why AmplifyBio?

Our list of capabilities continues to grow. These are only a sample of the capabilities we provide:

  • Comprehensive guidance for study design, species selection, and responsive data management.
  • Assisting informed decisions early and often with our bioanalytic lab for characterization and efficacy evaluation using both immunology and molecular testing.
  • The use of in-house surgical suites for extensive control and reduced quarantine time. Use consists of implantation of safety pharmacology monitoring devices, surgical dose routes, and bone marrow biopsies.
  • Anatomic and clinical pathology capabilities. ACVP Board-Certified Pathologists are in-house including DVM/PhD experts in toxicological pathology.
  • Regulatory expertise, GLP and non-GLP studies, quality accreditations, INHAND pathology compliance, and SEND data sets.

Amplified with Expertise

At AmplifyBio, our expertise and thought leadership extends across numerous industries.

Quality and Accreditation

AmplifyBio knows you put extensive trust in our teams. That’s why every study partnership is founded in assurance:

Quality

  • Independent quality assurance unit
  • GLP compliance (21 CFR Part 58)
  • Electronic records compliance (21 CFR Part 11)
  • Respected and experienced RQAP-GLP credentialed auditors


Accreditation

  • Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC). Continued full accreditation AAALAC unit # 000446 [AB: 001894].
  • Office of Laboratory Animal Welfare (OLAW). Approved/renewed through November 30, 2025. Assurance # D21-01118.

U.S. Department of Agriculture (USDA) Class R Research Facility. Approved/renewed through August 2024. Registration/license #31-R-0136.

AmplifyBio Headquarters

Located in West Jefferson, Ohio, our state-of-the-art facility is designed for efficiency and innovation in every corner.

  • 220,000 square-foot facility
  • >65,000 square feet of laboratory space
  • 34,500 square-foot vivarium
  • Technical pathology, histology, and analytics labs
  • On-site surgical suite
  • Custom workflows for complex study designs
AmplifyBio Headquarters in West Jefferson, Ohio

Contact AmplifyBio

Partner with the AmplifyBio team if you need a dedicated CRO resource. For questions or more information about our resources and expertise, contact us today.