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AmplifyBio Preclinical
Contract Research Organization Services

Whether you’re developing a traditional small molecule drug or advanced therapies, AmplifyBio is a preclinical CRO with the experience and capabilities to guide you through a single study or a full IND-enabling program. Our 220,000 square foot facility that includes 64 vivarium rooms has been in operation for 11 years and is led by scientists with over 30 years experience in CRO services as Battelle. Since spinning off as AmplifyBio, we’ve expanded our scientific staff, preclinical research services, and platform capabilities to serve a broader range of study end points and meet critical deadlines.

Preclinical Research Services and Study Endpoints

AmplifyBio offers cutting-edge preclinical research services & studies that provide a robust platform for early-stage drug discovery or developing advanced therapies. By understanding your commercial goals early, we design the most efficient path to achieve them. Our team of scientists with diverse and deep expertise in virology, immunology, molecular biology, pathology, regulatory compliance and method development will be true and accessible partners through the duration of your project. AmplifyBio’s preclinical CRO services include a comprehensive range of in vivo GLP and non-GLP preclinical studies in multiple species to thoroughly assess your drug development or advanced therapy needs. Areas of study include, but are not limited to: 

Focus Preclinical Research Services

Available Species

Lean on our experience across multiple species to assist you in devising the most appropriate study strategy. 

Immunodeficientimmunocompromised and transgenic or other genetically modified animal models are also available.

Small Animal Models:
  • Rodents – mice, rats, guinea pigs, hamsters
  • Nonrodents – ferrets, rabbits
Large Animal Models:
  • Minipigs and pigs
  • Canine
  • Nonhuman primates
AmplifyBio Preclinical Contract Research Organization Services
Preclinical CRO Lab Services

Routes of Administration

  • Intravenous
    (bolus or continuous infusion)
  • Intramuscular
  • Intraperitoneal
  • Parenteral
  • Oral
  • Tracheal Installation
  • Intrathecal
  • Intrathalamic
  • Intracisterna magna
  • Intracranial
  • Inhalation
  • Subcutaneous
  • Dermal

AmplifyBio Preclinical CRO Services FAQ

What are the main study types and services offered by AmplifyBio?

CRO Study Types:

 

Study design 

  • Species selection support
  • Bioanalytics – immunological and molecular studies
  • In vivo imaging
  • Anatomic and clinical pathology
  • Method development and validation
  • GLP and non-GLP studies
  • SEND data sets
  • In-house surgical capabilities
What makes AmplifyBio different from its competitors?

AmplifyBio is a preclinical CRO company built for the future on a foundation of experience from our history as Battelle. The hands-on care a study gets from our scientists, study directors, and project managers set AmplifyBio apart. At pivotal points in a study, our directors can communicate and strategize a path forward. The other significant differentiator for AmplifyBio is the recent expansion of bioanalytic capabilities to add molecular and immunological assays that complement in vivo work. That includes a brand-new digital PCR platform, spectral cytometry, in-vivo imaging, and improved immunological assay multiplexing ability to give a complete system picture of the drug’s function and characteristics at the preclinical stage.

What animal models are available for preclinical studies?

Small Animal Models:

  • Rodents – mice, rats, guinea pigs, hamsters
  • Nonrodents – ferrets, rabbits

 

Large Animal Models:

  • Minipigs and pigs
  • Canine
  • Nonhuman primates

 

Immunodeficientimmunocompromised and transgenic or other genetically modified animal models are also available.

What routes of administration and dosage forms do AmplifyBio use?
  • Intravenous
  • (bolus or continuous infusion)
  • Intramuscular
  • Intraperitoneal
  • Parenteral
  • Oral
  • Tracheal Installation
  • Intrathecal
  • Intrathalamic
  • Intracisterna magna
  • Intracranial
  • Inhalation
  • Subcutaneous
  • Dermal

 

Please inquire if you do not see a dose route you are looking for. AmplifyBio has developed a network of veterinary specialists that can assist us in bringing new dose routes on board for study needs.

What is the lead time for preclinical testing?

It varies by study type and species, but in general, AmplifyBio can start a preclinical study within 4-6 months of a signed agreement.

What is post contract engagement a preclinical study with AmplifyBio?

Once a study is initiated, clients stay in touch with business development, their project manager, and their study director throughout the duration. This team works together to ensure seamless communication throughout the study proposal, initiation, project setup, and execution. At AmplifyBio, we have a policy that our study directors manage a limited number of studies at one time to ensure that you can always get the data, answers, or any unexpected study modification suggestions on time.

What drug modalities or mechanisms of action can AmplifyBio test?

At AmplifyBio, we can conduct safety, toxicology, or efficacy testing for any drug modality for small and large molecule drugs. However, we have spent the last year increasing capabilities by investing in platforms that specifically help characterize and test cell and gene therapies at the preclinical phase.

Contact Us

With the expertise to design the right study for every model and flexibility for data-driven implementation, AmplifyBio is your partner to trust for Preclinical Contract Research Organization Services. Talk with us and discover how we can support your study and compliance requirements.