AmplifyBio company

Preclinical CRO Services

 

Whether you are developing a traditional small molecule drug, or advanced therapies such as cell and gene 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 have expanded our scientific staff and platform capabilities to serve a broader range of study end points and meet critical timelines.

 

Services and Study Endpoints

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. Areas of study include, but are not limited to:

  • Bioanalytics
  • Anatomic and clinical pathology
  • Method development and validation
  • GLP and non-GLP studies
  • SEND data sets
  • Neurobehavioral studies

Focus Preclinical CRO 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
bioanalytics research
preclinical CRO

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

CRO Study Types:

  • General Toxicology
  • Safety Pharmacology
  • Efficacy Testing
  • Inhalation Toxicology
  • Neurobehavioral Studies
  • Oncolytic Virotherapy Studies
  • and more...

 

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

AmplifyBio is a preclinical CRO 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.

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.

  • 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.

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

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.

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.