Preclinical/Clinical Services

Our USDA clinical and FDA pre-clinical expertise is focused on rational protocol designs to gain data for licensing of our client's product concept or maintaining/clarifying existing product life cycles.In house facilities are in place to house surrogate models for small target or laboratory species. Larger surrogate or target species are managed by our personnel at off-site locations.

BIOSAFETY LEVEL-3/ AVIAN INFLUENZA TESTING SITE

Benchmark owns and operates one of the very few Biosafety Level-3 facilities in North America. This facility is designed to support the growing needs of biotechnology and pharmaceutical companies, as well as academia, around the development and testing of products targeted against highly pathogenic infectious disease, including highly pathogenic strains of avian influenza. The 6400 sq. ft. Biosafety Level-3 clinical facility offers a full array of services, with physical and air barriers for clean rooms, challenge rooms, a necropsy room and a laboratory under a single roof. The BSL-3 facility provides an environment to work on small-animal and surrogate-animal models for infectious agents that require high containment, including those on the current HHS and USDA Select Agents List.

Some of the study protocols we perform are immunogenicity, safety and challenge studies, hyperimmunization for antibody production and tissue and immune-cell isolation. In addition, Benchmark Biolabs has internal IACUC and IBC committees to assure full compliance with related animal-care needs and respond to these issues in a timely manner.

Below are some of the services Benchmark offers with its clinical capabilities.

• Animal model development (target or surrogate), including extended data sets using novel sampling methods and analytic testing to enhance the data from each study to aid in reduction, refinement and replacement of animals in product development studies. Examples of this type of data capture include techniques such as:
  • flow cytometry
  • CMI bioassays
  • PCR cytokine cascades
  • Innate-response assays
  • Mucosal-response assays
  • serum- and antibody-response assays
• Proof of concept studies
• Designing and conducting (for submission of dossiers):
  • Efficacy/immunogenicity studies, including minimum immunizing dose studies and appropriate challenges
  • Production of specialized reagents, including high pathogenic avian influenza virus in our BSL3, select agent-approved facility
  • Interference studies that may include animal challenge
  • Vaccine safety studies (target and surrogate animal)
  • Field safety studies
  • Final report generation