Benchmark Biolabs Benchmark Biolabs

Clinical Services

Benchmarks’ USDA clinical and FDA pre-clinical expertise is focused on licensing our client's products or maintaining/clarifying existing product life cycles. Necessary facilities are in place to house surrogate models for small target or laboratory species in-house. Larger surrogate or target species are managed by our personnel at off-site locations.

Biosafety Level-3 Clinical 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 biotech, pharmaceutical, and academic institutes with regard to the development and testing of products targeted against highly pathogenic infectious disease. Our 6400 sq. ft. fully secured and contained Biosafety Level-3 clinical facility provides the means for a full array of services. The facility includes clean rooms, challenge rooms, a necropsy room, a hatchery, and associated laboratories. The BSL-3 facility provides a secure environment to work on small and surrogate-animal models for infectious agents that require high containment, including those on the current HHS and USDA Select Agents List.

In addition, Benchmark Biolabs has internal IACUC and IBC committees to assure full compliance with related animal-care needs and can respond to these issues in a timely manner.

Benchmark's Clinical Services include:

  • Immunogenicity
  • Safety and Challenge
  • Hyperimmunization for Antibody Production
  • Tissue and Immune-Cell Isolation.
  • Animal Model Development (Target or Surrogate),
  • Product Development
    • Novel Sampling Methods and Analytic Testing
      • Reduction
      • Refinement
      • Replacement
  • Serum- and Antibody-Response Assays Proof of Concept
  • Efficacy/Immunogenicity (i.e. Minimum Immunizing Dose)
  • Specialized Reagent Production (i.e. High Pathogenic Avian Influenza )
  • Interference
  • Vaccine Safety (Target and Surrogate Animal)
  • Field Safety
  • Data Capture
    • Flow Cytometry
    • CMI Bioassays
    • PCR Cytokine Cascades
    • Innate-Response Assays
    • Mucosal-Response Assays
  • Final Report Generation