Breathing Life into Science C

History

Benchmark Biolabs is a company with a clear focus on streamlining and supporting the development process for biotechnology and pharmaceutical innovators. The company was founded in 1996 to keep up with the continuing evolution of science, and to improve the practical applications of the research-to-commercialization process.

Benchmark Biolabs’ business model is the realization of the founding team’s long-held belief in the commercial and technical value of innovation. Benchmark set out to addresses the major inefficiencies and complexities that make the current biological-development process disconnected, prolonged, and expensive.

Benchmark targeted and acquired the best expertise and technology within the biological development sector, resulting in a business that offers a truly integrated service across the entire development continuum. Customers could select distinctive parts of the mix or a start to finish solution. We started cutting timelines, adding value, and reducing the overall cost of commercialization, all while maintaining the highest standards of quality.

Here are a few examples from the growing list of noteworthy achievements since Benchmark’s inception:

Achievements

  • Developed FDA regulated process-development method for new probiotics being developed for human use.
  • Developed a robust manufacturing procedure for a DNA vaccine.
  • Co-developed an in vitro potency-release assay and identity test for intestinal parasite species based on viability.
  • Co-developed the first plant-derived vaccine approved by the USDA.
    • Design and management of manufacturing facility.
    • First potency and identity tests for plant-derived vaccines.
    • First plant-derived master cell stocks for the purpose of vaccines.
  • Redrafted and prepared documents for evaluation of Category 1, 2 and -3 recombinant organisms. The USDA/CVB licensing and policy division uses this document to evaluate new technologies that enter the regulatory development procedures for vaccines and immunotherapeutics.
  • Established one of the first privately-owned BSL3 clinical testing facilities in North America.
  • Provided one of first data packages to CVB for using absolute values in place of traditional relative values for validated potency tests for vaccine release, which provides an absolute value for vaccine dosing rather than a relative value that is correlated to a reference. The end result is a focused assay on the target antigen rather than a composite reference or assembled vaccine.
  • Developed single-dose emulsion vaccines based on recombinant subunit or inactivated antigens.
  • Developed surrogate models to test live, recombinant-live and inactivated products for animal and human use.
  • Designed and managed a manufacturing site modeled for molecular farming of transgenic animals.
  • Developed training programs in methods validation and qualification of reference standards for customers.
  • Developed a first-in-class manufacturing service model for clients with USDA/CVB licensed products.
  • Developed a customized reagent qualified to meet the limitation and variances for its intended use.