Biologics & Biosimilars

BSSI supports clients throughout the testing and development of biologics and biosimilars. With broad experience in this highly diverse field, BSSI is well versed in the distinct requirements for these products such as vaccines, gene based therapies, cellular biologics, and blood products.

  • Experimental study design
  • Analytics for screening, optimization and validation
  • Assay analytics including validation
  • Equivalence testing for biosimilars
  • Clinical protocol and study design, including sample size determination and randomization
  • Statistical analysis plans
  • Results reports including summary of safety and efficacy findings