Pre-clinical & Clinical services

Xpress Biologics ensures a “one-stop-shop” service from the design of expression systems to the management of clinical trials. It encompasses the following activities:

  • consultancy, project set-up, risk assessment, regulatory support, project management
  • development of expression systems and of production and purification methods
  • production of biologics
  • scaling-up studies and industrialization

Example of the “one-stop-shop” service proposed for the production of antibody fragments:

  • antibody screening and reformatting
  • DNA optimization, gene synthesis, cloning in specific vectors and transformation in P. pastoris
  • R&D” grade production, purification and quality controls using “off-the-shelf” methods for in vitro trials
  • process optimization, scaling-up studies and full QC development
  • GLP grade production, purification and quality controls
  • management of pre-clinical trials
  • transfer to a manufacturing company for GMP grade production
  • management of clinical trials