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