The founding members of Bioworkshops are industrial veterans with deep understanding of the technical chemistry, manufacturing, and controls (CMC) requirement to reliably deliver biologics that meet international regulatory standards. Their experience in leading biologics development companies and biologics manufacturing organizations is a key ingredient in quickly establishing Bioworkshops and providing excellent services.
Highlights of the team’s experience in the past five years includes:
• Developing over 40 antibody products, lots of them are in late clinical stage.
• Manufacturing products for clinical trial in US, Australia, and China markets.
• Design, build and start-up of four biologics development and manufacturing centers.
• Compliance against US-FDA, NMPA, TFDA and TGA regulations to file IND and BLA.