[CellCAN Webinar]: Bioprinting at the nexus of medical device, biologic and cell therapy regulation

Aspect Biosystems uses a unique 3D bioprinting technology to fabricate cellularized tissues and devices for therapeutic applications and for pre-clinical research. Therapeutic areas of particular focus include orthopaedics, with the development of a knee meniscus replacement, and metabolic disease, where the team is developing an implantable pancreatic beta cell-containing tissue to cure patients with type-1-diabetes. Sam will discuss the various components that need to come together to successfully develop these therapeutics including, the 3D printing hardware, tissue design and printer control software, the biomaterials and the cells. Regulatory considerations for the two tissue programs will be discussed; the need for quality control systems, clinical and non-clinical studies, location of manufacturing sites, and supply chain are a few of the issues that will be addressed.