Abstract

Equipment and Facility Considerations for 3D Bioprinting Based Production

William Whitford, Life Science Strategic Solutions Leader, DPS Group

Both 3D bioprinting technologies and applications are developing at an extremely fast pace. Diverse analytical and diagnostic products made using bioprinting technologies include microfluidic devices, organ-on-a-chip systems, and 3D in vitro tissue models for both drug research and clinical diagnostics. Therapeutic products are also beginning to be developed and these include bioprinted patches, tissues systems, and even organs. For the regulation of these products, the US FDA has spoken on the issue of the certification of 3D printed medical devices and have indicated they intend to codify issues related to bioprinting.  However, 3D printing technology is so dynamic that basic questions remain regarding practical and comprehensive requirements for the manufacturing of 3D bioprinted products or 3DBP (and personalized 3DBP), diagnostic and therapeutic materials, devices and cell therapies.  Facility and work-flow solutions are dependent upon many process design and compliance factors.  As technological and regulatory obstacles are being removed, the development of biomanufacturing operations raises new considerations. These considerations will include whether the 3DBP is traditional, patient-specific or customizable as well as hospital-made or mass produced.  The following will therefore include current thoughts on materials, equipment, facilities and workflows for the production and manufacturing of 3DBP.