Bioprinting and 3D Printing – Will the FDA Regulate 3D Printing of Body Tissue and Body Parts?

Using 3D bioprinting for fabricating biological constructs typically involves dispensing cells onto a biocompatible scaffold using a successive layer-by-layer approach to generate tissue-like three-dimensional structures. Given that every tissue in the body is naturally compartmentalized of different cell types, many technologies for printing these cells vary in their ability to ensure stability and viability of the cells during the manufacturing process. Some of the methods that are used for 3D bioprinting of cells are photolithography, magnetic bioprinting, stereolithography, and cell extrusion.

An early-stage medical laboratory and research company, called Organovo, designs and develops functional, three-dimensional human tissue for medical research and therapeutic applications. The company utilizes its NovoGen MMX Bioprinter for 3D bioprinting. The printer is optimized to be able to print skin tissue, heart tissue, and blood vessels among other basic tissues. Organovo anticipates that the bioprinting of human tissues will accelerate the preclinical drug testing and discovery process, enabling treatments to be created more quickly and at lower cost. Additionally, Organovo has long-term expectations that this technology could be suitable for surgical therapy and transplantation. So far, they have signed research partnerships with various pharmaceutical companies, such as Pfizer, along with institutes such as Harvard Medical School.

3D-bioprinting attributes to significant advances in the medical field of tissue engineering by allowing for research to be done on innovative materials called biomaterials. Biomaterials are the materials adapted and used for printing three-dimensional objects. Some of the most notable are high-performance polymers and bioengineered substances that are usually stronger than the average bodily materials. These constituents can act as future substitutes, even improvements, for the original body materials. Alginate, for example, is an anionic polymer with many biomedical implications including feasibility, strong biocompatibility, low toxicity, and stronger structural ability in comparison to some of the body’s structural material

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