Addressing Additive Manufacturing Material Biocompatibility at the Cellular Level

Much progress has been made over the last 10 years in the development of materials of additive manufacturing (AM) that are considered to be “biocompatible”. Generally, materials that are labeled as “Biocompatible” have passed one or more tests defined in the ISO-10993 Biocompatibility Standard, which can range from general cytotoxicity to skin sensitization. While these tests offer important information regarding the general safety of the materials, being rated as “biocompatible” offers little predictive value regarding the materials’ suitability for long term culture of cells and tissues. At the Southwest Research Institute (SwRI), we have been developing a novel and proprietary bioreactor platform for use in cell culture, expansion, and biomanufacturing. Our platform utilizes a scaffold whose geometry can only be produced using photopolymer-based 3D printing. When an off the shelf photopolymer resin suitable for cell culture could not be found, SwRI developed a post processing method that is generally material agnostic, utilizing chemical vapor deposition of parylene C, as well as additional surface modifications. We have demonstrated successful culture of multiple cell lines for up to 7 days, with no evidence of cytotoxicity, and viability comparable to that of traditional 2D culture flasks. In the proposed presentation, we will present the method, supporting data, and our recommendations for assessing “biocompatible” materials for suitability in cell and tissue culture going forward.