The Regulatory Challenge of 3D Bioprinting

Abstract

New developments in additive manufacturing and regenerative medicine have the potential to radically disrupt the traditional pipelines of therapy development and medical device manufacture. These technologies present a challenge for regulators because traditional regulatory frameworks are designed for mass manufactured therapies, rather than bespoke solutions. 3D bioprinting technologies present another dimension of complexity through the inclusion of living cells in the fabrication process. Herein we overview the challenge of regulating 3D bioprinting in comparison to existing cell therapy products as well as custom-made 3D printed medical devices. We consider a range of specific challenges pertaining to 3D bioprinting in regenerative medicine, including classification, risk, standardization and quality control, as well as technical issues related to the manufacturing process and the incorporated materials and cells.

In Situ Bioprinting: Process, Bioinks, and Applications

“…Similarly, regulatory and ethical considerations are paramount for the translation of in situ bioprinting from the laboratory to clinical settings. 166 As the field matures, comprehensive frameworks that ensure safety, standardization, and ethical practices are essential for gaining regulatory approval and public acceptance. Ethical concerns arise with in situ bioprinting, particularly in cases in which the technology involves manipulating human cells or creating personalized tissues.…”

“…Similarly, regulatory and ethical considerations are paramount for the translation of in situ bioprinting from the laboratory to clinical settings . As the field matures, comprehensive frameworks that ensure safety, standardization, and ethical practices are essential for gaining regulatory approval and public acceptance.…”

Guiding organs-on-chips towards applications: a balancing act between integration of advanced technologies and standardization

“…Accelerating standard development should facilitate the adoption of bioprinted OoC models in both academia and industry, as well as improve regulatory acceptance of these models. With this in mind, the development of novel bioprinting constructs coupled with OoC devices should be concomitant with the ample characterization of bioinks and hardware and analysis workflows and be shared by multiple independent laboratories to confirm robustness and reproducibility (Mladenovska et al, 2023). Finally, output generation and data collection from such high-content models needs to be standardized so that the performance of the different models can be assessed and compared to currently accepted references.…”

Enhancing quality control in bioprinting through machine learning

“…Regarding the regulatory barriers, currently there is no clear classification of what a bioprinted product is in the framework of already existing regulations [35,36]. This is a major concern, as product classification helps defining the relevant regulations that the product should comply with to guarantee its safety and cost-effectiveness, as well as the marketing authorization procedures for its commercialization [37,38].…”