Bioprinted Advanced Therapeutics: Science, Hurdles, and Regulation

Bioprinting is an emerging technology that enables the fabrication of patient-specific, biologically active constructs. Proof-of-concept studies have demonstrated a regenerative potential for bioprinted advanced therapeutics in vascular, hepatic, cardiac, and cutaneous applications, yet translation to the clinic remains limited. The complexity of these products—living, multicomponent systems produced through additive manufacturing—creates challenges for reproducibility, sterility, and quality control that extend beyond those of conventionally manufactured biologics. This chapter provides a comprehensive review of the current state of bioprinting with emphasis on product development, manufacturing, and controls. We conduct a detailed analysis of key scientific and regulatory hurdles, including raw material qualification, comparative advantages of different bioprinting modalities, the necessity of end-to-end aseptic processing, robust inprocess monitoring, and the development of a scientifically sound potency assay that reflects complex mechanisms of action. Furthermore, we explore how nonclinical studies provide supportive evidence necessary for clinical translation, how one can navigate the intricate regulatory pathways in the United States, and how emerging standards and digital technologies may strengthen the quality framework. The goal is to provide a detailed, science-driven overview of the multifaceted challenges facing bioprinted advanced therapy products to facilitate translational discussion and advance the technology toward commercialization.