Considerations from an International Regulatory and Pharmaceutical Industry (IQ MPS Affiliate) Workshop on the Standardization of Complex In Vitro Models in Drug Development

Abstract

In May 2022, there is an International Regulatory and Pharmaceutical Industry (Innovation and Quality [IQ] Microphysiological Systems [MPS] Affiliate) Workshop on the standardization of complex in vitro models (CIVMs) in drug development. This manuscript summarizes the discussions and conclusions of this joint workshop organized and executed by the IQ MPS Affiliate and the United States Food and Drug Administration (FDA). A key objective of the workshop is to facilitate discussions around opportunities and/or needs for standardization of MPS and chart potential pathways to increase model utilization in the context of regulatory decision making. Participation in the workshop included 200 attendees from the FDA, IQ MPS Affiliate, and 26 global regulatory organizations and affiliated parties representing Europe, Japan, and Canada. It is agreed that understanding global perspectives regarding the readiness of CIVM/MPS models for regulatory decision making and potential pathways to gaining acceptance is useful to align on globally. The obstacles are currently too great to develop standards for every context of use (COU). Instead, it is suggested that a more tractable approach may be to think of broadly applicable standards that can be applied regardless of COU and/or organ system. Considerations and next steps for this effort are described.

Bioprinting Soft 3D Models of Hematopoiesis using Natural Silk Fibroin‐Based Bioink Efficiently Supports Platelet Differentiation

“…The standardization of procedures is imperative when developing new ecosystems for preclinical studies and precision medicine. [ 6 , 17 ] Conventional manufacturing techniques, such as manual scaffolding and pipetting, fall short in achieving comparable thermostability, controllable motion, and precise deposition. Our primary reason for developing the silk bioink was to enable standardized protocols for 3D bioprinting of soft compositions, whose stability over long‐term culture is generally considered challenging.…”