Microphysiological systems (MPS) are potentially transformative models that may offer unique insights into drug efficacy and safety and could be more predictive of in vivo biology than the in vitro models currently used in drug discovery and development. MPS are designed to mimic physiologically relevant functions of human or animal organs and tissues. The IQ MPS collectively defines MPS as going beyond traditional 2D sandwich culture or monolayers and include at least two of the following design aspects: having a multi-cellular environment within biopolymer or tissue-derived matrix, a 3D structure, mechanical factors such as stretch or perfusion (e.g. breathing, gut peristalsis, flow, etc.), incorporating primary or stem cell-derived cells, and/or inclusion of immune system components.
MPS have promising applications in mechanistic pharmacology or toxicology investigations, preclinical safety screening, and evaluation of drug disposition that could ultimately improve the translational success of drug candidates into the clinic, with the additional potential benefit of impacting the 3Rs (replacing, reducing, and refining animal use) in preclinical studies. Over the last decade the sophistication and capabilities of these tools have matured dramatically and the landscape has become more diverse and increasingly complex.
Yet, a number of challenges remain before these technologies can be fully incorporated into drug discovery and development, with one of the most critical being establishing robust qualification packages built around specific contexts of use (COUs). Focused efforts to characterize performance and assess the analytical validity of new tissue platforms will be needed to build a high level of confidence in the technologies in order to drive industrialization, advance regulatory acceptance and fully realize the promise of MPS.
To address these challenges and support the implementation of MPS in drug development, a group of over 20 pharmaceutical and biotechnology companies came together under the IQ Consortium for Innovation and Quality in Pharmaceutical Development to establish the IQ MPS affiliate.
The IQ MPS Affiliate aims to achieve the following: