Stem cells and cell therapies
Other important emerging modalities reviewed at ESACT 2022 were stem cells and immune cells; there were several presentations examining the development of these cell-based products, some of which are included in this special issue. For example, Vives et al . evaluated the impact of 3D printing to preserve critical quality attributes in bone tissue regeneration using natural hydrogel scaffolds. Interestingly, hyaluronic acid, gelatin, and fibrin applied as bioinks enabled optimal recovery of mesenchymal stromal cells while also preserving proliferation and osteogenic capacity by reducing shear stress and providing structural support. In addition, Costa et al . described an integrated bioreactor and downstream process enabling the scalability of mesenchymal stromal cells production of extracellular vesicles, which yielded considerably higher yields than those achieved with static cultures while preserving the quality of the EVs and their ability to stimulate angiogenesis. Fed-batch alone or in combination with perfusion were described by Fernandes-Platzummer et al. as a process to generate bone marrow-derived MsCs and MSC-EV in stirred tank bioreactors. To complement these experimental investigations, Lewiset al . proposes an in silico approach (using mathematical models) to describe cell-to-cell communications important to immune cells cell functions and ultimately immunotherapies.
An overriding topic at the conference (and the field of biomanufacturing) was the challenges and opportunities of introducing new therapeutic platforms. This special issue starts with a publication by Schaefer et al . that discuss the barriers, including technology, business, regulatory and people-driven concerns, that arise when introducing new therapeutic technologies and present enablers for reducing the gaps between advances and innovation in biopharmaceutical manufacturing and final therapy delivery to patients.