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.