ABSTRACT
As more and more cell and gene therapies are being developed and with the increasing number of regulatory approvals being obtained, there is an emerging and pressing need for industrial translation. Process efficiency, associated cost drivers and regulatory requirements are issues that need to be addressed before industrialisation of cell and gene therapies can be established. Automation has the potential to address these issues and pave the way towards commercialisation and mass production as it has been the case for 'classical' production industries. This review provides an insight into how automation can help address the manufacturing issues arising from the development of large-scale manufacturing processes for modern cell and gene therapy. The existing automated technologies with applicability in cell and gene therapy manufacturing are summarized and evaluated here.
Subject(s)
Automation , Cell- and Tissue-Based Therapy , Genetic Therapy , Bioreactors , HumansABSTRACT
We treated fifty-one cases of fracture of the shaft of the humerus with a functional method of treatment consisting of a plastic sleeve, individually molded or prefabricated. It maintained good alignment of the fragments and permitted rapid and uninterrupted osteogenesis. The early introduction of functional activity to the entire extremity appears to provide a desirable physiological environment conducive to rapid healing. Non-unions have not been encountered in nonpathological fractures. Healing time has been rapid, and there has been consistent restoration of motion of all joints prior to the completion of healing. The morbidity was minimum.
