RESUMO
Several nanomedicine based medicinal products recently reached the market thanks to the drive of the COVID-19 pandemic. These products are characterized by criticality in scalability and reproducibility of the batches, and the manufacturing processes are now being pushed towards continuous production to face these challenges. Although the pharmaceutical industry, because of its deep regulation, is characterized by slow adoption of new technologies, recently, the European Medicines Agency (EMA) took the lead in pushing for process improvements using technologies already established in other manufacturing sectors. Foremost among these technologies, robotics is a technological driver, and its implementation in the pharma field should cause a big change, probably within the next 5 years. This paper aims at describing the regulation changes mainly in aseptic manufacturing and the use of robotics in the pharmaceutical environment to fulfill GMP (good manufacturing practice). Special attention is therefore paid at first to the regulatory aspect, explaining the reasons behind the current changes, and then to the use of robotics that will characterize the future of manufacturing especially in aseptic environments, moving from a clear overview of robotics to the use of automated systems to design more efficient processes, with reduced risk of contamination. This review should clarify the regulation and technological scenario and provide pharmaceutical technologists with basic knowledge in robotics and automation, as well as engineers with regulatory knowledge to define a common background and language, and enable the cultural shift of the pharmaceutical industry.
RESUMO
BACKGROUND: Recently, muscle synergy analysis has become a standard methodology for extracting coordination patterns from electromyographic (EMG) signals, and for the evaluation of motor control strategies in many contexts. Most previous studies have characterized upper-limb muscle synergies across a limited set of reaching movements. With the aim of future uses in motor control, rehabilitation and other fields, this study provides a comprehensive characterization of muscle synergies in a large set of upper-limb tasks and also considers inter-individual and environmental variability. METHODS: Sixteen healthy subjects performed upper-limb hand exploration movements for a comprehensive mapping of the upper-limb workspace, which was divided into several sectors (Frontal, Right, Left, Horizontal, and Up). EMGs from representative upper-limb muscles and kinematics were recorded to extract muscle synergies and explore the composition, repeatability and similarity of spatial synergies across subjects and movement directions, in a context of high variability of motion. RESULTS: Even in a context of high variability, a reduced set of muscle synergies may reconstruct the original EMG envelopes. Composition, repeatability and similarity of synergies were found to be shared across subjects and sectors, even if at a lower extent than previously reported. CONCLUSION: Extending the results of previous studies, which were performed on a smaller set of conditions, a limited number of muscle synergies underlie the execution of a large variety of upper-limb tasks. However, the considered spatial domain and the variability seem to influence the number and composition of muscle synergies. Such detailed characterization of the modular organization of the muscle patterns for upper-limb control in a large variety of tasks may provide a useful reference for studies on motor control, rehabilitation, industrial applications, and sports.