ABSTRACT
This new edition presents a fully-updated and expanded look at current Good Manufacturing Practice (cGMP) for cell therapy products. It provides a complete discussion of facility design and operation including details specific to cord blood banking, cell processing, vector production and qualification of a new facility. Several chapters cover facility infrastructure including cleaning and maintenance, vendor qualification, writing a Standard Operating Procedure, staff training, and process validation. The detailed and invaluable product information covers topics like labelling, release and administration, transportation and shipment, et al. Further chapters cover relevant topics like writing and maintaining investigational new drug applications, support opportunities in North America and the European Union, commercial cell processing and quality testing services, and financial considerations for academic GMP facilities. A chapter on future directions rounds out Cell Therapy: cGMP Facilities and Manufacturing making it essential reading for any cell therapy professional involved in the development, use, or management of this type of facility. © Springer Nature Switzerland AG 2009, 2022, Corrected Publication 2022.
ABSTRACT
The number of the elderly experiencing cognitive disorders or dementia including Alzheimer's has been increasing worldwide. During COVID-19 pandemic, they are vulnerable not only to the coronavirus, but also to the social isolation with no family visits. The elderly are increasingly depressed, resisting care, refusing medications, and showing signs of agitation. These behavioral disturbances are leading to an increased use of psychotropic medications and/or increased hospitalizations to the already overloaded healthcare systems. To address this, the authors focus on a mobile intervention, named AlzhaTV, as a suite of mobile apps. The intervention, not requiring any technical interaction from the elderly, is available on both Android and iOS platforms. The mobile intervention has the potential to improve the quality of life and reduction in medications for the elderly. The results show that multiple personalized and non-personalized videos can be transmitted over existing wireless networks. During the current and future pandemics and disasters, AlzhaTV can actively support the elderly.
ABSTRACT
Water distribution network (WDN) is a human-centered infrastructure that is indispensable for modern cities worldwide. In addition to optimizing the operation and management (O&M) of WDNs under the current state, water utilities should be able to manage uncertain and risk conditions for improving their O&M efficiency. Although the disintegration of large WDNs into permanent district metered areas (DMAs) is an O&M innovation based on water leakage monitoring and pressure management, its network redundancy and reliability diminish under anomalous conditions. Therefore, this study proposed a design and operation procedure to obtain optimal, self-adaptive DMA configurations for various plausible abnormal scenarios. The proposed method is based on multiscenario simulation and optimization, comprising two phases: (1) design of optimal DMA layout for each scenario using the pressure uniformity index to optimize the placement of flow meters and gate valves, and (2) dynamic transformation of the base DMA configuration into an adaptive DMA layout adapting to abnormal conditions and optimization of the locations and statuses of the control valves. Moreover, we used a real-world WDN to demonstrate the effectiveness of the proposed approach, and the obtained results revealed the efficiency and appropriate performance of the adaptive DMA layouts for sustainable adaptation of WDNs under anomalous conditions.