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Chemometric models for on-line process monitoring have become well established in pharmaceutical bioprocesses. The main drawback is the required calibration effort and the inflexibility regarding system or process changes. So, a recalibration is necessary whenever the process or the setup changes even slightly. With a large and diverse Raman dataset, however, it was possible to generate generic partial least squares regression models to reliably predict the concentrations of important metabolic compounds, such as glucose-, lactate-, and glutamine-indifferent CHO cell cultivations. The data for calibration were collected from various cell cultures from different sites in different companies using different Raman spectrophotometers. In testing, the developed “generic” models were capable of predicting the concentrations of said compounds from a dilution series in FMX-8 mod medium, as well as from an independent CHO cell culture. These spectra were taken with a completely different setup and with different Raman spectrometers, demonstrating the model flexibility. The prediction errors for the tests were mostly in an acceptable range (<10% relative error). This demonstrates that, under the right circumstances and by choosing the calibration data carefully, it is possible to create generic and reliable chemometric models that are transferrable from one process to another without recalibration.

Although we have recently reported the involvement of neonatal Fc receptor (FcRn) in intranasal transport, the transport mechanisms are far from being elucidated. Ex vivo porcine olfactory tissue, primary cells from porcine olfactory epithelium (OEPC) and the human cell line RPMI 2650 were used to evaluate the permeation of porcine and human IgG antibodies through the nasal mucosa. IgGs were used in their wild type and deglycosylated form to investigate the impact of glycosylation. Further, the expression of FcRn and Fc-gamma receptor (FCGR) and their interaction with IgG were analyzed. Comparable permeation rates for human and porcine IgG were observed in OEPC, which display the highest expression of FcRn. Only traces of porcine IgGs could be recovered at the basolateral compartment in ex vivo olfactory tissue, while human IgGs reached far higher levels. Deglycosylated human IgG showed significantly higher permeation in comparison to the wild type in RPMI 2650 and OEPC, but insignificantly elevated in the ex vivo model. An immunoprecipitation with porcine primary cells and tissue identified FCGR2 as a potential interaction partner in the nasal mucosa. Glycosylation sensitive receptors appear to be involved in the uptake, transport, but also degradation of therapeutic IgGs in the airway epithelial layer.

Purpose Evidence-based interventions (EBIs) are essential to improve the well-being and neurocognitive outcomes of pediatric cancer patients; however, considerable barriers hamper the implementation of these tools. The present study assessed health care professionals’ (HCP) perceived barriers and facilitators to the implementation of a specific EBI for pediatric oncology in a standardized manner to define effective solutions and practical recommendations. Methods An adapted version of the Consolidated Framework for Implementation Research (CFIR) questionnaire was applied to inquire n  = 31 HCPs in pediatric oncology about the five domains of implementation. Results While most ‘ intervention characteristics ’ were considered beneficial for implementation, various aspects of the ‘ inner ’ and ‘ outer setting ’ were considered problematic. The most prevalent barriers included a shortage in resources , poor integration of EBIs into policies and lacking incentives such as user benefits. Concrete proposed and realized steps to facilitate effective implementation include a patient - focused design and continuous evaluation and adaption of the tool, a detailed EBI user manual and application workshops , as well as regular interdisciplinary meetings to improve communication. Regarding the internal and external settings, involving policy makers , establishing psychosocial care in the insurance system and increasing awareness by sharing evidence are essential steps for improved implementation. Conclusion Based on standardized implementation evaluation, various targeted actions could be defined and implemented to facilitate successful implementation of EBIs in pediatric oncology. The results emphasize that psychosocial care must become an integral part of treatment standards and public health policies to ensure that effective psychosocial interventions for improved wellbeing and neurocognitive skills successfully reach pediatric cancer patients. Trial registration number ClinicalTrials.gov Identifier: NCT04474678 (July 17th 2020).