An evolving biopharmaceutical industry requires advancements in biomanufacturing that offer increased productivity and improved economics without sacrificing process robustness. Accordingly, we have developed a new monoclonal antibody purification template comprised of flocculation-based clarification, capture by continuous multi-column protein A chromatography and flow-through polishing. The new process offers a robust, single-use manufacturing solution while significantly reducing overall cost of goods. Modeling studies verify that the individual clarification, capture and polishing solutions offer significant advantages as stand-alone unit operations. These technologies were also designed to be integrated into a continuous purification template. Process modeling studies have been used to highlight both cost and operational advantages of the new process template. Depending on scale, savings of more than 20% and 60% were seen for commercial and clinical operation, respectively. Integrating the technologies into a continuous process consistently offered additional cost advantages. During template development, process modeling was instrumental in highlighting the importance of identifying technologies that provided high product yield and purification factors. Additionally, high product concentration and eliminating the need for intermediate product dilution emerged as important considerations for newly developed unit operations. Combining experimental work with insights from modeling can significantly improve the outcome of product and process development.
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http://dx.doi.org/10.1016/j.jbiotec.2015.04.020 | DOI Listing |
J Intellect Dev Disabil
March 2021
Graduate School of Health, University of Technology Sydney, Sydney, Australia.
Emotion regulation is a challenge for many, in particular children with intellectual disabilities. To support understanding and the development of interventions in this area it is essential to identify valid and reliable measures. This systematic review aimed to identify measures that assess all five emotion regulation domains as described by the process model of emotion regulation; situation selection, situation modification, attention deployment, cognitive control, and response modulation.
View Article and Find Full Text PDFJ Intellect Dev Disabil
September 2021
School of Psychology, Grafton Campus, The University of Auckland, Auckland, New Zealand.
Background: Swallowing difficulties are common and complex in children with physical, behavioural, and cognitive needs. This study (i) describes mealtime management and (ii) identifies barriers and facilitators to implementation of a guideline for school-aged children with feeding difficulties in one specialist school.
Method: Three data sets were collected: (i) 51 school records, (ii) 48 meal observations, and (iii) seven staff interviews.
Res Social Adm Pharm
January 2025
Institute of Health Policy, Management and Evaluation, University of Toronto, 155 College Street, Suite 425, Toronto, Ontario, M5T 3M6, Canada; Research & Innovation, North York General Hospital, 4001 Leslie Street, Toronto, Ontario, M2K 1E1, Canada.
Purpose: Diversion or theft of controlled substances is a recognized problem affecting healthcare systems globally. The purpose of this study was to develop a framework for identifying and characterizing system factors leading to vulnerabilities for diversion within hospitals.
Methods: We applied a qualitative framework method, which involved 1) compiling a list of critical diversion vulnerabilities through observations and proactive risk analyses in the inpatient pharmacy, emergency department and intensive care unit of two Canadian hospitals; 2) coding the vulnerabilities into deductively and inductively derived themes and subthemes; and 3) building a conceptual framework.
Arab J Gastroenterol
January 2025
Department of Neonatology, Children's Hospital of Soochow University, Suzhou, PR China. Electronic address:
Background And Study Aims: Necrotizing enterocolitis (NEC) is a severe gastrointestinal disease in neonates. In vitro model is an indispensable tool to study the pathogenesis of NEC. This study explored the effects of different stress factors on intestinal injury in vitro.
View Article and Find Full Text PDFExp Cell Res
January 2025
Cardiovascular Center, College of Medicine, University of Cincinnati, Ohio-45267, United States of America; School of Chemical and Biotechnology, SASTRA Deemed University, Tirumalaisamudram, Thanjavur-613401, Tamil Nadu, India. Electronic address:
Multiple forms of cell death contribute significantly to cardiovascular pathologies, negatively impacting cardiac remodeling and leading to heart failure. While myocardial cell death has been associated with PM induced cardiotoxicity, the temporal dynamics of various cell death forms, such as apoptosis, ferroptosis, necroptosis, and pyroptosis, in relation to inflammatory processes, remain underexplored. This study examines the time-dependent onset and progression of these cell death pathways in the myocardium and their correlation with inflammation in a Wistar rat model.
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