"Advancing the Implementation of Innovative Analytical Technologies in Pharmaceutical Manufacturing - Some Regulatory Considerations".

Analytical technologies and methods play a pivotal role in attribute understanding and control which are essential to the rapidly evolving field of pharmaceutical development and manufacturing. These technologies are advancing quickly, where innovations often involve both new scientific approaches and novel applications of established techniques. In many cases, the lack of harmonized global regulatory expectations presents challenges for the adoption of advanced technologies.

Advanced Hybrid Closed Loop Algorithm Use in Type 1 Diabetes: The French MiniMed™ Glycemic Control and Quality of Life Study.

Introduction: The MiniMed™ 780G system uses an advanced hybrid closed loop algorithm to improve outcomes in people with type 1 diabetes (T1D). The MiniMed™ 780G Glycemic Control and Quality of Life (EQOL) study aimed to provide routine clinical practice data on system effectiveness and associated patient-reported outcomes (PROs) in France.

Methods: Individuals aged ≥ 7 years with T1D were enrolled.

Implementation facilitators and barriers of person and family-centred emergency care.

Background: At the time of the research, the nurses in the designated hospital's emergency department did not implement person- and family-centred care to the detriment of patients and families. They were, however, eager to embark on the implementation of the recommendations of the Registered Nurses Association of Ontario for person- and family-centred care.

Aim: This study therefore aimed to explore and describe the possible implementation facilitators and barriers prior to the use of the association's recommendations.

Stress Reactivity, Wellbeing and Functioning in University Students: A Role for Autonomic Activity During Sleep.

Sleep is a key biological mechanism in promoting wellbeing and resilience to stress. This cross-sectional study examined connections between sleep, autonomic function, wellbeing, and stress reactivity in healthy individuals. Demographic, lifestyle, sleep, and psychological well-being information were collected from 85 healthy university students.

Experimental validation of a parenteral permitted daily exposure value for cleaning-induced degradants from recombinant therapeutic proteins with in vitro immunogenicity assays.

Multiproduct manufacturing of biotherapeutic proteins generate cleaning-induced protein degradants because of extreme pH and temperature conditions during the cleaning process. Cleaning Acceptance limits are calculated based on the maximum allowable carryover (MAC) assessment of the previously manufactured active pharmaceutical ingredient (API) - or drug product - based on the permitted daily exposure (PDE) of the previously manufactured API into the dose of subsequent product. In this study, we tested a previously determined PDE value for cleaning-induced protein degradants of 650 µg/dose.