Using Patient-Reported Outcomes in Two Program Examples Measuring Health Status in Primary Care: An Observational Study.

Background And Aims: Patient-reported outcome measures (PROMs) are increasingly used in primary care practices; however, the broad characteristics of this population pose unique challenges. Generic PROMs (e.g.

Status and future developments for downstream processing of biological products: Perspectives from the Recovery XIX yield roundtable discussions.

Governments and biopharmaceutical organizations aggressively leveraged expeditious communication capabilities, decision models, and global strategies to make a COVID-19 vaccine happen within a period of 12 months. This was an unusual effort and cannot be transferred to normal times. However, this focus on a single vaccine has also led to other treatments and drug developments being sidelined.

A Focus on Leadership Communication and Feeling Valued to Prevent Burnout and Turnover Among Healthcare Professionals.

Objective: The purpose of this study was to examine the relative importance of leadership communication in predicting burnout and intention to stay among faculty and staff while controlling for other factors such as satisfaction with compensation and work-home flexibility.

Methods: This study involved a secondary analysis of data derived from an organizational engagement survey that included 2336 faculty members (75% response rate) and 17,664 staff members (72% response rate).

Results: Effective leadership communication was a stronger predictor of burnout and intent to stay than satisfaction with compensation and work-home flexibility.

SWATH-MS as a strategy for CHO host cell protein identification and quantification supporting the characterization of mAb purification platforms.

Host cell proteins (HCPs) are process-related impurities expressed by the host cells during biotherapeutics' manufacturing, such as monoclonal antibodies (mAbs). Some challenging HCPs evade clearance during the downstream processing and can be co-purified with the molecule of interest, which may impact product stability, efficacy, and safety. Therefore, HCP content is a critical quality attribute to monitor and quantify across the bioprocess.

Process development and characterization for integrated continuous bioprocesses-Highlights from N-mAb.

The N-mAb case study was produced by the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) to support teaching and learning for both industry and to accelerate adoption of advanced manufacturing process technologies such as integrated continuous bioprocesses (ICB) for mAbs. Similar to the A-mAb case study, N-mAb presents the evolution of an integrated control strategy, from early clinical through process validation and commercial manufacturing with a focus on elements that are unique to integrated continuous bioprocesses. This publication presents a summary of the process design and characterization chapters to allow a greater focus on the unique elements relevant to that phase of development.