Freeze drying, or lyophilization is widely used for biopharmaceuticals to improve the long term storage stability of labile molecules. This review examines general theory and practice of rational lyophilization of biopharmaceuticals. Formulation development involving the selection of appropriate excipients, their associated physical properties, and mechanism of action in achieving a stable drug product are primary considerations for a successful lyophilization program. There are several parameters considered critical on the basis of their relationship to lyophilization cycle development and protein product stability. This along with the importance of analytical methods to provide insight toward understanding properties of drug product stability and cake structure are discussed. Also, aspects of instability found in lyophilized biopharmaceutical products, their degradation pathways and control are elucidated. Finally, container-closure requirements and drug product handling are described in context of the caveats to avoid compromising drug product quality.
Abstract. We present the organization, structure, instrumentation,
and measurements of the Northeast Corridor greenhouse gas observation
network. This network of tower-based in situ carbon dioxide and methane
observation stations was established in 2015 with the goal of quantifying
emissions of these gases in urban areas in the northeastern United States.
A specific focus of the network is the cities of Baltimore, MD, and
Washington, DC, USA, with a high density of observation stations in these
two urban areas. Additional observation stations are scattered throughout
the northeastern US, established to complement other existing urban and
regional networks and to investigate emissions throughout this complex
region with a high population density and multiple metropolitan areas. Data
described in this paper are archived at the National Institute of Standards
and Technology and can be found at https://doi.org/10.18434/M32126
(Karion et al., 2019).
Purpose
– The purpose of this paper is to identify Australian managers’ attitudes and understandings regarding workforce diversity management (WDM) and the practices and incorporation of WDM in organisations.
Design/methodology/approach
– Methodology is quantitative. A questionnaire in the form of a self-administered survey instrument was mailed to 650 managers (325 HR managers and 325 other managers) in Sydney, Melbourne and Brisbane.
Findings
– The research found that workforce diversity is not especially well understood or appreciated; especially by non-HR managers. Organisations appear generally not to prioritise WDM and levels of senior manager engagement with the topic are tentative. Statistical analysis highlighted considerable divergence of opinion across the surveyed group.
Research limitations/implications
– As an exploratory study, further research is encouraged to better understand cause and effect relationships pertaining to the findings.
Practical implications
– There are implications for HR managers or those in related roles who might design, implement and promote WDM initiatives. There are implications for consultants, employees and senior managers regarding education, awareness and support of diversity objectives.
Originality/value
– Addresses a gap in the literature by looking at contemporary attitudes and practices regarding WDM in Australian organisations. Provides the first empirical comparison between HR and other managers on the topic.
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