Monitoring of Visible Particles in Parenteral Products by Manual Visual Inspection-Reassessing Size Threshold and Other Particle Characteristics that Define Particle Visibility.

Visible particles are a critical quality attribute for parenteral products and must be monitored. A carefully designed, executed, and controlled drug product manufacturing process including a final 100 % visual inspection and appropriate end-product controls ensures that visible particles are consistently minimized and demonstrates that the injectable DP is practically free from visible particles. Visual inspection, albeit appearing as a simple analytical procedure, requires several technical and operational controls to ensure adequate performance.

Microbiota and cancer: current understanding and mechanistic implications.

During last few decades, role of microbiota and its importance in several diseases has been a hot topic for research. The microbiota is considered as an accessory organ for maintaining normal physiology of an individual. These microbiota organisms which normally colonize several epithelial surfaces are known to secrete several small molecules leading to local and systemic effects on normal biological processes.

Relational and caring partnerships: (re)creating equity, genuineness, and growth in mentoring faculty relationships.

Mentoring in academia has traditionally and currently been prescriptive and institutionally driven. The purpose of this paper is to deconstruct these current mentoring practices with a critical feminist stance. New understandings are shared and gained through dialogue, relevant literature, and performativity to (re)create and name a caring and relational partnership.

The lived experience of Australian opioid replacement therapy recipients in a community-based program in regional Victoria.

Introduction And Aims: Treatment of opioid dependence through opioid replacement therapy is widely recognised as effective. Nonetheless, while there has been a community-based program in the state of Victoria for over two decades, consumer experiences have received little attention. This study aimed to describe the experiences of opioid replacement therapy consumers living in rural and regional areas of the state.

Acute stress alters the rates of degradation of cardiac muscle proteins.

Stressful experiences can have detrimental effects on many aspects of health and wellbeing. The zebrafish (Danio rerio) is a widely used model for stress research and a stress phenotype can be induced by manipulating the environmental conditions and social interactions. In this study we have combined a zebrafish stress model with the measurement of degradation rates of soluble cardiac muscle proteins.

The educational impact of web-based and face-to-face patient deterioration simulation programs: An interventional trial.

Background: There are international concerns relating to the management of patient deterioration. The "failure to rescue" literature identifies that nursing staff miss cues of deterioration and often fail to call for assistance. Simulation-based educational approaches may improve nurses' recognition and management of patient deterioration.

Optimizing the Use of Discharge Medication Lists in Nursing Facilities.

Objective: To highlight the need to optimize the use of discharge medication lists in nursing facilities.

Setting: In January 2014, the care transitions (CT) pharmacists at Frederick Memorial Hospital, Frederick, Maryland, began a pilot project in which they identified and followed high-risk patients transitioning from hospital to nursing facility and from nursing facility to home.

Practice Description: This pilot project served as a needs assessment to identify opportunities to improve patients' transition from nursing facility to home with the goal of reducing hospital readmissions.

Proteomic variation and diversity in clinical Streptococcus pneumoniae isolates from invasive and non-invasive sites.

Streptococcus pneumoniae is responsible for a variety of invasive and non-invasive human infections. There are over 90 serotypes of S. pneumoniae differing in their ability to adapt to the different niches within the host.

Colorectal cancer-inflammatory bowel disease nexus and felony of Escherichia coli.

Colorectal cancer (CRC) has a multifactorial etiology. Although the exact cause of CRC is still elusive, recent studies have indicated microbial involvement in its etiology. Escherichia coli has emerged as an important factor in CRC development since the bacterium can cause changes in the gut that lead to cancerous transformation.

Identification of potential biomarkers of hepatotoxicity by plasma proteome analysis of arsenic-exposed carp Labeo rohita.

Arsenic (As) is a toxic environmental contaminant and potential human carcinogen. Chronic intake of arsenic-contaminated water and food leads to arsenicosis, a major public health problem in many parts of the world. Early detection of arsenic toxicity would greatly benefit patients; however, the detection of arsenicosis needs to be done early before onset of severe symptoms in which case the tools used for detection have to be both sensitive and reliable.

Comparing Simplification Strategies for the Skeletal Muscle Proteome.

Skeletal muscle is a complex tissue that is dominated by the presence of a few abundant proteins. This wide dynamic range can mask the presence of lower abundance proteins, which can be a confounding factor in large-scale proteomic experiments. In this study, we have investigated a number of pre-fractionation methods, at both the protein and peptide level, for the characterization of the skeletal muscle proteome.

Dietary Yeast Cell Wall Extract Alters the Proteome of the Skin Mucous Barrier in Atlantic Salmon (Salmo salar): Increased Abundance and Expression of a Calreticulin-Like Protein.

In order to improve fish health and reduce use of chemotherapeutants in aquaculture production, the immunomodulatory effect of various nutritional ingredients has been explored. In salmon, there is evidence that functional feeds can reduce the abundance of sea lice. This study aimed to determine if there were consistent changes in the skin mucus proteome that could serve as a biomarker for dietary yeast cell wall extract.

Optimizing the Use of Discharge Medication Lists in Nursing Facilities.

Objective: To highlight the need to optimize the use of discharge medication lists in nursing facilities.

Setting: In January 2014, the care transitions (CT) pharmacists at Frederick Memorial Hospital, Frederick, Maryland, began a pilot project in which they identified and followed high-risk patients transitioning from hospital to nursing facility and from nursing facility to home.

Practice Description: This pilot project served as a needs assessment to identify opportunities to improve patients' transition from nursing facility to home with the goal of reducing hospital readmissions.

Qualification of a Quantitative Method for Monitoring Aspartate Isomerization of a Monoclonal Antibody by Focused Peptide Mapping.

Unlabelled: Aspartate (Asp) isomerization is a common post-translational modification of recombinant therapeutic proteins that can occur during manufacturing, storage, or administration. Asp isomerization in the complementarity-determining regions of a monoclonal antibody may affect the target binding and thus a sufficiently robust quality control method for routine monitoring is desirable. In this work, we utilized a liquid chromatography-mass spectrometry (LC/MS)-based approach to identify the Asp isomerization in the complementarity-determining regions of a therapeutic monoclonal antibody.

A Biopharmaceutical Industry Perspective on the Control of Visible Particles in Biotechnology-Derived Injectable Drug Products.

Unlabelled: Regulatory monographs in Europe and the United States require drug products for parenteral administration to be "practically free" or "essentially free" of visible particles, respectively. Both terms have been used interchangeably and acknowledge the probabilistic nature of visual particle inspection. The probability of seeing a particle in a drug product container varies according to the size and nature of the particles as well as container and inspection conditions.

Determining synthesis rates of individual proteins in zebrafish (Danio rerio) with low levels of a stable isotope labelled amino acid.

The zebrafish is a powerful model organism for the analysis of human cardiovascular development and disease. Understanding these processes at the protein level not only requires changes in protein concentration to be determined but also the rate at which these changes occur on a protein-by-protein basis. The ability to measure protein synthesis and degradation rates on a proteome-wide scale, using stable isotope labelling in conjunction with mass spectrometry is now a well-established experimental approach.

Stigma and Developmental Disabilities in Nursing Practice and Education.

Individuals with developmental disabilities (DD) experience stigma, discrimination, and barriers, including access to appropriate health care, that restrict their ability to be equal participants in society. In this study, underlying contexts, assumptions, and ways of acting are investigated that perpetuate inequalities and pejorative treatment toward those with disabilities. Several nurse researchers and educators suggest specific content for, or approaches to, education about DD.

Transitional Care Units: Expanding the Role of Pharmacists Providing Patient Care.

Objective: To describe two innovative practice models that expand pharmacy services within a nursing facility's transitional care unit (TCU) to meet the needs of patients transitioning to subacute or community care.

Setting: TCU in a hospital-based vs. a community-based facility.

Semi-Quantitative Analysis of Inherent Visible Particles for Biopharmaceutical Products.

Unlabelled: Visible particles must be monitored as part of the control strategy for pharmaceutical products. Extraneous (foreign) particles are not acceptable in parenteral drug products. In biopharmaceuticals, formation of protein particles is recognized as an inherent quality attribute.

Streptococcus pneumoniae proteomics: determinants of pathogenesis and vaccine development.

Streptococcus pneumoniae is a major pathogen that is responsible for a variety of invasive diseases. The bacteria gain entry initially by establishing a carriage state in the nasopharynx from where they migrate to other sites in the body. The worldwide distribution of the bacteria and the severity of the diseases have led to a significant level of interest in the development of vaccines against the bacteria.

Subvisible (2-100 μm) particle analysis during biotherapeutic drug product development: Part 2, experience with the application of subvisible particle analysis.

Measurement and characterization of subvisible particles (including proteinaceous and non-proteinaceous particulate matter) is an important aspect of the pharmaceutical development process for biotherapeutics. Health authorities have increased expectations for subvisible particle data beyond criteria specified in the pharmacopeia and covering a wider size range. In addition, subvisible particle data is being requested for samples exposed to various stress conditions and to support process/product changes.

Universal method for the determination of nonionic surfactant content in the presence of protein.

A new analytical method has been developed for the quantitative determination of ethylene glycol-containing nonionic surfactants, such as polyethylene glycol 8000, polysorbate 80, and Pluronic F-68. These surfactants are commonly used in pharmaceutical protein preparations, thus, testing in the presence of protein is required. This method is based on the capillary gas chromatographic analysis of ethylene glycol diacetate formed by hydrolysis and acetylation of surfactants that contain ethylene glycol.

Proteomic changes in the brain of the western painted turtle (Chrysemys picta bellii) during exposure to anoxia.

During anoxia, overall protein synthesis is almost undetectable in the brain of the western painted turtle. The aim of this investigation was to address the question of whether there are alterations to specific proteins by comparing the normoxic and anoxic brain proteomes. Reductions in creatine kinase, hexokinase, glyceraldehyde-3-phosphate dehydrogenase, and pyruvate kinase reflected the reduced production of adenosine triphosphate (ATP) during anoxia while the reduction in transitional endoplasmic reticulum ATPase reflected the conservation of ATP or possibly a decrease in intracellular Ca(2+).

Characterization of the initial level and migration of silicone oil lubricant in empty prefilled syringes for biologics using infrared spectroscopy.

Unlabelled: Glass prefillable syringes are lubricated with silicone oil to ensure functionality and a consistent injection for the end user. If excessive silicone is applied, droplets could potentially result in aggregation of sensitive biopharmaceuticals or clouding of the solution. Therefore, monitoring and optimization of the applied silicone layer is critical for prefilled syringe development.

Proteomics and protein analyses of ovine and caprine body fluids: current studies and future promises.

Our knowledge of the physiology and health of small ruminants, specifically sheep and goats, is frequently obtained by extrapolating information from other species, for example the cow. However, there are important genetic, physiological and anatomical differences between small and large ruminants that cannot be ignored. This review considers the advances that have been made in the investigation of sheep and goat physiology through the use of proteomic technologies.