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Influenza virus-like particles ( VLPs) are noninfectious particles resembling the influenza virus representing a promising vaccine alternative to inactivated influenza virions as antigens. Medicago inc. has developed a plant-based VLP manufacturing platform allowing the large-scale production of GMP-grade influenza VLPs. In this article, we report on the biochemical compositions of these plant-based influenza candidate vaccines, more particularly the characterization of the N-glycan profiles of the viral haemagglutinins H1 and H5 proteins as well as the tobacco-derived lipid content and residual impurities. Mass spectrometry analyses showed that all N-glycosylation sites of the extracellular domain of the recombinant haemagglutinins carry plant-specific complex-type N-glycans having core α(1,3)-fucose, core β(1,2)-xylose epitopes and Lewisa extensions. Previous phases I and II clinical studies have demonstrated that no hypersensibility nor induction of IgG or IgE directed against these glycans was observed. In addition, this article showed that the plant-made influenza vaccines are highly pure VLPs preparations while detecting no protein contaminants coming either from Agrobacterium or from the enzymes used for the enzyme-assisted extraction process. In contrast, VLPs contain few host cell proteins and glucosylceramides associated with plant lipid rafts. Identification of such raft markers, together with the type of host cell impurity identified, confirmed that the mechanism of VLP formation in planta is similar to the natural process of influenza virus assembly in mammals. [ABSTRACT FROM AUTHOR]

Background: Few studies have evaluated the quality of oral anticoagulant management by community pharmacists. There is no complete set of quality indicators available for this purpose., Objective: To develop a set of specific quality indicators to assess oral anticoagulant management by community pharmacists for patients with atrial fibrillation (AF)., Methods: Quality indicators were developed in 3 phases. In phase 1, potential quality indicators were generated based on clinical guidelines and a literature review. In phase 2, a modified RAND appropriateness method involving 2 rounds was implemented with 9 experts, who judged the appropriateness of quality indicators generated in phase 1 based on the extent to which they were accurate, based on evidence, relevant, representative of best practices, and measurable in community pharmacies. Phase 3 consisted of a feasibility assessment in 5 community pharmacies on 2 patients each., Results: The final set included 38 quality indicators grouped into 6 categories: documentation (n = 29), risk assessment (n = 3), clinical control (n = 1), clinical follow-up (n = 15), choice of therapy (n = 11), and interaction management (n = 8). The quality indicators referred to process of care (n = 34), clinical outcomes (n = 2), or structure of care (n = 2). There were 24 quality indicators related to vitamin K antagonists (VKAs), and 17 were related to direct oral anticoagulants (DOACs). To assess quality indicators, a questionnaire was developed for completion by community pharmacists for each patient, which included 17 questions about VKA patients and 12 questions about DOAC patients., Conclusions: A first set of quality indicators is now available to assess the quality of oral anticoagulant management by community pharmacists for patients with AF., Disclosures: This research was supported by the Réseau Québécois de recherche sur le médicament (RQRM); the Blueprint for Pharmacy in collaboration with Pfizer Canada; and the Cercle du Doyen of the Faculty of Pharmacy, University of Montreal. The study sponsors were not involved in the study design, data collection, data interpretation, the writing of the article, or the decision to submit the report for publication. Chartrand received a scholarship from the Fonds de Recherche du Québec en Santé (FRQ-S), the Réseau Québécois de recherche sur l'usage des médicaments with Pfizer, and the Faculty of Pharmacy, University of Montreal. Guénette holds a Junior-1 Clinician Researcher Award from the FRQ-S in partnership with the Société québécoise d'hypertension artérielle. Williamson holds a Junior-1 Career Award from the FRQ-S. Côté reported being a medical speaker for Bayer, Boehringer Ingelheim Canada, and Pfizer Canada. The other authors reported no conflicts of interest. Study concept and design were contributed by Lalonde, Chartrand, and Martin. Chartrand, Martin, and Lalonde collected the data, along with Brouillette, Côté, Huot, Landry, Martineau, Perreault, Williamson, and White-Guay. Data interpretation was performed by Chartrand, Gagnon, and Lalonde, along with Guénette and Martin. The manuscript was primarily written by Chartrand, along with Guénette and Lalonde, and revised by Chartrand, Guénette, and Lalonde, along with the other authors. A portion of this study's results was presented at the 4th RQRM Annual Meeting on September 22-23, 2014, in Orford, Quebec, Canada, in the form of an abstract, which was published in the Journal of Population Therapeutics and Clinical Pharmacology, 2014;21(2):e312.