Research Article510.1016/j.biologicals.2023.101680Rapid production and free distribution of a synthetic RNA material to support SARS-CoV-2 molecular diagnostic testingMay 01, 2023BiologicalsMegan H Cleveland + 6 more +6CiteListenSave
Research Article710.1016/j.biologicals.2023.101664Quantitation of free cyanide using ion exchange chromatography in Neisseria meningitidis serogroups A, C, W, Y and X conjugates used in vaccine manufacture.Feb 01, 2023BiologicalsSaurav Ghosh + 8 more +8CiteListenSave
Research Article410.1016/j.biologicals.2022.06.002Antivenoms, hepatitis B vaccine and oral polio vaccine can be considered for storage and handling outside the cold chain following the innovative ‘controlled temperature chain’ approachJul 01, 2022BiologicalsShereen H Mohamed + 3 more +3CiteListenSave
Research Article510.1016/j.biologicals.2022.05.003Development and validation of a novel luciferase reporter gene assay to detect pyrogenJun 01, 2022BiologicalsCan Wang + 8 more +8CiteListenSave
Front Matter10.1016/s1045-1056(22)00035-5Aims and Scope/Editorial Board/Publishing DetailsJun 01, 2022BiologicalsCiteListenSave
Research Article610.1016/j.biologicals.2022.03.001WHO informal consultation on revision of guidelines on evaluation of similar biotherapeutic products, virtual meeting, 30 June – 2 July 2021Apr 01, 2022BiologicalsMeenu Wadhwa + 49 more +49The WHO informal consultation was held to promote the revision of WHO guidelines on evaluation of similar biotherapeutic products (SBPs) adopted by the Expert Committee on Biological Standardization (ECBS) in 2009. It was agreed in the past consultations that the evaluation principles in the guidelines are still valid, but a review was recommended to provide more clarity and case-by-case flexibility. The opportunity was therefore taken to review the experience and identify areas where the current guidance could be more permissive without compromising its basic principles, and where additional explanation could be provided regarding the possibility of reducing the amount of data needed for regulatory approval. The meeting participants applauded the leading role taken by the WHO in providing a much-needed streamlined approach for development and evaluation of SBPs which will provide efficient and cost-effective product development and increase patient access to treatments. It was recognized that the principles as currently described in the draft WHO guidelines are based on sound science and experience gained over the last fifteen years of biosimilar approvals. However, since these guidelines when finalised will constitute the global standard for biosimilar evaluation and assist national regulatory authorities in establishing revised guidance and regulatory practice in this complex area, it was felt that further revision and clarity on certain perspectives in specific areas was necessary to dispel uncertainties arising in the current revised version. This report describes the principles in the draft guidelines, including topics discussed and consensus reached.Read moreCiteListenSave
Research Article110.1016/j.biologicals.2022.02.002National Control Laboratories in quality healthcare-a roadblock for substandard biopharmaceuticalsFeb 25, 2022BiologicalsRashmi Shrivastava + 6 more +6CiteListenSave
Front Matter10.1016/s1045-1056(22)00008-2Aims and Scope/Editorial Board/Publishing DetailsJan 01, 2022BiologicalsCiteListenSave
Research Article510.1016/j.biologicals.2021.06.002Immunization effect of lipopolysaccharide antigen in conjugation with PLGA nanoparticles as a nanovaccine against Brucella melitensis infectionJun 21, 2021BiologicalsMasoud Maleki + 1 more +1CiteListenSave
Research Article710.1016/j.biologicals.2021.05.003An adventitious agent-free clonal cell line that is highly susceptible to foot -and-mouth disease virusJun 04, 2021BiologicalsM Larocco + 8 more +8CiteListenSave