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Viral clearance capability of monoclonal antibody purification
Biologicals. 2024 Feb 21;85:101751. doi: 10.1016/j.biologicals.2024.101751. Online ahead of print.ABSTRACTViral clearance steps are routinely included in monoclonal antibody purification processes to safeguard product from potential virus contamination. These steps are often experimentally studied using product-specific feeds and parameters for each project to demonstrate viral clearance capability. However, published evidence suggests that viral clearance capability of many of these steps are not significantly impacted by variations in feed material or process parameter within commonly used ranges. The current investigati...
Source: Biologicals : Journal of the International Association of Biological Standardization - February 22, 2024 Category: Biotechnology Authors: Kang Cai Jennifer Anderson Etienne Utiger Gisela Ferreira Source Type: research

The role of real-world evidence for regulatory and public health decision-making for Accelerated Vaccine Deployment- a meeting report
This report summarises presentations and discussions from a conference on the role of Real-World Evidence (RWE) in expediting vaccine deployment. Attended by regulatory bodies, public health entities, and industry experts, the gathering was a collaborative exchange of experiences and recommendations for leveraging RWE for vaccine deployment. RWE proved instrumental in refining decision-making processes to optimise dosing regimens, enhance guidance on target populations, and steer vaccination strategies against emerging variants. Participants felt that RWE was successfully integrated into lifecycle management, encompassing ...
Source: Biologicals : Journal of the International Association of Biological Standardization - February 15, 2024 Category: Biotechnology Authors: Kaatje Bollaerts Chlo é Wyndham-Thomas Elizabeth Miller Hector S Izurieta Steve Black Nick Andrews Michelle Rubbrecht Fran Van Heuverswyn Pieter Neels Source Type: research

Ethical approval for controlled human infectious model clinical trial protocols - A workshop report
Biologicals. 2024 Feb 12;85:101748. doi: 10.1016/j.biologicals.2024.101748. Online ahead of print.ABSTRACTControlled Human Infectious Model studies (CHIM) involve deliberately exposing volunteers to pathogens. To discuss ethical issues related to CHIM, the European Vaccine Initiative and the International Alliance for Biological Standardization organised the workshop "Ethical Approval for CHIM Clinical Trial Protocols", which took place on May 30-31, 2023, in Brussels, Belgium. The event allowed CHIM researchers, regulators, ethics committee (EC) members, and ethicists to examine the ethical criteria for CHIM and the role(...
Source: Biologicals : Journal of the International Association of Biological Standardization - February 13, 2024 Category: Biotechnology Authors: Euzebiusz Jamrozik Katherine Littler Irina Meln Wim Van Molle Sandra Morel Ole F Olesen Michelle Rubbrecht Shobana Balasingam Pieter Neels Source Type: research

Fourth Controlled Human Infection Model (CHIM) meeting - CHIMs in endemic countries, May 22-23, 2023
Biologicals. 2024 Feb 12:101747. doi: 10.1016/j.biologicals.2024.101747. Online ahead of print.ABSTRACTEarlier meetings laid the foundations for Controlled Human Infection Models (CHIMs), also known as human challenge studies and human infection studies, including Good Manufacturing Practice (GMP) production of the challenge agent, CHIM ethics, environmental safety in CHIM, recruitment, community engagement, advertising and incentives, pre-existing immunity, and clinical, immunological, and microbiological endpoints. The fourth CHIM meeting focused on CHIM studies being conducted in endemic countries. Over the last ten yea...
Source: Biologicals : Journal of the International Association of Biological Standardization - February 13, 2024 Category: Biotechnology Authors: Melissa Kapulu Lucinda Manda-Taylor Shobana Balasingam Gary Means Mikal Ayiro Malungu Philip Bejon Primus Che Chi Christopher Chiu E Chandler Church Rodrigo Correa-Oliveira Nicholas Day Anna Durbin Moses Egesa Claudia Emerson Kondwani Jambo Roli Mathur Wo Source Type: research

A validated polyclonal antiserum-based immunoassay for assessment of HPV 16 L1 relative potency
Biologicals. 2024 Feb 8;85:101742. doi: 10.1016/j.biologicals.2023.101742. Online ahead of print.ABSTRACTVaccine potency is typically evaluated using an assay that acts as a surrogate for biological activity. Although in vivo vaccines better represent human immunological responses, in vitro assays are preferred due to lower variability, higher throughput, easier validation and ethical considerations. In in vitro determination of Human Papillomavirus (HPV), Virus-like particle (VLP) vaccine potency currently depends on monoclonal antibody assays. However, these reagents are hard to obtain and currently are not available com...
Source: Biologicals : Journal of the International Association of Biological Standardization - February 10, 2024 Category: Biotechnology Authors: Reihaneh Mirhassani Ehsan Seyedjafari Behrouz Vaziri Source Type: research

Fourth Controlled Human Infection Model (CHIM) meeting, CHIM regulatory issues, May 24, 2023
Biologicals. 2024 Feb 10:101745. doi: 10.1016/j.biologicals.2024.101745. Online ahead of print.ABSTRACTMany aspects of Controlled Human Infection Models (CHIMs, also known as human challenge studies and human infection studies) have been discussed extensively, including Good Manufacturing Practice (GMP) production of the challenge agent, CHIM ethics, environmental safety in CHIM, recruitment, community engagement, advertising and incentives, pre-existing immunity, and clinical, immunological, and microbiological endpoints. The fourth CHIM meeting focused on regulation of CHIM studies, bringing together scientists and regul...
Source: Biologicals : Journal of the International Association of Biological Standardization - February 10, 2024 Category: Biotechnology Authors: Marco Cavaleri David Kaslow Eric Boateng Wilbur H Chen Christopher Chiu Robert K M Choy Rodrigo Correa-Oliveira Anna Durbin Moses Egesa Malick Gibani Melissa Kapulu Melba Katindi Ally Olotu Pongphaya Pongsuwan Michelo Simuyandi Bruno Speder Kawsar R Talaa Source Type: research

Molecular characterization of Anaplasma ovis Msp4 protein in strains isolated from ticks in Turkey: A multi-epitope synthetic vaccine antigen design against Anaplasma ovis using immunoinformatic tools
This study aimed to reveal potential vaccine candidate epitopes in Msp4 protein using sequence data from Anaplasma ovis isolates and then to design a multi-epitope protein to be used in vaccine formulations against Anaplasma ovis. For this purpose, Msp4 gene was sequenced from Anaplasma ovis isolates (n:6) detected in ticks collected from sheep in Turkey and the sequence data was compared with previous sequences from different countries in order to detect the variations of Msp4 gene/protein. Potential vaccine candidate and diagnostic epitopes were predicted using various immunoinformatics tools. Among the discovered vaccin...
Source: Biologicals : Journal of the International Association of Biological Standardization - February 7, 2024 Category: Biotechnology Authors: Ahmet Efe K öseoğlu H üseyin Can Mervenur G üvendi Sedef Erkunt Alak Aysu De ğirmenci Döşkaya Muhammet Karakavuk Mert D öşkaya Cemal Ün Source Type: research

Regulatory workshop on challenge strain development and GMP manufacture - A stakeholder meeting report
Biologicals. 2024 Feb 2:101746. doi: 10.1016/j.biologicals.2024.101746. Online ahead of print.ABSTRACTWithin the Innovative Health Initiative (IHI) Inno4Vac CHIMICHURRI project, a regulatory workshop was organised on the development and manufacture of challenge agent strains for Controlled Human Infection Model (CHIM) studies. Developers are often uncertain about which GMP requirements or regulatory guidelines apply but should be guided by the 2022 technical white paper "Considerations on the Principles of Development and Manufacturing Qualities of Challenge Agents for Use in Human Infection Models" (published by hVIVO, We...
Source: Biologicals : Journal of the International Association of Biological Standardization - February 3, 2024 Category: Biotechnology Authors: Nicoletta Corti Christopher Chiu Rebecca J Cox Clarisse Demont Jeanne-Marie Devaster Othmar G Engelhardt Andrew Gorringe Khaole Hassan Marcel Hoefnagel Ingrid Kamerling Oleg Krut Chelsea Lane Reinhard Liebers Catherine Luke Wim Van Molle Sandra Morel Piet Source Type: research

Novel vaccine candidates of Bordetella pertussis identified by reverse vaccinology
Biologicals. 2024 Jan 12;85:101740. doi: 10.1016/j.biologicals.2023.101740. Online ahead of print.ABSTRACTWhooping cough is a disease caused by Bordetella pertussis, whose morbidity has increased, motivating the improvement of current vaccines. Reverse vaccinology is a strategy that helps identify proteins with good characteristics fast and with fewer resources. In this work, we applied reverse vaccinology to study the B. pertussis proteome and pangenome with several in-silico tools. We analyzed the B. pertussis Tohama I proteome with NERVE software and compared 234 proteins with B. parapertussis, B. bronchiseptica, and B....
Source: Biologicals : Journal of the International Association of Biological Standardization - January 13, 2024 Category: Biotechnology Authors: Gloria Paulina Monterrubio-L ópez Jos é Luis Llamas-Monroy Ángel Antonio Martínez-Gómez Karen Delgadillo-Guti érrez Source Type: research