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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

Efficient extraction of adventitious virus nucleic acid using commercially available methods
This study sought to examine the nucleic acid extraction efficiency of three viral candidates in relevant background matrices using four different extraction methods. Three model adventitious viruses, Minute virus of Mice, Porcine Circovirus, and Feline Leukemia Virus, were diluted within a variety of background matrices relevant to pharmaceutical production methods. Upon extraction, the nucleic acid was quantified using droplet digital PCR methods. Four nucleic acid extraction methods were assessed, including commercially available kits and manual extraction methods. Each method recovered nucleic acid post-extraction for ...
Source: Biologicals : Journal of the International Association of Biological Standardization - December 29, 2023 Category: Biotechnology Authors: William G Valiant Jon Borman Kang Cai Peter M Vallone Source Type: research

Efficient extraction of adventitious virus nucleic acid using commercially available methods
This study sought to examine the nucleic acid extraction efficiency of three viral candidates in relevant background matrices using four different extraction methods. Three model adventitious viruses, Minute virus of Mice, Porcine Circovirus, and Feline Leukemia Virus, were diluted within a variety of background matrices relevant to pharmaceutical production methods. Upon extraction, the nucleic acid was quantified using droplet digital PCR methods. Four nucleic acid extraction methods were assessed, including commercially available kits and manual extraction methods. Each method recovered nucleic acid post-extraction for ...
Source: Biologicals : Journal of the International Association of Biological Standardization - December 29, 2023 Category: Biotechnology Authors: William G Valiant Jon Borman Kang Cai Peter M Vallone Source Type: research

Efficient extraction of adventitious virus nucleic acid using commercially available methods
This study sought to examine the nucleic acid extraction efficiency of three viral candidates in relevant background matrices using four different extraction methods. Three model adventitious viruses, Minute virus of Mice, Porcine Circovirus, and Feline Leukemia Virus, were diluted within a variety of background matrices relevant to pharmaceutical production methods. Upon extraction, the nucleic acid was quantified using droplet digital PCR methods. Four nucleic acid extraction methods were assessed, including commercially available kits and manual extraction methods. Each method recovered nucleic acid post-extraction for ...
Source: Biologicals : Journal of the International Association of Biological Standardization - December 29, 2023 Category: Biotechnology Authors: William G Valiant Jon Borman Kang Cai Peter M Vallone Source Type: research

Efficient extraction of adventitious virus nucleic acid using commercially available methods
This study sought to examine the nucleic acid extraction efficiency of three viral candidates in relevant background matrices using four different extraction methods. Three model adventitious viruses, Minute virus of Mice, Porcine Circovirus, and Feline Leukemia Virus, were diluted within a variety of background matrices relevant to pharmaceutical production methods. Upon extraction, the nucleic acid was quantified using droplet digital PCR methods. Four nucleic acid extraction methods were assessed, including commercially available kits and manual extraction methods. Each method recovered nucleic acid post-extraction for ...
Source: Biologicals : Journal of the International Association of Biological Standardization - December 29, 2023 Category: Biotechnology Authors: William G Valiant Jon Borman Kang Cai Peter M Vallone Source Type: research

Efficient extraction of adventitious virus nucleic acid using commercially available methods
This study sought to examine the nucleic acid extraction efficiency of three viral candidates in relevant background matrices using four different extraction methods. Three model adventitious viruses, Minute virus of Mice, Porcine Circovirus, and Feline Leukemia Virus, were diluted within a variety of background matrices relevant to pharmaceutical production methods. Upon extraction, the nucleic acid was quantified using droplet digital PCR methods. Four nucleic acid extraction methods were assessed, including commercially available kits and manual extraction methods. Each method recovered nucleic acid post-extraction for ...
Source: Biologicals : Journal of the International Association of Biological Standardization - December 29, 2023 Category: Biotechnology Authors: William G Valiant Jon Borman Kang Cai Peter M Vallone Source Type: research

Efficient extraction of adventitious virus nucleic acid using commercially available methods
This study sought to examine the nucleic acid extraction efficiency of three viral candidates in relevant background matrices using four different extraction methods. Three model adventitious viruses, Minute virus of Mice, Porcine Circovirus, and Feline Leukemia Virus, were diluted within a variety of background matrices relevant to pharmaceutical production methods. Upon extraction, the nucleic acid was quantified using droplet digital PCR methods. Four nucleic acid extraction methods were assessed, including commercially available kits and manual extraction methods. Each method recovered nucleic acid post-extraction for ...
Source: Biologicals : Journal of the International Association of Biological Standardization - December 29, 2023 Category: Biotechnology Authors: William G Valiant Jon Borman Kang Cai Peter M Vallone Source Type: research

Efficient extraction of adventitious virus nucleic acid using commercially available methods
This study sought to examine the nucleic acid extraction efficiency of three viral candidates in relevant background matrices using four different extraction methods. Three model adventitious viruses, Minute virus of Mice, Porcine Circovirus, and Feline Leukemia Virus, were diluted within a variety of background matrices relevant to pharmaceutical production methods. Upon extraction, the nucleic acid was quantified using droplet digital PCR methods. Four nucleic acid extraction methods were assessed, including commercially available kits and manual extraction methods. Each method recovered nucleic acid post-extraction for ...
Source: Biologicals : Journal of the International Association of Biological Standardization - December 29, 2023 Category: Biotechnology Authors: William G Valiant Jon Borman Kang Cai Peter M Vallone Source Type: research

Evaluation of next-generation sequencing performance for in vitro detection of viruses in biological products
Biologicals. 2023 Dec 15;85:101739. doi: 10.1016/j.biologicals.2023.101739. Online ahead of print.ABSTRACTNext-Generation Sequencing (NGS) can detect nucleic acid sequences in a massively parallel sequencing. This technology is expected to be widely applied for the detection of viral contamination in biologics. The recently published ICH-Q5A (R2) draft indicates that NGS could be an alternative or supplement to in vitro viral tests. To examine the performance of NGS for the in vitro detection of viruses, adenovirus type 5 (Ad5), a model virus, was inoculated into Vero cells, which are the most popular indicator cells for t...
Source: Biologicals : Journal of the International Association of Biological Standardization - December 16, 2023 Category: Biotechnology Authors: Takamasa Hirai Kiyoko Kataoka Yuzhe Yuan Keisuke Yusa Yoji Sato Kazuhisa Uchida Ken Kono Source Type: research

Evaluation of next-generation sequencing performance for in vitro detection of viruses in biological products
Biologicals. 2023 Dec 15;85:101739. doi: 10.1016/j.biologicals.2023.101739. Online ahead of print.ABSTRACTNext-Generation Sequencing (NGS) can detect nucleic acid sequences in a massively parallel sequencing. This technology is expected to be widely applied for the detection of viral contamination in biologics. The recently published ICH-Q5A (R2) draft indicates that NGS could be an alternative or supplement to in vitro viral tests. To examine the performance of NGS for the in vitro detection of viruses, adenovirus type 5 (Ad5), a model virus, was inoculated into Vero cells, which are the most popular indicator cells for t...
Source: Biologicals : Journal of the International Association of Biological Standardization - December 16, 2023 Category: Biotechnology Authors: Takamasa Hirai Kiyoko Kataoka Yuzhe Yuan Keisuke Yusa Yoji Sato Kazuhisa Uchida Ken Kono Source Type: research

Evaluation of next-generation sequencing performance for in vitro detection of viruses in biological products
Biologicals. 2023 Dec 15;85:101739. doi: 10.1016/j.biologicals.2023.101739. Online ahead of print.ABSTRACTNext-Generation Sequencing (NGS) can detect nucleic acid sequences in a massively parallel sequencing. This technology is expected to be widely applied for the detection of viral contamination in biologics. The recently published ICH-Q5A (R2) draft indicates that NGS could be an alternative or supplement to in vitro viral tests. To examine the performance of NGS for the in vitro detection of viruses, adenovirus type 5 (Ad5), a model virus, was inoculated into Vero cells, which are the most popular indicator cells for t...
Source: Biologicals : Journal of the International Association of Biological Standardization - December 16, 2023 Category: Biotechnology Authors: Takamasa Hirai Kiyoko Kataoka Yuzhe Yuan Keisuke Yusa Yoji Sato Kazuhisa Uchida Ken Kono Source Type: research