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

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

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

Nanoparticle formulation for the development of a dog nanovaccine against Cystic Echinococcosis
Biologicals. 2023 Dec 14;85:101737. doi: 10.1016/j.biologicals.2023.101737. Online ahead of print.ABSTRACTCystic Echinococcosis is a cosmopolitan zoonosis closely linked to poverty and ignorance. It affects both cattle and humans, causing significant losses to both human and animal health. To date, there is no effective way to combat this. Our proposal focused on the formulation of poly (lactic-co-glycolic acid (PLGA) and Eudragit-RSPO polymeric nanoparticles, which are suitable to encapsulate an antigen for oral administration in dogs. This antigen, named EgFABP1, belonging to the family of fatty acid-binding proteins, wa...
Source: Biologicals : Journal of the International Association of Biological Standardization - December 15, 2023 Category: Biotechnology Authors: Cecilia Silvarrey Gabriela Alvite Adriana Esteves Source Type: research

Adjuvant effects of novel water/oil emulsion formulations on immune responses against infectious bronchitis (IB) vaccine in mice
Biologicals. 2023 Dec 14;85:101736. doi: 10.1016/j.biologicals.2023.101736. Online ahead of print.ABSTRACTVaccines have long made use of adjuvants to boost the immune response of the body and reduce the amount of vaccine needed as well as the expense of producing the vaccine. Many vaccine adjuvants are in development, but their application in veterinary vaccinations is restricted due to their lack of efficacy or undesirable side effects. For this reason, it is essential to develop novel adjuvants. To address the issue that the currently available infectious bronchitis (IB) vaccine often fails to produce sufficient immune r...
Source: Biologicals : Journal of the International Association of Biological Standardization - December 15, 2023 Category: Biotechnology Authors: Karrar Ali Mohammed Hasan Alsakini Furkan Ozan Çöven Ayse Nalbantsoy Source Type: research

Nanoparticle formulation for the development of a dog nanovaccine against Cystic Echinococcosis
Biologicals. 2023 Dec 14;85:101737. doi: 10.1016/j.biologicals.2023.101737. Online ahead of print.ABSTRACTCystic Echinococcosis is a cosmopolitan zoonosis closely linked to poverty and ignorance. It affects both cattle and humans, causing significant losses to both human and animal health. To date, there is no effective way to combat this. Our proposal focused on the formulation of poly (lactic-co-glycolic acid (PLGA) and Eudragit-RSPO polymeric nanoparticles, which are suitable to encapsulate an antigen for oral administration in dogs. This antigen, named EgFABP1, belonging to the family of fatty acid-binding proteins, wa...
Source: Biologicals : Journal of the International Association of Biological Standardization - December 15, 2023 Category: Biotechnology Authors: Cecilia Silvarrey Gabriela Alvite Adriana Esteves Source Type: research

Adjuvant effects of novel water/oil emulsion formulations on immune responses against infectious bronchitis (IB) vaccine in mice
Biologicals. 2023 Dec 14;85:101736. doi: 10.1016/j.biologicals.2023.101736. Online ahead of print.ABSTRACTVaccines have long made use of adjuvants to boost the immune response of the body and reduce the amount of vaccine needed as well as the expense of producing the vaccine. Many vaccine adjuvants are in development, but their application in veterinary vaccinations is restricted due to their lack of efficacy or undesirable side effects. For this reason, it is essential to develop novel adjuvants. To address the issue that the currently available infectious bronchitis (IB) vaccine often fails to produce sufficient immune r...
Source: Biologicals : Journal of the International Association of Biological Standardization - December 15, 2023 Category: Biotechnology Authors: Karrar Ali Mohammed Hasan Alsakini Furkan Ozan Çöven Ayse Nalbantsoy Source Type: research

An antibody-free evaluation of an mRNA COVID-19 vaccine
We describe the use of IDMS as an antibody-free means to accurately quantify expressed protein from mammalian cells transfected with mRNA vaccine.PMID:38096736 | DOI:10.1016/j.biologicals.2023.101738 (Source: Biologicals : Journal of the International Association of Biological Standardization)
Source: Biologicals : Journal of the International Association of Biological Standardization - December 14, 2023 Category: Biotechnology Authors: Paul J Branham Hans C Cooper Yulanda M Williamson Fabio N Najjar William J H Sutton Carrie L Pierce-Ruiz John R Barr Tracie L Williams Source Type: research

An antibody-free evaluation of an mRNA COVID-19 vaccine
We describe the use of IDMS as an antibody-free means to accurately quantify expressed protein from mammalian cells transfected with mRNA vaccine.PMID:38096736 | DOI:10.1016/j.biologicals.2023.101738 (Source: Biologicals : Journal of the International Association of Biological Standardization)
Source: Biologicals : Journal of the International Association of Biological Standardization - December 14, 2023 Category: Biotechnology Authors: Paul J Branham Hans C Cooper Yulanda M Williamson Fabio N Najjar William J H Sutton Carrie L Pierce-Ruiz John R Barr Tracie L Williams Source Type: research

Fifty years of advancing biologicals and beyond
Biologicals. 2023 Nov 21;85:101727. doi: 10.1016/j.biologicals.2023.101727. Online ahead of print.NO ABSTRACTPMID:37992427 | DOI:10.1016/j.biologicals.2023.101727 (Source: Biologicals : Journal of the International Association of Biological Standardization)
Source: Biologicals : Journal of the International Association of Biological Standardization - November 22, 2023 Category: Biotechnology Authors: Rajesh Gupta Griffiths Elwyn Girish Vyas Robin Thorpe Norman Baylor Source Type: research

Fifty years of advancing biologicals and beyond
Biologicals. 2023 Nov 21;85:101727. doi: 10.1016/j.biologicals.2023.101727. Online ahead of print.NO ABSTRACTPMID:37992427 | DOI:10.1016/j.biologicals.2023.101727 (Source: Biologicals : Journal of the International Association of Biological Standardization)
Source: Biologicals : Journal of the International Association of Biological Standardization - November 22, 2023 Category: Biotechnology Authors: Rajesh Gupta Griffiths Elwyn Girish Vyas Robin Thorpe Norman Baylor Source Type: research