Biologicals : Journal of the International Association of Biological Standardization This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

Glycosylation differences of an anti-VEGF monoclonal antibody (PRO-169) and its extensive comparison with Bevacizumab
In this study, analytical characterization showed that PRO-169 had glycosylation differences in comparison to BVZ reference product (RP); since it had more content of G1F, G2F, sialic acid and high mannose. Further investigation was performed to evaluate if differences between both products would affect the efficacy and safety profile of PRO-169. PRO-169 had no alteration in its in vitro biological activity; moreover, no cytotoxicity or immunogenicity concerns should be expected as demonstrated by different orthogonal methods at analytical, in vitro and in vivo assays. These results support moving to the clinical testing o...
Source: Biologicals : Journal of the International Association of Biological Standardization - September 25, 2023 Category: Biotechnology Authors: Mayra G Qui ñonez-Alvarado Paulina Ch ávez-Hurtado Jes ús C Caro-Palomera Oriana L Ni ño-Trejo Jos é I Jiménez-Dolores Patricia Mu ñoz-Villegas Leopoldo Baiza-Dur án Juan D Quintana-Hau Source Type: research

Glycosylation differences of an anti-VEGF monoclonal antibody (PRO-169) and its extensive comparison with Bevacizumab
In this study, analytical characterization showed that PRO-169 had glycosylation differences in comparison to BVZ reference product (RP); since it had more content of G1F, G2F, sialic acid and high mannose. Further investigation was performed to evaluate if differences between both products would affect the efficacy and safety profile of PRO-169. PRO-169 had no alteration in its in vitro biological activity; moreover, no cytotoxicity or immunogenicity concerns should be expected as demonstrated by different orthogonal methods at analytical, in vitro and in vivo assays. These results support moving to the clinical testing o...
Source: Biologicals : Journal of the International Association of Biological Standardization - September 25, 2023 Category: Biotechnology Authors: Mayra G Qui ñonez-Alvarado Paulina Ch ávez-Hurtado Jes ús C Caro-Palomera Oriana L Ni ño-Trejo Jos é I Jiménez-Dolores Patricia Mu ñoz-Villegas Leopoldo Baiza-Dur án Juan D Quintana-Hau Source Type: research

Glycosylation differences of an anti-VEGF monoclonal antibody (PRO-169) and its extensive comparison with Bevacizumab
In this study, analytical characterization showed that PRO-169 had glycosylation differences in comparison to BVZ reference product (RP); since it had more content of G1F, G2F, sialic acid and high mannose. Further investigation was performed to evaluate if differences between both products would affect the efficacy and safety profile of PRO-169. PRO-169 had no alteration in its in vitro biological activity; moreover, no cytotoxicity or immunogenicity concerns should be expected as demonstrated by different orthogonal methods at analytical, in vitro and in vivo assays. These results support moving to the clinical testing o...
Source: Biologicals : Journal of the International Association of Biological Standardization - September 25, 2023 Category: Biotechnology Authors: Mayra G Qui ñonez-Alvarado Paulina Ch ávez-Hurtado Jes ús C Caro-Palomera Oriana L Ni ño-Trejo Jos é I Jiménez-Dolores Patricia Mu ñoz-Villegas Leopoldo Baiza-Dur án Juan D Quintana-Hau Source Type: research

Glycosylation differences of an anti-VEGF monoclonal antibody (PRO-169) and its extensive comparison with Bevacizumab
In this study, analytical characterization showed that PRO-169 had glycosylation differences in comparison to BVZ reference product (RP); since it had more content of G1F, G2F, sialic acid and high mannose. Further investigation was performed to evaluate if differences between both products would affect the efficacy and safety profile of PRO-169. PRO-169 had no alteration in its in vitro biological activity; moreover, no cytotoxicity or immunogenicity concerns should be expected as demonstrated by different orthogonal methods at analytical, in vitro and in vivo assays. These results support moving to the clinical testing o...
Source: Biologicals : Journal of the International Association of Biological Standardization - September 25, 2023 Category: Biotechnology Authors: Mayra G Qui ñonez-Alvarado Paulina Ch ávez-Hurtado Jes ús C Caro-Palomera Oriana L Ni ño-Trejo Jos é I Jiménez-Dolores Patricia Mu ñoz-Villegas Leopoldo Baiza-Dur án Juan D Quintana-Hau Source Type: research

Glycosylation differences of an anti-VEGF monoclonal antibody (PRO-169) and its extensive comparison with Bevacizumab
In this study, analytical characterization showed that PRO-169 had glycosylation differences in comparison to BVZ reference product (RP); since it had more content of G1F, G2F, sialic acid and high mannose. Further investigation was performed to evaluate if differences between both products would affect the efficacy and safety profile of PRO-169. PRO-169 had no alteration in its in vitro biological activity; moreover, no cytotoxicity or immunogenicity concerns should be expected as demonstrated by different orthogonal methods at analytical, in vitro and in vivo assays. These results support moving to the clinical testing o...
Source: Biologicals : Journal of the International Association of Biological Standardization - September 25, 2023 Category: Biotechnology Authors: Mayra G Qui ñonez-Alvarado Paulina Ch ávez-Hurtado Jes ús C Caro-Palomera Oriana L Ni ño-Trejo Jos é I Jiménez-Dolores Patricia Mu ñoz-Villegas Leopoldo Baiza-Dur án Juan D Quintana-Hau Source Type: research

Glycosylation differences of an anti-VEGF monoclonal antibody (PRO-169) and its extensive comparison with Bevacizumab
In this study, analytical characterization showed that PRO-169 had glycosylation differences in comparison to BVZ reference product (RP); since it had more content of G1F, G2F, sialic acid and high mannose. Further investigation was performed to evaluate if differences between both products would affect the efficacy and safety profile of PRO-169. PRO-169 had no alteration in its in vitro biological activity; moreover, no cytotoxicity or immunogenicity concerns should be expected as demonstrated by different orthogonal methods at analytical, in vitro and in vivo assays. These results support moving to the clinical testing o...
Source: Biologicals : Journal of the International Association of Biological Standardization - September 25, 2023 Category: Biotechnology Authors: Mayra G Qui ñonez-Alvarado Paulina Ch ávez-Hurtado Jes ús C Caro-Palomera Oriana L Ni ño-Trejo Jos é I Jiménez-Dolores Patricia Mu ñoz-Villegas Leopoldo Baiza-Dur án Juan D Quintana-Hau Source Type: research

Regulatory perspective for quality evaluation of lipid nanoparticle-based mRNA vaccines in China
Biologicals. 2023 Sep 12;84:101700. doi: 10.1016/j.biologicals.2023.101700. Online ahead of print.ABSTRACTIn recent years, urgent unmet medical needs due to the COVID-19 pandemic have accelerated the application of mRNA technology in vaccine development, leading to some of the first approvals of mRNA vaccines in human history by regulatory agencies around the world. For market authorization, comprehensive chemistry, manufacturing and control (CMC) information is required to assure the safety and quality consistency of mRNA vaccines. Evaluating mRNA vaccines for new virus variants poses a challenge for regulators, given the...
Source: Biologicals : Journal of the International Association of Biological Standardization - September 14, 2023 Category: Biotechnology Authors: Jiaqi Lu Wei Wei Wu He Source Type: research

Regulatory perspective for quality evaluation of lipid nanoparticle-based mRNA vaccines in China
Biologicals. 2023 Sep 12;84:101700. doi: 10.1016/j.biologicals.2023.101700. Online ahead of print.ABSTRACTIn recent years, urgent unmet medical needs due to the COVID-19 pandemic have accelerated the application of mRNA technology in vaccine development, leading to some of the first approvals of mRNA vaccines in human history by regulatory agencies around the world. For market authorization, comprehensive chemistry, manufacturing and control (CMC) information is required to assure the safety and quality consistency of mRNA vaccines. Evaluating mRNA vaccines for new virus variants poses a challenge for regulators, given the...
Source: Biologicals : Journal of the International Association of Biological Standardization - September 14, 2023 Category: Biotechnology Authors: Jiaqi Lu Wei Wei Wu He Source Type: research

Regulatory perspective for quality evaluation of lipid nanoparticle-based mRNA vaccines in China
Biologicals. 2023 Sep 12;84:101700. doi: 10.1016/j.biologicals.2023.101700. Online ahead of print.ABSTRACTIn recent years, urgent unmet medical needs due to the COVID-19 pandemic have accelerated the application of mRNA technology in vaccine development, leading to some of the first approvals of mRNA vaccines in human history by regulatory agencies around the world. For market authorization, comprehensive chemistry, manufacturing and control (CMC) information is required to assure the safety and quality consistency of mRNA vaccines. Evaluating mRNA vaccines for new virus variants poses a challenge for regulators, given the...
Source: Biologicals : Journal of the International Association of Biological Standardization - September 14, 2023 Category: Biotechnology Authors: Jiaqi Lu Wei Wei Wu He Source Type: research

Regulatory perspective for quality evaluation of lipid nanoparticle-based mRNA vaccines in China
Biologicals. 2023 Sep 12;84:101700. doi: 10.1016/j.biologicals.2023.101700. Online ahead of print.ABSTRACTIn recent years, urgent unmet medical needs due to the COVID-19 pandemic have accelerated the application of mRNA technology in vaccine development, leading to some of the first approvals of mRNA vaccines in human history by regulatory agencies around the world. For market authorization, comprehensive chemistry, manufacturing and control (CMC) information is required to assure the safety and quality consistency of mRNA vaccines. Evaluating mRNA vaccines for new virus variants poses a challenge for regulators, given the...
Source: Biologicals : Journal of the International Association of Biological Standardization - September 14, 2023 Category: Biotechnology Authors: Jiaqi Lu Wei Wei Wu He Source Type: research

Regulatory perspective for quality evaluation of lipid nanoparticle-based mRNA vaccines in China
Biologicals. 2023 Sep 12;84:101700. doi: 10.1016/j.biologicals.2023.101700. Online ahead of print.ABSTRACTIn recent years, urgent unmet medical needs due to the COVID-19 pandemic have accelerated the application of mRNA technology in vaccine development, leading to some of the first approvals of mRNA vaccines in human history by regulatory agencies around the world. For market authorization, comprehensive chemistry, manufacturing and control (CMC) information is required to assure the safety and quality consistency of mRNA vaccines. Evaluating mRNA vaccines for new virus variants poses a challenge for regulators, given the...
Source: Biologicals : Journal of the International Association of Biological Standardization - September 14, 2023 Category: Biotechnology Authors: Jiaqi Lu Wei Wei Wu He Source Type: research

Regulatory perspective for quality evaluation of lipid nanoparticle-based mRNA vaccines in China
Biologicals. 2023 Sep 12;84:101700. doi: 10.1016/j.biologicals.2023.101700. Online ahead of print.ABSTRACTIn recent years, urgent unmet medical needs due to the COVID-19 pandemic have accelerated the application of mRNA technology in vaccine development, leading to some of the first approvals of mRNA vaccines in human history by regulatory agencies around the world. For market authorization, comprehensive chemistry, manufacturing and control (CMC) information is required to assure the safety and quality consistency of mRNA vaccines. Evaluating mRNA vaccines for new virus variants poses a challenge for regulators, given the...
Source: Biologicals : Journal of the International Association of Biological Standardization - September 14, 2023 Category: Biotechnology Authors: Jiaqi Lu Wei Wei Wu He Source Type: research

Regulatory perspective for quality evaluation of lipid nanoparticle-based mRNA vaccines in China
Biologicals. 2023 Sep 12;84:101700. doi: 10.1016/j.biologicals.2023.101700. Online ahead of print.ABSTRACTIn recent years, urgent unmet medical needs due to the COVID-19 pandemic have accelerated the application of mRNA technology in vaccine development, leading to some of the first approvals of mRNA vaccines in human history by regulatory agencies around the world. For market authorization, comprehensive chemistry, manufacturing and control (CMC) information is required to assure the safety and quality consistency of mRNA vaccines. Evaluating mRNA vaccines for new virus variants poses a challenge for regulators, given the...
Source: Biologicals : Journal of the International Association of Biological Standardization - September 14, 2023 Category: Biotechnology Authors: Jiaqi Lu Wei Wei Wu He Source Type: research

Regulatory perspective for quality evaluation of lipid nanoparticle-based mRNA vaccines in China
Biologicals. 2023 Sep 12;84:101700. doi: 10.1016/j.biologicals.2023.101700. Online ahead of print.ABSTRACTIn recent years, urgent unmet medical needs due to the COVID-19 pandemic have accelerated the application of mRNA technology in vaccine development, leading to some of the first approvals of mRNA vaccines in human history by regulatory agencies around the world. For market authorization, comprehensive chemistry, manufacturing and control (CMC) information is required to assure the safety and quality consistency of mRNA vaccines. Evaluating mRNA vaccines for new virus variants poses a challenge for regulators, given the...
Source: Biologicals : Journal of the International Association of Biological Standardization - September 14, 2023 Category: Biotechnology Authors: Jiaqi Lu Wei Wei Wu He Source Type: research

Regulatory perspective for quality evaluation of lipid nanoparticle-based mRNA vaccines in China
Biologicals. 2023 Sep 12;84:101700. doi: 10.1016/j.biologicals.2023.101700. Online ahead of print.ABSTRACTIn recent years, urgent unmet medical needs due to the COVID-19 pandemic have accelerated the application of mRNA technology in vaccine development, leading to some of the first approvals of mRNA vaccines in human history by regulatory agencies around the world. For market authorization, comprehensive chemistry, manufacturing and control (CMC) information is required to assure the safety and quality consistency of mRNA vaccines. Evaluating mRNA vaccines for new virus variants poses a challenge for regulators, given the...
Source: Biologicals : Journal of the International Association of Biological Standardization - September 14, 2023 Category: Biotechnology Authors: Jiaqi Lu Wei Wei Wu He Source Type: research