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Report on the seventh meeting of national control laboratories for vaccines and biologicals of the WHO Western Pacific and South-East Asia member states
Biologicals. 2023 Oct 3;84:101712. doi: 10.1016/j.biologicals.2023.101712. Online ahead of print.ABSTRACTThe Biregional Network of National Control Laboratories (NCLs) of the WHO Western Pacific and South-East Asia Regions has been meeting annually since 2018 to enhance NCLs' voluntary participation capacity. Its seventh meeting was hosted by the Korea National Institute of Food and Drug Safety Evaluation (NIFDS) of the Ministry of Food and Drug Safety (MFDS), in conjunction with the Global Bio Conference, in Seoul on September 6, 2022. Over 60 participants from seven countries, (India, Indonesia, Japan, Korea, Malaysia, t...
Source: Biologicals : Journal of the International Association of Biological Standardization - October 5, 2023 Category: Biotechnology Authors: Sun Bo Shim Chan Woong Choi Jin Ho Shin Jong Won Kim Silke Schepelmann Jae Ho Jung Harish Chander Ratih Pujilestari Madoka Kuramitsu Masaki Ochiai Nee Yuan Qi Geraldine N Dimapilis Luu Thi Dung Hyung Sil Moon In Soo Shin Source Type: research

In silico discovery of epitopes of gag and env proteins for the development of a multi-epitope vaccine candidate against Maedi Visna Virus using reverse vaccinology approach
In conclusion, the gag protein was a better antigen. However, both proteins had epitopes with high antigenicity value. Also, the final multi-epitope vaccine construct had a potential to be used as a peptide vaccine due to its immuno-informatics results.PMID:37793308 | DOI:10.1016/j.biologicals.2023.101715 (Source: Biologicals : Journal of the International Association of Biological Standardization)
Source: Biologicals : Journal of the International Association of Biological Standardization - October 4, 2023 Category: Biotechnology Authors: Ecem Su Ko çkaya H üseyin Can Yal çın Yaman Cemal Ün Source Type: research

Risk assessment for biopharmaceutical single-use manufacturing: A case study of upstream continuous processing
Biologicals. 2023 Oct 2;84:101713. doi: 10.1016/j.biologicals.2023.101713. Online ahead of print.ABSTRACTIn the current transition to intensified upstream processing, the risks of adopting traditional single-use systems for high-titer, long-duration perfusion cultures, have thus far not been considered. This case study uses the Failure Modes and Effects Analysis (FMEA) method to evaluate the risks associated with implementing upstream single-use technology. The simulated model process was used to compare the risk level of single-use technology for a traditional fed-batch cell culture with that for perfusion culture, under ...
Source: Biologicals : Journal of the International Association of Biological Standardization - October 4, 2023 Category: Biotechnology Authors: Takao Ito Hui Wang Soon-Hwa Hwang Bin Wang Lizhi Wang Somasundaram G 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