{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Xu G"],"funding":["National Key R&D Program of China"],"pagination":["2005507"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC8726686"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["14(1)"],"pubmed_abstract":["The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has triggered a serious public health crisis worldwide, and considering the novelty of the disease, preventative and therapeutic measures alike are urgently needed. To accelerate such efforts, the development of JS016, a neutralizing monoclonal antibody directed against the SARS-CoV-2 spike protein, was expedited from a typical 12- to 18-month period to a 4-month period. During this process, transient Chinese hamster ovary cell lines are used to support preclinical, investigational new drug-enabling toxicology research, and early Chemistry, Manufacturing and Controls development; mini-pool materials to supply Phase 1 clinical trials; and a single-clone working cell bank for late-stage and pivotal clinical trials "],"journal":["mAbs"],"pubmed_title":["Quality comparability assessment of a SARS-CoV-2-neutralizing antibody across transient, mini-pool-derived and single-clone CHO cells."],"pmcid":["PMC8726686"],"funding_grant_id":["2020YFC0860700"],"pubmed_authors":["Liu H","Duan M","Zhu Y","Fu Z","Guo S","Wu G","Xu G","Li M","Wang L","Li Y","Fu C","Yang Y","Yu C","Cui Y","Feng H","Wang W","Liu C","Du J","Yu X"],"additional_accession":[]},"is_claimable":false,"name":"Quality comparability assessment of a SARS-CoV-2-neutralizing antibody across transient, mini-pool-derived and single-clone CHO cells.","description":"The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has triggered a serious public health crisis worldwide, and considering the novelty of the disease, preventative and therapeutic measures alike are urgently needed. To accelerate such efforts, the development of JS016, a neutralizing monoclonal antibody directed against the SARS-CoV-2 spike protein, was expedited from a typical 12- to 18-month period to a 4-month period. During this process, transient Chinese hamster ovary cell lines are used to support preclinical, investigational new drug-enabling toxicology research, and early Chemistry, Manufacturing and Controls development; mini-pool materials to supply Phase 1 clinical trials; and a single-clone working cell bank for late-stage and pivotal clinical trials ","dates":{"release":"2022-01-01T00:00:00Z","publication":"2022 Jan-Dec","modification":"2025-06-01T02:42:19.451Z","creation":"2025-06-01T02:42:19.451Z"},"accession":"S-EPMC8726686","cross_references":{"pubmed":["34923915"],"doi":["10.1080/19420862.2021.2005507"]}}