{"id":"https://openalex.org/W4383760468","doi":"https://doi.org/10.1371/journal.pone.0284198","title":"Analytical comparability to evaluate impact of manufacturing changes of ARX788, an Anti-HER2 ADC in late-stage clinical development","display_name":"Analytical comparability to evaluate impact of manufacturing changes of ARX788, an Anti-HER2 ADC in late-stage clinical development","publication_year":2023,"publication_date":"2023-07-10","ids":{"openalex":"https://openalex.org/W4383760468","doi":"https://doi.org/10.1371/journal.pone.0284198","pmid":"https://pubmed.ncbi.nlm.nih.gov/37428761","pmcid":"https://www.ncbi.nlm.nih.gov/pmc/articles/10332591"},"language":"en","primary_location":{"id":"doi:10.1371/journal.pone.0284198","doi":"https://doi.org/10.1371/journal.pone.0284198","is_oa":true,"landing_page_url":"https://doi.org/10.1371/journal.pone.0284198","pdf_url":"https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0284198&type=printable","source":{"id":"https://openalex.org/S202381698","display_name":"PLoS ONE","issn_l":"1932-6203","issn":["1932-6203"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["anvur-class-a","anvur-scientific","cwts-core","doaj","dongbi-c","doyens","erih-plus","jufo-1","ki-jl-1","medline","norway-1","poland-100","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310315706","host_organization_name":"Public Library of Science","host_organization_lineage":["https://openalex.org/P4310315706"],"host_organization_lineage_names":["Public Library of Science"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"PLOS ONE","raw_type":"journal-article"},"volume":null,"type":"article","indexed_in":["crossref","doaj","pubmed"],"open_access":{"is_oa":true,"oa_status":"gold","oa_url":"https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0284198&type=printable","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5112787279","display_name":"Wayne K. Yu","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210107392","display_name":"Ambrx (United States)","ror":"https://ror.org/01r1pft76","country_code":"US","type":"company","lineage":["https://openalex.org/I4210107392"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Wayne Yu","raw_affiliation_strings":["Ambrx Incorporated, 10975 North Torrey Pines Road, La Jolla, CA 92037, USA","Ambrx Incorporated, La Jolla, CA, United States of America"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Ambrx Incorporated, 10975 North Torrey Pines Road, La Jolla, CA 92037, USA","institution_ids":["https://openalex.org/I4210107392"]},{"raw_affiliation_string":"Ambrx Incorporated, La Jolla, CA, United States of America","institution_ids":["https://openalex.org/I4210107392"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5057242938","display_name":"Mysore P. Ramprasad","orcid":"https://orcid.org/0009-0000-5001-1013","observed_orcids":["https://orcid.org/0009-0000-5001-1013"]},"institutions":[{"id":"https://openalex.org/I4210107392","display_name":"Ambrx (United States)","ror":"https://ror.org/01r1pft76","country_code":"US","type":"company","lineage":["https://openalex.org/I4210107392"]}],"countries":["US"],"is_corresponding":true,"raw_author_name":"Mysore Ramprasad","raw_affiliation_strings":["Ambrx Incorporated, 10975 North Torrey Pines Road, La Jolla, CA 92037, USA","Ambrx Incorporated, La Jolla, CA, United States of America"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Ambrx Incorporated, 10975 North Torrey Pines Road, La Jolla, CA 92037, USA","institution_ids":["https://openalex.org/I4210107392"]},{"raw_affiliation_string":"Ambrx Incorporated, La Jolla, CA, United States of America","institution_ids":["https://openalex.org/I4210107392"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5065954633","display_name":"Manoj  Kumar Pal","orcid":"https://orcid.org/0000-0001-9152-1028","observed_orcids":["https://orcid.org/0000-0001-9152-1028"]},"institutions":[{"id":"https://openalex.org/I4210107392","display_name":"Ambrx (United States)","ror":"https://ror.org/01r1pft76","country_code":"US","type":"company","lineage":["https://openalex.org/I4210107392"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Manoj Pal","raw_affiliation_strings":["Ambrx Incorporated, 10975 North Torrey Pines Road, La Jolla, CA 92037, USA","Ambrx Incorporated, La Jolla, CA, United States of America"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Ambrx Incorporated, 10975 North Torrey Pines Road, La Jolla, CA 92037, USA","institution_ids":["https://openalex.org/I4210107392"]},{"raw_affiliation_string":"Ambrx Incorporated, La Jolla, CA, United States of America","institution_ids":["https://openalex.org/I4210107392"]}]},{"author_position":"middle","author":{"id":null,"display_name":"Chris Chen","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210107392","display_name":"Ambrx (United States)","ror":"https://ror.org/01r1pft76","country_code":"US","type":"company","lineage":["https://openalex.org/I4210107392"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Chris Chen","raw_affiliation_strings":["Ambrx Incorporated, 10975 North Torrey Pines Road, La Jolla, CA 92037, USA","Ambrx Incorporated, La Jolla, CA, United States of America"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Ambrx Incorporated, 10975 North Torrey Pines Road, La Jolla, CA 92037, USA","institution_ids":["https://openalex.org/I4210107392"]},{"raw_affiliation_string":"Ambrx Incorporated, La Jolla, CA, United States of America","institution_ids":["https://openalex.org/I4210107392"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5063017131","display_name":"Shashi Paruchuri","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210107392","display_name":"Ambrx (United States)","ror":"https://ror.org/01r1pft76","country_code":"US","type":"company","lineage":["https://openalex.org/I4210107392"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Shashi Paruchuri","raw_affiliation_strings":["Ambrx Incorporated, 10975 North Torrey Pines Road, La Jolla, CA 92037, USA","Ambrx Incorporated, La Jolla, CA, United States of America"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Ambrx Incorporated, 10975 North Torrey Pines Road, La Jolla, CA 92037, USA","institution_ids":["https://openalex.org/I4210107392"]},{"raw_affiliation_string":"Ambrx Incorporated, La Jolla, CA, United States of America","institution_ids":["https://openalex.org/I4210107392"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5034466570","display_name":"Lillian K. Skidmore","orcid":"https://orcid.org/0009-0005-8277-8223","observed_orcids":["https://orcid.org/0009-0005-8277-8223"]},"institutions":[{"id":"https://openalex.org/I4210107392","display_name":"Ambrx (United States)","ror":"https://ror.org/01r1pft76","country_code":"US","type":"company","lineage":["https://openalex.org/I4210107392"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Lillian Skidmore","raw_affiliation_strings":["Ambrx Incorporated, 10975 North Torrey Pines Road, La Jolla, CA 92037, USA","Ambrx Incorporated, La Jolla, CA, United States of America"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Ambrx Incorporated, 10975 North Torrey Pines Road, La Jolla, CA 92037, USA","institution_ids":["https://openalex.org/I4210107392"]},{"raw_affiliation_string":"Ambrx Incorporated, La Jolla, CA, United States of America","institution_ids":["https://openalex.org/I4210107392"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5031305401","display_name":"Nick A. Knudsen","orcid":"https://orcid.org/0009-0004-7026-0366","observed_orcids":["https://orcid.org/0009-0004-7026-0366"]},"institutions":[{"id":"https://openalex.org/I4210107392","display_name":"Ambrx (United States)","ror":"https://ror.org/01r1pft76","country_code":"US","type":"company","lineage":["https://openalex.org/I4210107392"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Nick Knudsen","raw_affiliation_strings":["Ambrx Incorporated, 10975 North Torrey Pines Road, La Jolla, CA 92037, USA","Ambrx Incorporated, La Jolla, CA, United States of America"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Ambrx Incorporated, 10975 North Torrey Pines Road, La Jolla, CA 92037, USA","institution_ids":["https://openalex.org/I4210107392"]},{"raw_affiliation_string":"Ambrx Incorporated, La Jolla, CA, United States of America","institution_ids":["https://openalex.org/I4210107392"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5040343042","display_name":"Molly Allen","orcid":"https://orcid.org/0000-0002-2419-0000","observed_orcids":["https://orcid.org/0000-0002-2419-0000"]},"institutions":[{"id":"https://openalex.org/I4210107392","display_name":"Ambrx (United States)","ror":"https://ror.org/01r1pft76","country_code":"US","type":"company","lineage":["https://openalex.org/I4210107392"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Molly Allen","raw_affiliation_strings":["Ambrx Incorporated, 10975 North Torrey Pines Road, La Jolla, CA 92037, USA","Ambrx Incorporated, La Jolla, CA, United States of America"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Ambrx Incorporated, 10975 North Torrey Pines Road, La Jolla, CA 92037, USA","institution_ids":["https://openalex.org/I4210107392"]},{"raw_affiliation_string":"Ambrx Incorporated, La Jolla, CA, United States of America","institution_ids":["https://openalex.org/I4210107392"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5026631878","display_name":"Ying Ji Buechler","orcid":"https://orcid.org/0009-0002-3117-0929","observed_orcids":["https://orcid.org/0009-0002-3117-0929"]},"institutions":[{"id":"https://openalex.org/I4210107392","display_name":"Ambrx (United States)","ror":"https://ror.org/01r1pft76","country_code":"US","type":"company","lineage":["https://openalex.org/I4210107392"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Ying Buechler","raw_affiliation_strings":["Ambrx Incorporated, 10975 North Torrey Pines Road, La Jolla, CA 92037, USA","Ambrx Incorporated, La Jolla, CA, United States of America"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Ambrx Incorporated, 10975 North Torrey Pines Road, La Jolla, CA 92037, USA","institution_ids":["https://openalex.org/I4210107392"]},{"raw_affiliation_string":"Ambrx Incorporated, La Jolla, CA, United States of America","institution_ids":["https://openalex.org/I4210107392"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":1,"corresponding_author_ids":["https://openalex.org/A5057242938"],"corresponding_institution_ids":["https://openalex.org/I4210107392"],"apc_list":{"value":1805,"currency":"USD","value_usd":1805},"apc_paid":{"value":1805,"currency":"USD","value_usd":1805},"fwci":1.0906,"has_fulltext":true,"cited_by_count":10,"citation_normalized_percentile":{"value":0.74430816,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":89,"max":99},"biblio":{"volume":"18","issue":"7","first_page":"e0284198","last_page":"e0284198"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T12255","display_name":"Biosimilars and Bioanalytical Methods","score":0.8682000041007996,"subfield":{"id":"https://openalex.org/subfields/2403","display_name":"Immunology"},"field":{"id":"https://openalex.org/fields/24","display_name":"Immunology and Microbiology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},"topics":[{"id":"https://openalex.org/T12255","display_name":"Biosimilars and Bioanalytical Methods","score":0.8682000041007996,"subfield":{"id":"https://openalex.org/subfields/2403","display_name":"Immunology"},"field":{"id":"https://openalex.org/fields/24","display_name":"Immunology and Microbiology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},{"id":"https://openalex.org/T11124","display_name":"Protein purification and stability","score":0.10639999806880951,"subfield":{"id":"https://openalex.org/subfields/1312","display_name":"Molecular Biology"},"field":{"id":"https://openalex.org/fields/13","display_name":"Biochemistry, Genetics and Molecular Biology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},{"id":"https://openalex.org/T11460","display_name":"Analytical Methods in Pharmaceuticals","score":0.005900000222027302,"subfield":{"id":"https://openalex.org/subfields/1602","display_name":"Analytical Chemistry"},"field":{"id":"https://openalex.org/fields/16","display_name":"Chemistry"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/antibody-drug-conjugates","display_name":"antibody-drug conjugates","score":0.8659999966621399},{"id":"https://openalex.org/keywords/her2","display_name":"HER2","score":0.7620000243186951},{"id":"https://openalex.org/keywords/comparability","display_name":"comparability","score":0.5479999780654907},{"id":"https://openalex.org/keywords/drug-substances","display_name":"drug substances","score":0.6209999918937683},{"id":"https://openalex.org/keywords/drug-products","display_name":"drug products","score":0.9940000176429749},{"id":"https://openalex.org/keywords/quality-risk-assessment","display_name":"quality risk assessment","score":0.5019999742507935},{"id":"https://openalex.org/keywords/forced-degradation","display_name":"forced degradation","score":0.6830000281333923},{"id":"https://openalex.org/keywords/physicochemical-characterization","display_name":"physicochemical characterization","score":0.8899999856948853},{"id":"https://openalex.org/keywords/biological-characterization","display_name":"biological characterization","score":0.6930000185966492}],"concepts":[{"id":"https://openalex.org/C2780449318","wikidata":"https://www.wikidata.org/wiki/Q18344773","display_name":"Critical quality attributes","level":3,"score":0.6107289791107178},{"id":"https://openalex.org/C197947376","wikidata":"https://www.wikidata.org/wiki/Q5155608","display_name":"Comparability","level":2,"score":0.5877917408943176},{"id":"https://openalex.org/C2780035454","wikidata":"https://www.wikidata.org/wiki/Q8386","display_name":"Drug","level":2,"score":0.5706124305725098},{"id":"https://openalex.org/C204320433","wikidata":"https://www.wikidata.org/wiki/Q7268772","display_name":"Quality by Design","level":3,"score":0.5258520245552063},{"id":"https://openalex.org/C2987875673","wikidata":"https://www.wikidata.org/wiki/Q187939","display_name":"Manufacturing process","level":2,"score":0.5219523310661316},{"id":"https://openalex.org/C64903051","wikidata":"https://www.wikidata.org/wiki/Q2198549","display_name":"Drug development","level":3,"score":0.48234838247299194},{"id":"https://openalex.org/C19351080","wikidata":"https://www.wikidata.org/wiki/Q1395034","display_name":"New product development","level":2,"score":0.38190731406211853},{"id":"https://openalex.org/C183696295","wikidata":"https://www.wikidata.org/wiki/Q2487696","display_name":"Biochemical engineering","level":1,"score":0.3605985641479492},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.3561835289001465},{"id":"https://openalex.org/C98274493","wikidata":"https://www.wikidata.org/wiki/Q128406","display_name":"Pharmacology","level":1,"score":0.3528759479522705},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.3386628031730652},{"id":"https://openalex.org/C192562407","wikidata":"https://www.wikidata.org/wiki/Q228736","display_name":"Materials science","level":0,"score":0.20302480459213257},{"id":"https://openalex.org/C144133560","wikidata":"https://www.wikidata.org/wiki/Q4830453","display_name":"Business","level":0,"score":0.18704146146774292},{"id":"https://openalex.org/C127413603","wikidata":"https://www.wikidata.org/wiki/Q11023","display_name":"Engineering","level":0,"score":0.16619369387626648},{"id":"https://openalex.org/C33923547","wikidata":"https://www.wikidata.org/wiki/Q395","display_name":"Mathematics","level":0,"score":0.13779452443122864},{"id":"https://openalex.org/C162853370","wikidata":"https://www.wikidata.org/wiki/Q39809","display_name":"Marketing","level":1,"score":0.0},{"id":"https://openalex.org/C159985019","wikidata":"https://www.wikidata.org/wiki/Q181790","display_name":"Composite material","level":1,"score":0.0},{"id":"https://openalex.org/C114614502","wikidata":"https://www.wikidata.org/wiki/Q76592","display_name":"Combinatorics","level":1,"score":0.0}],"mesh":[{"descriptor_ui":"D000911","descriptor_name":"Antibodies, Monoclonal","qualifier_ui":"Q000737","qualifier_name":"chemistry","is_major_topic":false},{"descriptor_ui":"D000970","descriptor_name":"Antineoplastic Agents","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D009842","descriptor_name":"Oligopeptides","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D018796","descriptor_name":"Immunoconjugates","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true}],"locations_count":5,"locations":[{"id":"doi:10.1371/journal.pone.0284198","doi":"https://doi.org/10.1371/journal.pone.0284198","is_oa":true,"landing_page_url":"https://doi.org/10.1371/journal.pone.0284198","pdf_url":"https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0284198&type=printable","source":{"id":"https://openalex.org/S202381698","display_name":"PLoS ONE","issn_l":"1932-6203","issn":["1932-6203"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["anvur-class-a","anvur-scientific","cwts-core","doaj","dongbi-c","doyens","erih-plus","jufo-1","ki-jl-1","medline","norway-1","poland-100","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310315706","host_organization_name":"Public Library of Science","host_organization_lineage":["https://openalex.org/P4310315706"],"host_organization_lineage_names":["Public Library of Science"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"PLOS ONE","raw_type":"journal-article"},{"id":"doi:10.1101/2023.03.27.534450","doi":"https://doi.org/10.1101/2023.03.27.534450","is_oa":true,"landing_page_url":"http://dx.doi.org/10.1101/2023.03.27.534450","pdf_url":"https://www.biorxiv.org/content/biorxiv/early/2023/03/29/2023.03.27.534450.full.pdf","source":{"id":"https://openalex.org/S4306402567","display_name":"bioRxiv (Cold Spring Harbor Laboratory)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I2750212522","host_organization_name":"Cold Spring Harbor Laboratory","host_organization_lineage":["https://openalex.org/I2750212522"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"acceptedVersion","is_accepted":true,"is_published":false,"raw_source_name":"bioRxiv","raw_type":"posted-content"},{"id":"pmh:oai:pubmedcentral.nih.gov:10332591","doi":null,"is_oa":true,"landing_page_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/10332591","pdf_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC10332591/pdf/pone.0284198.pdf","source":{"id":"https://openalex.org/S2764455111","display_name":"PubMed Central","issn_l":null,"issn":null,"is_oa":true,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"PLoS One","raw_type":"Text"},{"id":"pmid:37428761","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/37428761","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"PloS one","raw_type":"Journal Article"},{"id":"pmh:oai:doaj.org/article:eb9db323b041430e80c926d72bc97f6f","doi":null,"is_oa":true,"landing_page_url":"https://doaj.org/article/eb9db323b041430e80c926d72bc97f6f","pdf_url":null,"source":{"id":"https://openalex.org/S4306401280","display_name":"DOAJ (DOAJ: Directory of Open Access Journals)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by-sa","license_id":"https://openalex.org/licenses/cc-by-sa","version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"PLoS ONE, Vol 18, Iss 7, p e0284198 (2023)","raw_type":"article"}],"best_oa_location":{"id":"doi:10.1371/journal.pone.0284198","doi":"https://doi.org/10.1371/journal.pone.0284198","is_oa":true,"landing_page_url":"https://doi.org/10.1371/journal.pone.0284198","pdf_url":"https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0284198&type=printable","source":{"id":"https://openalex.org/S202381698","display_name":"PLoS ONE","issn_l":"1932-6203","issn":["1932-6203"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["anvur-class-a","anvur-scientific","cwts-core","doaj","dongbi-c","doyens","erih-plus","jufo-1","ki-jl-1","medline","norway-1","poland-100","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310315706","host_organization_name":"Public Library of Science","host_organization_lineage":["https://openalex.org/P4310315706"],"host_organization_lineage_names":["Public Library of Science"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"PLOS ONE","raw_type":"journal-article"},"sustainable_development_goals":[{"id":"https://metadata.un.org/sdg/3","display_name":"Good health and well-being","score":0.504800021648407}],"study_designs":[],"awards":[],"funders":[],"has_content":{"grobid_xml":true,"pdf":true},"content_urls":{"pdf":"https://content.openalex.org/works/W4383760468.pdf","grobid_xml":"https://content.openalex.org/works/W4383760468.grobid-xml"},"referenced_works_count":17,"referenced_works":["https://openalex.org/W2024969564","https://openalex.org/W2071163127","https://openalex.org/W2234950698","https://openalex.org/W2328510303","https://openalex.org/W2751949649","https://openalex.org/W2791987218","https://openalex.org/W2911417699","https://openalex.org/W2965356307","https://openalex.org/W2969830246","https://openalex.org/W3017076641","https://openalex.org/W3034156764","https://openalex.org/W3042830787","https://openalex.org/W3187784120","https://openalex.org/W4282932052","https://openalex.org/W4297929256","https://openalex.org/W4308444914","https://openalex.org/W4309331280"],"related_works":["https://openalex.org/W3042830787","https://openalex.org/W1651223554","https://openalex.org/W3034156764","https://openalex.org/W3006062562","https://openalex.org/W7213334523","https://openalex.org/W4241112262","https://openalex.org/W4387810047","https://openalex.org/W4417189930","https://openalex.org/W4392718532","https://openalex.org/W7213933152"],"abstract_inverted_index":{"ARX788":[0,20,45,91],"is":[1],"an":[2],"anti-HER2":[3],"antibody":[4],"drug":[5,46,49,92,96],"conjugate":[6],"(ADC)":[7],"developed":[8],"using":[9],"Ambrx":[10],"proprietary":[11],"Engineered":[12],"Precision":[13],"Biologics":[14],"technology.":[15],"The":[16],"manufacturing":[17,103],"process":[18,43,102],"of":[19,27,36,63,84],"has":[21],"been":[22],"optimized":[23],"during":[24],"the":[25,87,101],"course":[26],"early":[28],"to":[29],"late-phase":[30],"clinical":[31],"development.":[32],"A":[33],"comprehensive":[34],"evaluation":[35],"side-by-side":[37],"comparability":[38],"between":[39,86],"pre-":[40,88],"and":[41,48,68,73,89,95],"post-change":[42,90],"for":[44],"substance":[47,93],"product":[50,97,108],"from":[51],"a":[52,81],"quality":[53],"perspective":[54],"was":[55],"conducted":[56],"based":[57],"on":[58],"ICH":[59],"Q5E":[60],"guidelines":[61],"consisting":[62],"batch":[64],"release":[65],"assays,":[66],"physicochemical":[67],"biophysical":[69],"characterization,":[70,72],"biological":[71],"forced":[74],"degradation":[75],"studies.":[76],"All":[77],"results":[78],"have":[79],"substantiated":[80],"high":[82],"degree":[83],"similarity":[85],"batches":[94],"lots,":[98],"demonstrating":[99],"that":[100],"changes":[104],"did":[105],"not":[106],"impact":[107],"quality.":[109]},"counts_by_year":[{"year":2026,"cited_by_count":6},{"year":2025,"cited_by_count":1},{"year":2024,"cited_by_count":2},{"year":2023,"cited_by_count":1}],"updated_date":"2026-10-31T12:09:11.096373","created_date":"2023-07-11T00:00:00"}