{"id":"https://openalex.org/W7225818530","doi":"https://doi.org/10.18609/cgti.2026.128","title":"Comparative assessment of drug substance frozen storage containers for AAV8 manufacturing","display_name":"Comparative assessment of drug substance frozen storage containers for AAV8 manufacturing","publication_year":2026,"publication_date":"2026-11-11","ids":{"openalex":"https://openalex.org/W7225818530","doi":"https://doi.org/10.18609/cgti.2026.128"},"language":"en","primary_location":{"id":"doi:10.18609/cgti.2026.128","doi":"https://doi.org/10.18609/cgti.2026.128","is_oa":true,"landing_page_url":"https://doi.org/10.18609/cgti.2026.128","pdf_url":null,"source":{"id":"https://openalex.org/S4210198480","display_name":"Cell and Gene Therapy Insights","issn_l":"2059-7800","issn":["2059-7800","2397-0545"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core"],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"journal"},"license":"cc-by-nc-nd","license_id":"https://openalex.org/licenses/cc-by-nc-nd","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Cell and Gene Therapy Insights","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["crossref"],"open_access":{"is_oa":true,"oa_status":"hybrid","oa_url":"https://doi.org/10.18609/cgti.2026.128","any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5161443227","display_name":"Yu-Chieh (Ariel) Chen","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I186523950","display_name":"Regeneron (United States)","ror":"https://ror.org/02f51rf24","country_code":"US","type":"company","lineage":["https://openalex.org/I186523950"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Yu-Chieh (Ariel) Chen","raw_affiliation_strings":["Drug Product Development and Technology, Regeneron Pharmaceuticals, Inc., Tarrytown, New York 10591, United States"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Drug Product Development and Technology, Regeneron Pharmaceuticals, Inc., Tarrytown, New York 10591, United States","institution_ids":["https://openalex.org/I186523950"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5111064591","display_name":"Jonathan Wert","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I186523950","display_name":"Regeneron (United States)","ror":"https://ror.org/02f51rf24","country_code":"US","type":"company","lineage":["https://openalex.org/I186523950"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Jonathan Wert","raw_affiliation_strings":["Drug Product Development and Technology, Regeneron Pharmaceuticals, Inc., Tarrytown, New York 10591, United States"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Drug Product Development and Technology, Regeneron Pharmaceuticals, Inc., Tarrytown, New York 10591, United States","institution_ids":["https://openalex.org/I186523950"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5156320470","display_name":"Kuan-Yu Lai","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I186523950","display_name":"Regeneron (United States)","ror":"https://ror.org/02f51rf24","country_code":"US","type":"company","lineage":["https://openalex.org/I186523950"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Kuan-Yu Lai","raw_affiliation_strings":["Drug Product Development and Technology, Regeneron Pharmaceuticals, Inc., Tarrytown, New York 10591, United States"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Drug Product Development and Technology, Regeneron Pharmaceuticals, Inc., Tarrytown, New York 10591, United States","institution_ids":["https://openalex.org/I186523950"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5028855573","display_name":"Li Zhi","orcid":"https://orcid.org/0009-0004-8317-7385","observed_orcids":["https://orcid.org/0009-0004-8317-7385"]},"institutions":[{"id":"https://openalex.org/I186523950","display_name":"Regeneron (United States)","ror":"https://ror.org/02f51rf24","country_code":"US","type":"company","lineage":["https://openalex.org/I186523950"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Li Zhi","raw_affiliation_strings":["Drug Product Development and Technology, Regeneron Pharmaceuticals, Inc., Tarrytown, New York 10591, United States"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Drug Product Development and Technology, Regeneron Pharmaceuticals, Inc., Tarrytown, New York 10591, United States","institution_ids":["https://openalex.org/I186523950"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5072083189","display_name":"Mohammed Shameem","orcid":"https://orcid.org/0000-0001-7289-8380","observed_orcids":["https://orcid.org/0000-0001-7289-8380"]},"institutions":[{"id":"https://openalex.org/I186523950","display_name":"Regeneron (United States)","ror":"https://ror.org/02f51rf24","country_code":"US","type":"company","lineage":["https://openalex.org/I186523950"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Mohammed Shameem","raw_affiliation_strings":["Drug Product Development and Technology, Regeneron Pharmaceuticals, Inc., Tarrytown, New York 10591, United States"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Drug Product Development and Technology, Regeneron Pharmaceuticals, Inc., Tarrytown, New York 10591, United States","institution_ids":["https://openalex.org/I186523950"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5036143449","display_name":"Dingjiang Liu","orcid":"https://orcid.org/0000-0002-8665-2426","observed_orcids":["https://orcid.org/0000-0002-8665-2426"]},"institutions":[{"id":"https://openalex.org/I186523950","display_name":"Regeneron (United States)","ror":"https://ror.org/02f51rf24","country_code":"US","type":"company","lineage":["https://openalex.org/I186523950"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Dingjiang Liu","raw_affiliation_strings":["Drug Product Development and Technology, Regeneron Pharmaceuticals, Inc., Tarrytown, New York 10591, United States"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Drug Product Development and Technology, Regeneron Pharmaceuticals, Inc., Tarrytown, New York 10591, United States","institution_ids":["https://openalex.org/I186523950"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":1,"corresponding_author_ids":[],"corresponding_institution_ids":["https://openalex.org/I186523950"],"apc_list":null,"apc_paid":null,"fwci":0.0,"has_fulltext":false,"cited_by_count":0,"citation_normalized_percentile":{"value":0.0,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":null,"biblio":{"volume":"12","issue":"10","first_page":"1015","last_page":"1029"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10613","display_name":"Virus-based gene therapy research","score":0.8384000062942505,"subfield":{"id":"https://openalex.org/subfields/1311","display_name":"Genetics"},"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"}},"topics":[{"id":"https://openalex.org/T10613","display_name":"Virus-based gene therapy research","score":0.8384000062942505,"subfield":{"id":"https://openalex.org/subfields/1311","display_name":"Genetics"},"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/T11124","display_name":"Protein purification and stability","score":0.12399999797344208,"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/T11663","display_name":"Viral Infectious Diseases and Gene Expression in Insects","score":0.007300000172108412,"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"}}],"keywords":[],"concepts":[{"id":"https://openalex.org/C18743360","wikidata":"https://www.wikidata.org/wiki/Q1208096","display_name":"Diafiltration","level":4,"score":0.8790000081062317},{"id":"https://openalex.org/C50817676","wikidata":"https://www.wikidata.org/wiki/Q7880534","display_name":"Ultrafiltration (renal)","level":2,"score":0.698199987411499},{"id":"https://openalex.org/C185592680","wikidata":"https://www.wikidata.org/wiki/Q2329","display_name":"Chemistry","level":0,"score":0.6502000093460083},{"id":"https://openalex.org/C43617362","wikidata":"https://www.wikidata.org/wiki/Q170050","display_name":"Chromatography","level":1,"score":0.5601999759674072},{"id":"https://openalex.org/C542903549","wikidata":"https://www.wikidata.org/wiki/Q422248","display_name":"Monoclonal antibody","level":3,"score":0.43389999866485596},{"id":"https://openalex.org/C2779751980","wikidata":"https://www.wikidata.org/wiki/Q143429","display_name":"Polyethylene","level":2,"score":0.421999990940094},{"id":"https://openalex.org/C2780035454","wikidata":"https://www.wikidata.org/wiki/Q8386","display_name":"Drug","level":2,"score":0.4207000136375427},{"id":"https://openalex.org/C84199377","wikidata":"https://www.wikidata.org/wiki/Q723912","display_name":"Freeze-drying","level":2,"score":0.39149999618530273},{"id":"https://openalex.org/C2779820397","wikidata":"https://www.wikidata.org/wiki/Q1392806","display_name":"Drug delivery","level":2,"score":0.35670000314712524},{"id":"https://openalex.org/C40767141","wikidata":"https://www.wikidata.org/wiki/Q285697","display_name":"Recombinant DNA","level":3,"score":0.335099995136261}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.18609/cgti.2026.128","doi":"https://doi.org/10.18609/cgti.2026.128","is_oa":true,"landing_page_url":"https://doi.org/10.18609/cgti.2026.128","pdf_url":null,"source":{"id":"https://openalex.org/S4210198480","display_name":"Cell and Gene Therapy Insights","issn_l":"2059-7800","issn":["2059-7800","2397-0545"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core"],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"journal"},"license":"cc-by-nc-nd","license_id":"https://openalex.org/licenses/cc-by-nc-nd","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Cell and Gene Therapy Insights","raw_type":"journal-article"}],"best_oa_location":{"id":"doi:10.18609/cgti.2026.128","doi":"https://doi.org/10.18609/cgti.2026.128","is_oa":true,"landing_page_url":"https://doi.org/10.18609/cgti.2026.128","pdf_url":null,"source":{"id":"https://openalex.org/S4210198480","display_name":"Cell and Gene Therapy Insights","issn_l":"2059-7800","issn":["2059-7800","2397-0545"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core"],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"journal"},"license":"cc-by-nc-nd","license_id":"https://openalex.org/licenses/cc-by-nc-nd","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Cell and Gene Therapy Insights","raw_type":"journal-article"},"sustainable_development_goals":[],"study_designs":[],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":0,"referenced_works":[],"related_works":[],"abstract_inverted_index":{"Recombinant":[0],"AAV":[1,32,58,113,123],"has":[2,24],"attracted":[3],"significant":[4],"interest,":[5],"especially":[6],"in":[7,144,196,199,213],"recent":[8],"years,":[9],"due":[10,203],"to":[11,26,30,87,103,117,174,184,204],"their":[12,50],"clinical":[13],"success":[14,23],"as":[15,91],"the":[16,60,139,176,200,214,232,237],"optimal":[17],"gene":[18],"therapy":[19],"delivery":[20],"system.":[21],"This":[22,136],"led":[25],"a":[27],"pressing":[28],"need":[29],"accelerate":[31],"production.":[33],"Unlike":[34],"monoclonal":[35],"antibodies":[36],"(mAbs),":[37],"AAVs":[38],"are":[39,52],"protein":[40],"\u2013":[41,99,169],"DNA":[42],"complexes":[43],"that":[44,178],"have":[45],"distinct":[46],"stability":[47,121],"features,":[48],"and":[49,62,66,120,132,154],"bioprocesses":[51],"not":[53],"yet":[54],"fully":[55],"understood.":[56],"During":[57],"manufacturing,":[59],"ultrafiltration":[61],"diafiltration":[63],"(UF/DF)":[64],"pool":[65],"drug":[67,104],"substance":[68],"(DS)":[69],"may":[70,83,181],"be":[71,85,182],"stored":[72,126,198,212],"under":[73,133],"refrigerated":[74],"or":[75,97,172],"frozen":[76,150],"conditions":[77,177],"for":[78,112,149,226],"extended":[79,93,160],"time.":[80],"Additionally,":[81],"they":[82],"also":[84],"subjected":[86],"manufacturing":[88,186],"stresses":[89],"such":[90],"agitation,":[92],"room":[94],"temperature":[95],"hold,":[96],"freeze":[98,168],"thaw":[100,170],"cycles":[101],"prior":[102],"product":[105],"(DP)":[106],"manufacturing.":[107],"Choosing":[108],"suitable":[109],"storage":[110,161],"containers":[111,148],"DS":[114,124,143,180],"is":[115],"crucial":[116],"ensure":[118],"compatibility":[119],"of":[122,141],"when":[125,211],"at":[127,162],"deep-frozen":[128],"temperatures":[129],"(\u2264":[130],"-60\u00b0C)":[131],"stress":[134],"conditions.":[135],"study":[137,191],"evaluated":[138],"performance":[140],"AAV8":[142,179,197,227],"two":[145],"common":[146],"single-use":[147],"storage,":[151],"polyethylene":[152],"(PE)":[153],"ethylene-vinyl":[155],"acetate":[156,205],"(EVA)":[157],"bags,":[158],"after":[159],"-80\u00b0C,":[163],"5\u00b0C":[164],"and/or":[165],"25\u00b0C,":[166],"multiple":[167],"cycles,":[171],"agitation":[173],"mimic":[175],"exposed":[183],"during":[185],"processes.":[187],"Results":[188],"from":[189],"this":[190],"revealed":[192],"acidic":[193],"pH":[194,208,233],"drifts":[195,234],"EVA":[201,238],"bag":[202],"leachable,":[206],"whereas":[207],"remained":[209],"stable":[210],"PE":[215],"bag.":[216,239],"A":[217],"mitigation":[218],"strategy":[219],"was":[220],"developed":[221],"by":[222],"increasing":[223],"buffer":[224],"capacity":[225],"formulations,":[228],"which":[229],"successfully":[230],"stabilized":[231],"associated":[235],"with":[236]},"counts_by_year":[],"updated_date":"2026-11-12T12:28:57.059296","created_date":"2026-11-12T00:00:00"}