{"doi":"10.3389/fddev.2022.1043756","title":"Lyophilization process engineering and thermostability of ID93 + GLA-SE, a single-vial adjuvanted subunit tuberculosis vaccine candidate for use in clinical studies","abstract":"Promising clinical efficacy results have generated considerable enthusiasm for the potential impact of adjuvant-containing subunit tuberculosis vaccines. The development of a thermostable tuberculosis vaccine formulation could have significant benefits on both the cost and feasibility of global vaccine distribution. The tuberculosis vaccine candidate ID93 + GLA-SE has reached Phase 2 clinical testing, demonstrating safety and immunogenicity as a two-vial point-of-care mixture. Earlier publications have detailed efforts to develop a lead candidate single-vial lyophilized thermostable ID93 + GLA-SE vaccine formulation. The present report describes the lyophilization process development and scale-up of the lead candidate thermostable ID93 + GLA-SE composition. The manufacture of three full-scale engineering batches was followed by one batch made and released under current Good Manufacturing Practices (cGMP). Up to 4.5 years of stability data were collected. The cGMP lyophilized ID93 + GLA-SE passed all manufacturing release test criteria and maintained stability for at least 3 months when stored at 37°C and up to 24 months when stored at 5°C. This work represents the first advancement of a thermostable adjuvant-containing subunit tuberculosis vaccine to clinical testing readiness.","journal":"Frontiers in Drug Delivery","year":2022,"id":278958,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":6,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.955,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2022-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":322166,"name":"Michelle Archer","orcid":null,"position":1,"is_corresponding":false},{"id":321236,"name":"Joseph McCollum","orcid":"0000-0002-8104-4755","position":2,"is_corresponding":false},{"id":322167,"name":"Chris Press","orcid":null,"position":3,"is_corresponding":false},{"id":951959,"name":"L.C. McNeill","orcid":"0000-0002-8689-5882","position":4,"is_corresponding":false},{"id":952577,"name":"Linda Hawkins","orcid":null,"position":5,"is_corresponding":false},{"id":448557,"name":"Tony Phan","orcid":null,"position":6,"is_corresponding":false},{"id":448559,"name":"Erik D. Laursen","orcid":null,"position":7,"is_corresponding":false},{"id":951806,"name":"Richard Cabullos","orcid":null,"position":8,"is_corresponding":false},{"id":952578,"name":"Lisa Bouchard","orcid":null,"position":9,"is_corresponding":false},{"id":952579,"name":"Regie J. Castro","orcid":null,"position":10,"is_corresponding":false},{"id":952580,"name":"Mong-Wu Lin","orcid":null,"position":11,"is_corresponding":false},{"id":952581,"name":"Jeralyn Roco","orcid":null,"position":12,"is_corresponding":false},{"id":952582,"name":"Cecile Blois","orcid":null,"position":13,"is_corresponding":false},{"id":951960,"name":"Babatunde Ayodeji Adeagbo","orcid":"0000-0002-6722-1970","position":14,"is_corresponding":false},{"id":745239,"name":"Jeffrey A. Guderian","orcid":null,"position":15,"is_corresponding":false},{"id":321242,"name":"Alana Gerhardt","orcid":"0000-0001-6753-7134","position":16,"is_corresponding":false},{"id":952583,"name":"Anna Marie Beckmann","orcid":null,"position":17,"is_corresponding":false},{"id":952584,"name":"Edward H. Trappler","orcid":null,"position":18,"is_corresponding":false},{"id":321243,"name":"Ryan M. Kramer","orcid":"0000-0002-2749-5301","position":19,"is_corresponding":false},{"id":258353,"name":"Christopher B. Fox","orcid":"0000-0002-4644-2619","position":20,"is_corresponding":false},{"id":952576,"name":"Timothy S. Dutill","orcid":null,"position":0,"is_corresponding":true}],"reference_count":26,"raw_metadata":null,"created_at":"2026-07-19T00:28:51.322666Z","pmid":"37771324","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}