{"doi":"10.3390/pharmaceutics16060742","title":"Use of Transient Transfection for cGMP Manufacturing of eOD-GT8 60mer, a Self-Assembling Nanoparticle Germline-Targeting HIV-1 Vaccine Candidate","abstract":"We describe the current Good Manufacturing Practice (cGMP) production and subsequent characterization of eOD-GT8 60mer, a glycosylated self-assembling nanoparticle HIV-1 vaccine candidate and germline targeting priming immunogen. Production was carried out via transient expression in the human embryonic kidney 293 (HEK293) cell line followed by a combination of purification techniques. A large-scale cGMP (200 L) production run yielded 354 mg of the purified eOD-GT8 60mer drug product material, which was formulated at 1 mg/mL in 10% sucrose in phosphate-buffered saline (PBS) at pH 7.2. The clinical trial material was comprehensively characterized for purity, antigenicity, glycan composition, amino acid sequence, and aggregation and by several safety-related tests during cGMP lot release. A comparison of the purified products produced at the 1 L scale and 200 L cGMP scale demonstrated the consistency and robustness of the transient transfection upstream process and the downstream purification strategies. The cGMP clinical trial material was tested in a Phase 1 clinical trial (NCT03547245), is currently being stored at -80 °C, and is on a stability testing program as per regulatory guidelines. The methods described here illustrate the utility of transient transfection for cGMP production of complex products such as glycosylated self-assembling nanoparticles.","journal":"Pharmaceutics","year":2024,"id":438471,"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":10,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9551,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2024-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":236277,"name":"Sergey Menis","orcid":"0000-0002-2487-5413","position":1,"is_corresponding":false},{"id":994000,"name":"Evan T. Brower","orcid":null,"position":2,"is_corresponding":false},{"id":923113,"name":"Eddy Sayeed","orcid":null,"position":3,"is_corresponding":false},{"id":994001,"name":"Jim Ackland","orcid":null,"position":4,"is_corresponding":false},{"id":993496,"name":"Angela Lombardo","orcid":"0000-0003-0182-133X","position":5,"is_corresponding":false},{"id":279923,"name":"Christopher A. Cottrell","orcid":null,"position":6,"is_corresponding":false},{"id":106545,"name":"Jonathan L. Torres","orcid":"0000-0003-0137-8497","position":7,"is_corresponding":false},{"id":994002,"name":"Thomas M. Hassell","orcid":null,"position":8,"is_corresponding":false},{"id":230082,"name":"Andrew B. Ward","orcid":"0000-0001-7153-3769","position":9,"is_corresponding":false},{"id":993495,"name":"Vadim Tsvetnitsky","orcid":"0000-0002-7103-473X","position":10,"is_corresponding":false},{"id":236279,"name":"William R. Schief","orcid":"0000-0002-1120-0150","position":11,"is_corresponding":false},{"id":993494,"name":"Vaneet K. Sharma","orcid":"0000-0001-6322-2055","position":0,"is_corresponding":true}],"reference_count":53,"raw_metadata":null,"created_at":"2026-07-19T02:00:38.888629Z","pmid":"38931864","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":[]}