{"doi":"10.1002/btpr.3296","title":"Analytical characterization of broadly neutralizing antibody <scp>CAP256LS</scp> heavy chain clipping during manufacturing development","abstract":"Broadly neutralizing antibody (bNAb) CAP256-VRC26.25 (abbreviated CAP256LS), a human IgGI monoclonal antibody targeting the V1V2 site of the HIV-1 envelope, has demonstrated high therapeutic potential as a broadly neutralizing monoclonal antibody against HIV-1. During the process development, a heavy chain fragmentation (clipping) was observed, that led to a relative potency reduction. In this report, we highlighted a series of process and product mitigation strategies deployed to advance this product. We have detailed how analytical characterization tools, especially the microchip reduced capillary gel electrophoresis (CGE-SDS), played a pivotal role in identifying the development issues and in providing measurements to guide implementation of mitigation strategies.","journal":"Biotechnology Progress","year":2022,"id":294650,"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":2,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9425,"is_data_producer":false,"deposit_databanks":null,"is_oa":false,"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":324833,"name":"Erwin Rosales‐Zavala","orcid":null,"position":1,"is_corresponding":false},{"id":324830,"name":"Vera B. Ivleva","orcid":null,"position":2,"is_corresponding":false},{"id":323769,"name":"Yanhong Yang","orcid":"0000-0003-2917-5130","position":3,"is_corresponding":false},{"id":323765,"name":"Yile Li","orcid":"0000-0002-5917-9418","position":4,"is_corresponding":false},{"id":323766,"name":"Sarah O’Connell","orcid":"0000-0002-1645-0722","position":5,"is_corresponding":false},{"id":105605,"name":"Nicole A. Doria‐Rose","orcid":"0000-0002-5731-3054","position":6,"is_corresponding":false},{"id":323767,"name":"Aakash Patel","orcid":"0000-0002-1846-8862","position":7,"is_corresponding":false},{"id":437672,"name":"Daniel Blackstock","orcid":"0000-0002-4056-0673","position":8,"is_corresponding":false},{"id":323764,"name":"Daniel B. Gowetski","orcid":"0000-0003-3946-7751","position":9,"is_corresponding":false},{"id":324820,"name":"Kevin Carlton","orcid":null,"position":10,"is_corresponding":false},{"id":323762,"name":"Jason G. Gall","orcid":"0000-0002-8411-1351","position":11,"is_corresponding":false},{"id":323771,"name":"Q. Paula Lei","orcid":"0000-0002-3656-4014","position":12,"is_corresponding":false},{"id":323763,"name":"Deepika Gollapudi","orcid":"0000-0003-1640-0036","position":0,"is_corresponding":true}],"reference_count":20,"raw_metadata":null,"created_at":"2026-07-19T00:31:01.450041Z","pmid":"36054677","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":[]}