Journal of pharmaceutical sciences最新文献

{"title":"Corrigendum to “Eliminating liquid chromatography-induced methionine oxidation of monoclonal antibodies using high-concentration TCEP injections: The “anTCEPtic” column cleaning method” [Journal of Pharmaceutical Sciences Volume 115, Issue 6, June 2026, 104298]","authors":"Andrew Kleinberg, Joy Yoon, Yuan Mao, Ning Li","doi":"10.1016/j.xphs.2026.104344","DOIUrl":"10.1016/j.xphs.2026.104344","url":null,"abstract":"","PeriodicalId":16741,"journal":{"name":"Journal of pharmaceutical sciences","volume":"115 9","pages":"Article 104344"},"PeriodicalIF":3.9,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149025261","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reply to comments on “Comprehensive stress study on recombinant adeno-associated virus vectors: Evaluating the capabilities of established analytical techniques”","authors":"Jakob Heckel, Lukas Bongers, David Naylor, Ole Schmidt, Raphael Ruppert, Marco Thomann, Florian Semmelmann, Angie Kirchner, Alexandra H.E. Machado, Markus Haindl, Michael Leiss, Jürgen Hubbuch, Tobias Graf","doi":"10.1016/j.xphs.2026.104354","DOIUrl":"10.1016/j.xphs.2026.104354","url":null,"abstract":"","PeriodicalId":16741,"journal":{"name":"Journal of pharmaceutical sciences","volume":"115 9","pages":"Article 104354"},"PeriodicalIF":3.9,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148194914","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Response to comment on “A quantitative metric of immune responses with applications in vaccines, cancer immunity, autoimmunity, and anti-drug antibody monitoring”","authors":"Indiwari Gopallawa, Surendra Chavan, Arvind Goswami, Vibha Jawa, Narendra Chirmule","doi":"10.1016/j.xphs.2026.104331","DOIUrl":"10.1016/j.xphs.2026.104331","url":null,"abstract":"","PeriodicalId":16741,"journal":{"name":"Journal of pharmaceutical sciences","volume":"115 9","pages":"Article 104331"},"PeriodicalIF":3.9,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147963977","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comment from Ailani et al on “Comprehensive stress study on recombinant adeno-associated virus vectors: Evaluating the capabilities of established analytical techniques”","authors":"Tanmay Ailani, Reenoo Jauhari, Anjna Rani, Rajesh Singh","doi":"10.1016/j.xphs.2026.104352","DOIUrl":"10.1016/j.xphs.2026.104352","url":null,"abstract":"","PeriodicalId":16741,"journal":{"name":"Journal of pharmaceutical sciences","volume":"115 9","pages":"Article 104352"},"PeriodicalIF":3.9,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148194866","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reply to comment on “Multidisciplinary exploratory survey: Initial insights into biologic drug handling and regulatory perspectives among healthcare professionals”","authors":"Mattias Paulsson, Lara Nonis, Stanley Kwok","doi":"10.1016/j.xphs.2026.104343","DOIUrl":"10.1016/j.xphs.2026.104343","url":null,"abstract":"","PeriodicalId":16741,"journal":{"name":"Journal of pharmaceutical sciences","volume":"115 9","pages":"Article 104343"},"PeriodicalIF":3.9,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148005614","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Response to the letter regarding “nano-enabled targeted transdermal therapy for pain management in cervical cancer”","authors":"Beatrice Odei-Mensah, Samson A Adeyemi, Yahya Essop Choonara","doi":"10.1016/j.xphs.2026.104422","DOIUrl":"10.1016/j.xphs.2026.104422","url":null,"abstract":"","PeriodicalId":16741,"journal":{"name":"Journal of pharmaceutical sciences","volume":"115 9","pages":"Article 104422"},"PeriodicalIF":3.9,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148471277","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reply letter to original letter: Comment on \"Identifying and mitigating risks during biologic drug product manufacturing: A case study using computational fluid dynamics\".","authors":"Sheetal Pai-Wechsung, James Morgan Harris, Fawziya Ali, Parag Kolhe, Advait Badkar","doi":"10.1016/j.xphs.2026.104463","DOIUrl":"10.1016/j.xphs.2026.104463","url":null,"abstract":"","PeriodicalId":16741,"journal":{"name":"Journal of pharmaceutical sciences","volume":" ","pages":"104463"},"PeriodicalIF":3.9,"publicationDate":"2026-08-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148794672","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comment on \"Identifying and Mitigating Risks During Biologic Drug Product Manufacturing: A Case Study Using Computational Fluid Dynamics\".","authors":"Shaik Mohammed Yusuf, Md Abdul Sattar, Ravichandra Sharabu","doi":"10.1016/j.xphs.2026.104462","DOIUrl":"https://doi.org/10.1016/j.xphs.2026.104462","url":null,"abstract":"","PeriodicalId":16741,"journal":{"name":"Journal of pharmaceutical sciences","volume":" ","pages":"104462"},"PeriodicalIF":3.9,"publicationDate":"2026-08-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148794582","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Biophysical investigations into the impact of crystallization conditions on monoclonal antibody properties and purification.","authors":"Divya Chandra, Sanjeev Agarwal, Siddhi Patel, Sunitha Kandula","doi":"10.1016/j.xphs.2026.104459","DOIUrl":"10.1016/j.xphs.2026.104459","url":null,"abstract":"<p><p>Crystallization of monoclonal antibodies (mAbs) is a challenging problem given their large size and inherent structural complexity. Thousands of conditions need to be screened to arrive at a promising crystallization hit. Historically, crystallization has been successfully applied for preparative-scale purification and manufacturing of small molecules but rarely to produce mAbs, large globular proteins and peptides other than insulins. There is tremendous interest in the biopharmaceutical industry in exploring and implementing alternative strategies for the purification of biologics. One such non-platform, unit operation is crystallization. However, translatability across scales, robustness and amenability for large-scale processing are key challenges that need to be overcome to realize the success of crystallization as a unit operation in biomanufacturing. In this work, we take a biophysical characterization- driven approach to 1) elucidate differences between two unique crystallization conditions, previously identified via high-throughput screening, for a IgG4 mAb, and 2) demonstrate that the fundamental understanding generated from this biophysical characterization can enable a rational selection of crystallization conditions for bioprocessing applications. Results show that the crystallization conditions, both of which crystallize the mAb in two unique crystal structures, can impact the mAb structure and solution-state biophysical properties quite differently leading to significantly different outcomes in thermal and colloidal stability of the protein as well as in the purification of the mAb via crystallization as a unit operation. Second, this work highlights that co-crystallization of a large macromolecule like a mAb with a small molecule like caffeine can dramatically influence solution stability as well as impurity rejection. Third, and related to above we demonstrate that not all crystallization conditions that lead to structure elucidation are amenable for bioprocessing, as certain solution conditions can negatively impact protein solution stability and conformation, impurity co-precipitation thereby leading to lower impurity clearance from complex bioprocess feeds. For bioprocessing applications it is therefore critical to understand the impact of a condition on not just the pure mAb but also on the mAb in complex solutions alongside impurities.</p>","PeriodicalId":16741,"journal":{"name":"Journal of pharmaceutical sciences","volume":" ","pages":"104459"},"PeriodicalIF":3.9,"publicationDate":"2026-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148721928","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Editorial Advisory Board","authors":"","doi":"10.1016/S0022-3549(26)00258-3","DOIUrl":"10.1016/S0022-3549(26)00258-3","url":null,"abstract":"","PeriodicalId":16741,"journal":{"name":"Journal of pharmaceutical sciences","volume":"115 8","pages":"Article 104409"},"PeriodicalIF":3.9,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148935122","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}