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Artificial Intelligence: Boon or Curse? 人工智能：是福音还是诅咒？
PDA Journal of Pharmaceutical Science and Technology Pub Date : 2024-06-28 DOI: 10.5731/pdajpst.2024.001834
{"title":"Artificial Intelligence: Boon or Curse?","authors":"","doi":"10.5731/pdajpst.2024.001834","DOIUrl":"10.5731/pdajpst.2024.001834","url":null,"abstract":"","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"78 3","pages":"212-213"},"PeriodicalIF":0.0,"publicationDate":"2024-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141470065","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Accurate or Protective: What Is the Goal of Non-Targeted Extractables and Leachables Quantitation and Identification? 准确或保护:非靶向可萃取物和可浸出物定量和鉴定的目标是什么?
PDA Journal of Pharmaceutical Science and Technology Pub Date : 2024-06-28 DOI: 10.5731/pdajpst.2023.012868
Dennis Jenke
{"title":"Accurate or Protective: What Is the Goal of Non-Targeted Extractables and Leachables Quantitation and Identification?","authors":"Dennis Jenke","doi":"10.5731/pdajpst.2023.012868","DOIUrl":"10.5731/pdajpst.2023.012868","url":null,"abstract":"<p><p>Leachables are quantified and identified to enable their quantitative toxicological safety risk assessment (qTSRA). The leachable's reported concentration and identity must meet certain quality expectations to be suitable for qTSRA. In this Correspondence, the author considers accuracy and protectiveness as competing key quality attributes and suggests that protectiveness is the proper quality attribute for qTSRA, as qTSRA is based on the foundation that a leachable's potential adverse effect on patient health and safety must not be underestimated. Considering this conclusion, means of making concentration estimates and proposed identities protective are discussed.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":" ","pages":"358-366"},"PeriodicalIF":0.0,"publicationDate":"2024-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136398656","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Comparison of Binary Alcohol/Water Solvent Systems to Blood for Extractions of Blood-Contacting Medical Devices 二元醇/水溶剂系统与血液的比较，用于提取与血液接触的医疗设备的成分
PDA Journal of Pharmaceutical Science and Technology Pub Date : 2024-04-25 DOI: 10.5731/pdajpst.2023.012892
M. Jordi, Taryn Meade, Kevin Rowland, Chi-hu Ho, Jordan Tocher, Weixi Liu
{"title":"Comparison of Binary Alcohol/Water Solvent Systems to Blood for Extractions of Blood-Contacting Medical Devices","authors":"M. Jordi, Taryn Meade, Kevin Rowland, Chi-hu Ho, Jordan Tocher, Weixi Liu","doi":"10.5731/pdajpst.2023.012892","DOIUrl":"https://doi.org/10.5731/pdajpst.2023.012892","url":null,"abstract":"","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"32 12","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140657571","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Applying Knowledge to Manage Risk - A Case Study in Application of the Risk Knowledge Infinity (RKI) Cycle 应用知识管理风险 - 风险知识无限循环（RKI）应用案例研究
PDA Journal of Pharmaceutical Science and Technology Pub Date : 2024-04-25 DOI: 10.5731/pdajpst.2023.012931
Peer Schmidt, M. Lipa, Jace Fogle, Owen Baker, Timothy Pawlak, Sean McEwen, Kevin O'Donnell
{"title":"Applying Knowledge to Manage Risk - A Case Study in Application of the Risk Knowledge Infinity (RKI) Cycle","authors":"Peer Schmidt, M. Lipa, Jace Fogle, Owen Baker, Timothy Pawlak, Sean McEwen, Kevin O'Donnell","doi":"10.5731/pdajpst.2023.012931","DOIUrl":"https://doi.org/10.5731/pdajpst.2023.012931","url":null,"abstract":"","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"56 15","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140656714","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Proceedings of the 2023 Viral Clearance Symposium: 2023 VCS Summary, Pending Questions, and Next Steps. 2023 年病毒清除研讨会会议记录：2023 年病毒清除研讨会总结、未决问题和下一步行动。
PDA Journal of Pharmaceutical Science and Technology Pub Date : 2024-03-01 DOI: 10.5731/pdajpst.2024.002240
David Roush, Glen Bolton
{"title":"Proceedings of the 2023 Viral Clearance Symposium: 2023 VCS Summary, Pending Questions, and Next Steps.","authors":"David Roush, Glen Bolton","doi":"10.5731/pdajpst.2024.002240","DOIUrl":"https://doi.org/10.5731/pdajpst.2024.002240","url":null,"abstract":"<p><p>The 2023 Viral Clearance Symposium (VCS) was hosted by Takeda on 24 and 25 May 2023 in Vienna, Austria. The present conference extended the structure of the previous biennial symposia held between 2009 and 2019. As recapitulated in the introductory session, the genesis of the VCS, as described in the Proceedings of the 2009 VCS was \"the worldwide regulatory and industry recognition that challenges, gaps, and opportunities exist, that it formally addressed could benefit the field as whole.\" This report provides a synopsis of the progress achieved at the conference resulting from detailed technical discussions and the pending questions that still require attention to address. The 2023 VCS was composed of nine individual sessions of short presentations followed by in-depth panel discussions from the presenters. Sessions included Regulatory Updates (with a focus on ICH Q5A(R2) efforts), including a summary of lessons learned from the 2019 VCS, and progress on these key areas mapped into 2023 VCS topics: Viral Clearance Strategy and Case Studies, New Modalities in Chromatography and Adsorptive Filters, Continuous Processing, Viral Clearance Strategy and Process Understanding, Virus Inactivation, Upstream and Downstream Virus Retentive Filtration and Cell Banks, and Advanced Technologies (advanced therapy medicinal products, next-generation sequencing).</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"78 2","pages":"141-143"},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140868933","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Proceedings of the 2023 Viral Clearance Symposium, Session 3: 2023 VCS New Modalities in Chromatography and Adsorptive Filters. 2023 年病毒清除研讨会论文集，第 3 次会议：2023 年 VCS 色谱和吸附过滤器的新模式。
PDA Journal of Pharmaceutical Science and Technology Pub Date : 2024-03-01 DOI: 10.5731/pdajpst.2024.002243
David Roush, Glen Bolton
{"title":"Proceedings of the 2023 Viral Clearance Symposium, Session 3: 2023 VCS New Modalities in Chromatography and Adsorptive Filters.","authors":"David Roush, Glen Bolton","doi":"10.5731/pdajpst.2024.002243","DOIUrl":"https://doi.org/10.5731/pdajpst.2024.002243","url":null,"abstract":"<p><p>The session provided an update on the application and mechanistic understanding of intensified unit operations (e.g., mixed mode depth filters, mixed mode AEX) since the last conference in 2019. One of the key gaps identified in the 2019 Viral Clearance Symposium session on the topic was for more investigation required to achieve a clear understanding of the molecular mechanisms of virus removal and the relevance of different moleculés interactions including resin, virus, and product. Further investigation into worst-case conditions for these unit operations is also warranted. One of the key outcomes from that 2019 discussion was also that multimodal anion exchangers can have robust and effective virus removal, depending on process and impurities-an observation that was recapitulated with more specific case studies and evidenced by broader application of these chromatographic resins in late-stage regulatory filings.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"78 2","pages":"157-168"},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140850843","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Proceedings of the 2023 Viral Clearance Symposium, Session 2: Viral Clearance Strategy and Case Studies. 2023 年病毒清除研讨会论文集》，会议 2：病毒清除战略与案例研究。
PDA Journal of Pharmaceutical Science and Technology Pub Date : 2024-03-01 DOI: 10.5731/pdajpst.2024.002242
Frank Kohne, Astrid Schwantes
{"title":"Proceedings of the 2023 Viral Clearance Symposium, Session 2: Viral Clearance Strategy and Case Studies.","authors":"Frank Kohne, Astrid Schwantes","doi":"10.5731/pdajpst.2024.002242","DOIUrl":"https://doi.org/10.5731/pdajpst.2024.002242","url":null,"abstract":"<p><p>This session deals with the rational design of viral clearance studies for biopharmaceuticals including recombinant proteins such as monoclonal antibodies and, as new in scope of the symposium, also viral clearance for adeno-associated viral (AAV) vectors. For recombinant proteins, large datasets were accumulated over the last decades and are intended to be used for accelerated product process development and streamlining of viral clearance studies. How to utilize prior knowledge in viral clearance validation and how it can be used in a risk assessment tool to decide whether additional virus clearance studies are necessary during product development is being addressed by three of the presentations of this session. This also includes an a priori intended design and generation of validation data for a new kind of detergent such as CG-110, to build up a platform dataset to be used as prior knowledge in future marketing application. Another presentation investigates the virus removal mechanism of a newly developed hydrophobic interaction chromatography (HIC) resin and demonstrates for highly hydrophobic antibodies appropriate reduction for a retrovirus and impurities in a defined process range in contrast to the moderate to poor virus reduction of recent HIC resins. The last two presentations deal with virus clearance approaches for AAV, which will become mandatory with approval of the ICH Q5A revision. Appropriate virus removal and virus inactivation procedures can be implemented into the manufacturing processes of AAV vectors including viral filtration, viral inactivation (e.g., heat inactivation), affinity chromatography, and anion-exchange chromatography with which it seems possible to achieve a good clearance for helper and also adventitious viruses. The heat treatment step can be even a robust step for adenovirus helper inactivation for AAV products when product characteristics and process conditions are understood.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"78 2","pages":"147-156"},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140868609","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Proceedings of the 2023 Viral Clearance Symposium, Session 5: Viral Clearance Strategy and Process Understanding. 2023 年病毒清除研讨会论文集》，会议 5：病毒清除战略与流程理解。
PDA Journal of Pharmaceutical Science and Technology Pub Date : 2024-03-01 DOI: 10.5731/pdajpst.2024.002245
Kurt Brorson, Sean O'Donnell
{"title":"Proceedings of the 2023 Viral Clearance Symposium, Session 5: Viral Clearance Strategy and Process Understanding.","authors":"Kurt Brorson, Sean O'Donnell","doi":"10.5731/pdajpst.2024.002245","DOIUrl":"https://doi.org/10.5731/pdajpst.2024.002245","url":null,"abstract":"<p><p>Session 5 of the 2023 Viral Clearance Symposium reviewed the strategy and process understanding of viral clearance testing. Topics included learnings from the past, leveraging surrogate-based methodologies, cleaning agents that inactivate enveloped baculoviruses, segregation, and retrovirus-like particles both in continuous process and in-use as spiking viruses. Overall, there were discussions over a wide array of viral clearance determinants.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"78 2","pages":"176-186"},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140867357","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Proceedings of the 2023 Viral Clearance Symposium, Session 7: Up- and Downstream Virus Retentive Filtration. 2023 年病毒清除研讨会论文集，第七场：上游和下游病毒保留过滤。
PDA Journal of Pharmaceutical Science and Technology Pub Date : 2024-03-01 DOI: 10.5731/pdajpst.2024.002247
Xiaoxiang Zhu, Sean O'Donnell
{"title":"Proceedings of the 2023 Viral Clearance Symposium, Session 7: Up- and Downstream Virus Retentive Filtration.","authors":"Xiaoxiang Zhu, Sean O'Donnell","doi":"10.5731/pdajpst.2024.002247","DOIUrl":"https://doi.org/10.5731/pdajpst.2024.002247","url":null,"abstract":"<p><p>Session 7 of the 2023 Viral Clearance Symposium reviewed progresses in virus retentive filtrations applied to both upstream and downstream processing. Upstream topics included investigations and applications of media viral filtration for upstream cell culture viral risk mitigation. Downstream topics included evaluation of viral breakthrough in continuous processing using surrogate particles and demonstration of extensive viral filtration cycling with flow interruptions and long duration in connected process. Reuse of viral filters with proposed procedures was successfully demonstrated amid the supply chain challenge encountered during the pandemic. Discussions and additional considerations for the topics were also provided.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"78 2","pages":"196-205"},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140860203","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Proceedings of the 2023 Viral Clearance Symposium, Session 1: Regulatory Updates. 2023 年病毒清除研讨会论文集，会议 1：法规更新。
PDA Journal of Pharmaceutical Science and Technology Pub Date : 2024-03-01 DOI: 10.5731/pdajpst.2024.002241
Thomas R Kreil
{"title":"Proceedings of the 2023 Viral Clearance Symposium, Session 1: Regulatory Updates.","authors":"Thomas R Kreil","doi":"10.5731/pdajpst.2024.002241","DOIUrl":"https://doi.org/10.5731/pdajpst.2024.002241","url":null,"abstract":"<p><p>At the time of the 2023 Viral Clearance Symposium in Vienna, the ongoing revision of <i>ICH Guideline Q5A(R1) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin</i> clearly was the dominant regulatory topic. At the symposium, the changes expected for Q5A(R2) to mirror advances of scientific knowledge, for example, the inclusion of new products, including viral-vector-derived ones, that can be subject to virus clearance, deliberations around continuous manufacturing processes, the use of prior knowledge to supplement or in part replace virus validation studies, and new molecular methods for detection of adventitious viruses, were discussed by a European and a US regulator as well as representatives from industry associations that had been involved with the drafting process.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"78 2","pages":"144-146"},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140857547","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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