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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
Proceedings of the 2023 Viral Clearance Symposium, Session 6: Viral Inactivation. 2023 年病毒清除研讨会论文集，第 6 单元：病毒灭活。
PDA Journal of Pharmaceutical Science and Technology Pub Date : 2024-03-01 DOI: 10.5731/pdajpst.2024.002246
Junfen Ma, David Roush
{"title":"Proceedings of the 2023 Viral Clearance Symposium, Session 6: Viral Inactivation.","authors":"Junfen Ma, David Roush","doi":"10.5731/pdajpst.2024.002246","DOIUrl":"https://doi.org/10.5731/pdajpst.2024.002246","url":null,"abstract":"<p><p>The use of detergents or low pH hold are commonly employed techniques in biologics downstream processing to inactivate enveloped viruses. These approaches have been demonstrated to be robust and are detailed in ASTM E2888 (low pH) and ASTM E3042-16 (Triton X-100), accordingly. One of the recent challenges is the need for a replacement of Triton X-100 with a more environmentally friendly detergent with similar log10 reduction value (LRV) achieved. The presentations in this session focused on a detailed assessment of a range of detergents. The most well characterized and potentially robust detergents identified were TDAO (n-Tetradecyl-N,N-dimethylamine-N-oxide) and Simulsol SL 11 W. Key performance factors assessed (in direct comparison with the industry standard Triton X-100) were viral inactivation kinetics (total elapsed time to achieve equilibrium), LRV achieved of enveloped viruses, toxicity, potential impact on product quality and process performance, clearance of residual detergent in subsequent downstream steps, assays to support assessment with appropriate limit of quantification, and commercial supply of detergent of the appropriate quality standard. Both TDAO and Simulsol SL11 had similar overall LRV as Triton-100. In addition, for the low pH viral inactivation, reduced LRV was observed at pH > 3.70 and low salt concentration (outside of the ASTM range), which is a cautionary note when applying low pH inactivation to labile proteins.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"78 2","pages":"187-195"},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140855729","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 8: Cell Banks, Advanced Technologies (ATMPs, NGS). 2023 年病毒清除研讨会论文集》，会议 8：细胞库、先进技术（ATMP、NGS）。
PDA Journal of Pharmaceutical Science and Technology Pub Date : 2024-03-01 DOI: 10.5731/pdajpst.2024.002248
Johanna Kindermann, Thomas R Kreil
{"title":"Proceedings of the 2023 Viral Clearance Symposium, Session 8: Cell Banks, Advanced Technologies (ATMPs, NGS).","authors":"Johanna Kindermann, Thomas R Kreil","doi":"10.5731/pdajpst.2024.002248","DOIUrl":"https://doi.org/10.5731/pdajpst.2024.002248","url":null,"abstract":"<p><p>The Cell Banks, Advanced Technologies (ATMPs, NGS) session at the 2023 Viral Clearance Symposium (VCS) focused on the assurance of high virus safety profiles of advanced technology medicinal products (ATMPs) by implementation of advanced virus detection methods using rapid and sensitive technologies, such as next-generation sequencing (NGS). All presentations in this session made the need to replace in vivo testing for viruses by new technologies that have been demonstrated to be incomparably broad in their detection capabilities and can even detect unknown viruses. An evaluation of historical data collected by the Consortium on Adventitious Agent Contamination in Biomanufacturing (CAACB) from their members' in vivo and in vitro adventitious virus test experience as well as on using NGS was presented. The data convincingly supported the necessity to replace in vivo testing with faster, broader, more sensitive, more accurate, and more specific virus detection methods. Additionally, a collaborative study-initiated by the CAACB-with the goal to revisit traditional adventitious agent testing by using targeted NGS to replace in vivo and in vitro tests for well-known and broadly used Chinese hamster ovary (CHO) cells was presented, including the planned risk-assessment approach using prior knowledge and historical data. Overall, this session demonstrated that the use of new virus detection methods, such as NGS, represents a great opportunity to provide sufficient viral safety margins, specifically, for ATMPs, where downstream virus clearance is not possible. This path forward is also supported by the final ICH Q5A(R2) guideline.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"78 2","pages":"206-211"},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140864697","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 4: Continuous Processing. 2023 年病毒清除研讨会论文集，会议 4：连续处理。
PDA Journal of Pharmaceutical Science and Technology Pub Date : 2024-03-01 DOI: 10.5731/pdajpst.2024.002244
John Fisher, Scott Lute
{"title":"Proceedings of the 2023 Viral Clearance Symposium, Session 4: Continuous Processing.","authors":"John Fisher, Scott Lute","doi":"10.5731/pdajpst.2024.002244","DOIUrl":"https://doi.org/10.5731/pdajpst.2024.002244","url":null,"abstract":"<p><p>The continuous processing session at the 2023 Viral Clearance Symposium (VCS) focused on understanding how to effectively design viral clearance operations for use in continuous processes and methods to perform viral clearance studies. In this session, an approach to directly address control considerations with operating continuous-flow reactors for low pH viral inactivation was presented. Continuous-flow low pH incubation chamber design and implications for residence time determination were discussed. Additionally, viral clearance capability between batch operation and connected operation were demonstrated to be comparable for a connected bind-elute chromatography and flow-through chromatography step. Overall, this session provided additional scientific knowledge to support viral clearance strategies when implementing a continuous manufacturing process.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"78 2","pages":"169-175"},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140861288","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
Leachables analysis from a closed connected single-use mAb purification process 封闭式一次性使用 mAb 纯化工艺的可浸出物分析
PDA Journal of Pharmaceutical Science and Technology Pub Date : 2024-02-22 DOI: 10.5731/pdajpst.2022.012810
Alfred Haglind, Emil Håkansson, Nils Wallménius, Annelie Hansson, Karin Isaksson
{"title":"Leachables analysis from a closed connected single-use mAb purification process","authors":"Alfred Haglind, Emil Håkansson, Nils Wallménius, Annelie Hansson, Karin Isaksson","doi":"10.5731/pdajpst.2022.012810","DOIUrl":"https://doi.org/10.5731/pdajpst.2022.012810","url":null,"abstract":"","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"21 2","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-02-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140439837","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
Development and validation of a customized Amplex UltraRed assay for sensitive hydrogen peroxide detection in pharmaceutical water 开发和验证用于灵敏检测制药用水中过氧化氢的定制 Amplex UltraRed 分析法
PDA Journal of Pharmaceutical Science and Technology Pub Date : 2024-02-22 DOI: 10.5731/pdajpst.2022.012758
A. Heussner, Marlene Hermann, Melanie Zerulla-Wernitz
{"title":"Development and validation of a customized Amplex UltraRed assay for sensitive hydrogen peroxide detection in pharmaceutical water","authors":"A. Heussner, Marlene Hermann, Melanie Zerulla-Wernitz","doi":"10.5731/pdajpst.2022.012758","DOIUrl":"https://doi.org/10.5731/pdajpst.2022.012758","url":null,"abstract":"","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"3 7","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-02-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140441637","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
Correlating GC/MS Relative Response Factors to Analyte′s Physicochemical and Chromatographic Properties to Facilitate the Quantitation of Organic Extractables and Leachables in Non-targeted Analysis (NTA) I. Concepts and Empirical Considerations 将气相色谱/质谱相对响应因子与被分析物的物理化学和色谱特性相关联，以促进非目标分析 (NTA) 中有机萃取物和浸出物的定量 I. 概念和经验考虑因素
PDA Journal of Pharmaceutical Science and Technology Pub Date : 2024-02-22 DOI: 10.5731/pdajpst.2023.012884
Dennis Jenke, Piet Christiaens, Philippe Verlinde, Jan Baeten, J. Beusen
{"title":"Correlating GC/MS Relative Response Factors to Analyte′s Physicochemical and Chromatographic Properties to Facilitate the Quantitation of Organic Extractables and Leachables in Non-targeted Analysis (NTA) I. Concepts and Empirical Considerations","authors":"Dennis Jenke, Piet Christiaens, Philippe Verlinde, Jan Baeten, J. Beusen","doi":"10.5731/pdajpst.2023.012884","DOIUrl":"https://doi.org/10.5731/pdajpst.2023.012884","url":null,"abstract":"","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"6 5","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-02-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140440007","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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