PDA Journal of Pharmaceutical Science and Technology最新文献_第2页

Understanding Alignment in the Execution of Extractable Screening Studies Between Laboratories: Results of the ELSIE Lab Practices Sub-Team Industry Surveys. 理解在实验室之间执行可提取筛选研究的一致性：ELSIE实验室实践子团队行业调查的结果。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2025-03-03 DOI: 10.5731/pdajpst.2024.012964

Steven A Zdravkovic, Qiang Fu, Aaron Flick, Bhargava Jana, Elizabeth Looney, Samuel Kikandi, Tim Verdonck, Lee Nagao, Mary Kate Bielinski

{"title":"Understanding Alignment in the Execution of Extractable Screening Studies Between Laboratories: Results of the ELSIE Lab Practices Sub-Team Industry Surveys.","authors":"Steven A Zdravkovic, Qiang Fu, Aaron Flick, Bhargava Jana, Elizabeth Looney, Samuel Kikandi, Tim Verdonck, Lee Nagao, Mary Kate Bielinski","doi":"10.5731/pdajpst.2024.012964","DOIUrl":"https://doi.org/10.5731/pdajpst.2024.012964","url":null,"abstract":"Substances that can be extracted (extractables) from the components of a medical device or a pharmaceutical product's manufacturing, packaging, and/or delivery system(s) are characterized as part of an extractable screening study to ensure the safety of the associated therapy. While the requirements of such studies have been established on a strategic level, the tactical approaches for their execution are less controlled, and as such, have been established on a laboratory-by-laboratory basis. Based on anecdotal accounts, differences in these tactical variables have resulted in inconsistent data obtained between laboratories when all other factors are equal. To better understand this potential issue, the Lab Practices Working Group within the Extractable & Leachable Safety Information Exchange (ELSIE) has conducted two surveys of the practices used by several pharmaceutical sponsors and contract research organizations for their execution of extractable screening studies. The results obtained from these surveys uncovered a lack of alignment in some experimental variables for the execution of these studies including selection and use of surrogate standard(s), establishment of system suitability, qualification of screening methods, and use of uncertainty factors. Accordingly, it was concluded that the potential exists for at least some differences in the data obtained from extractable screening studies between laboratories due to the inconsistencies in their execution uncovered in these surveys.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"79 1","pages":"4-27"},"PeriodicalIF":0.0,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143542964","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

Addressing Medical Device Extractables and Leachables via Non-Target Analysis (NTA); The Analytical Evaluation Threshold (AET) and Quantitation. 通过非目标分析（NTA）处理医疗器械可提取物和可浸出物分析评价阈值（AET）与定量。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2025-03-03 DOI: 10.5731/pdajpst.2024.012945

Dennis Jenke, Piet Christiaens, Ted Heise

{"title":"Addressing Medical Device Extractables and Leachables via Non-Target Analysis (NTA); The Analytical Evaluation Threshold (AET) and Quantitation.","authors":"Dennis Jenke, Piet Christiaens, Ted Heise","doi":"10.5731/pdajpst.2024.012945","DOIUrl":"10.5731/pdajpst.2024.012945","url":null,"abstract":"Substances leached from a medical device during its clinical use are important due to the patient health-related effects they may have. Thus, medical devices are profiled for leachables (and/or extractables as probable leachables) by screening extracts or leachates of the medical device for released organic substances via a non-target analysis (NTA) employing chromatographic methods coupled with mass spectrometric detection. Chromatographic mass spectral response factors for extractables and leachables vary significantly from compound to compound, complicating the application of assessment strategies such as the analytical evaluation threshold (AET), which is the concentration threshold at or above which an extractable or leachable must be reported for quantitative toxicological risk assessment. The analytical uncertainty resulting from response variation can make interpretation of the AET difficult, potentially leading to both false positive and false negative outcomes. Furthermore, response factor variation complicates the estimation of leachables' and extractables' concentrations (quantification). This Correspondence discusses practices for the calculation and application of the AET and for performing quantification, including a discussion of accuracy versus protectiveness.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":" ","pages":"98-113"},"PeriodicalIF":0.0,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142896699","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

A Risk Assessment and Risk Based Approach Review of Pre-use/Post Sterilization Integrity Testing (PUPSIT).

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2025-02-10 DOI: 10.5731/pdajpst.2024.003038

Kelly Waldron, Amanda McFarland, Hal Baseman, Maik Jornitz

{"title":"A Risk Assessment and Risk Based Approach Review of Pre-use/Post Sterilization Integrity Testing (PUPSIT).","authors":"Kelly Waldron, Amanda McFarland, Hal Baseman, Maik Jornitz","doi":"10.5731/pdajpst.2024.003038","DOIUrl":"https://doi.org/10.5731/pdajpst.2024.003038","url":null,"abstract":"In January 2023, ICHQ9 was updated to include expanded guidance on risk-based decision-making, emphasizing its application in informing science-driven and strategic decisions. The revised guidance highlights that while quality risk management can aid decision-making, it does not eliminate the industry's obligation to comply with regulatory requirements. This article introduces a framework for evaluating the risks and benefits of pre-use/post-sterilization integrity testing (PUPSIT) using risk management principles. It provides a structured approach to assess the acceptability of alternative methods to the EU Annex 1 PUPSIT requirement, which acknowledges that PUPSIT may not always be feasible due to constraints such as the filtration of small solution volumes. In such cases, Annex 1 permits alternative approaches if a comprehensive risk assessment is conducted and effective controls are implemented to mitigate the risk of non-integral filtration systems. The proposed framework considers three critical domainspatient safety, process integrity, and regulatory complianceto ensure decisions are well-informed and balanced. By applying this science- and risk-based approach, organizations can navigate PUPSIT requirements effectively, ensuring compliance while addressing operational limitations.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143391542","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

Case Study: Visual Inspection of Topical Ophthalmic Formulations Packaged in Opaque and Semi-Transparent Containers: Working towards alignment with USP<790> Visible Inspection of Injections.

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2025-02-10 DOI: 10.5731/pdajpst.2024.003017

Mary Lee Ciolkowski, Ann T Davis, Alexa Harding, Stacey M Platzer

{"title":"Case Study: Visual Inspection of Topical Ophthalmic Formulations Packaged in Opaque and Semi-Transparent Containers: Working towards alignment with USP<790> Visible Inspection of Injections.","authors":"Mary Lee Ciolkowski, Ann T Davis, Alexa Harding, Stacey M Platzer","doi":"10.5731/pdajpst.2024.003017","DOIUrl":"https://doi.org/10.5731/pdajpst.2024.003017","url":null,"abstract":"Topical ophthalmic solutions, suspensions, and emulsions are typically packaged in opaque or semi-transparent plastic dropper bottles. This packaging provides resistance to breakage and controlled drop size needed in ophthalmic container systems. Recent changes to general chapter USP<771> Ophthalmic Products - Quality Tests have impacted the particulate and foreign matter testing requirements for ophthalmic products dosed via topical application. The USP<771> chapter instructs that topical products undergo visual inspection for particulate matter as described in general chapter USP<790> Visible Particulates in Injections Visual inspection for particulates in the filled unit is not feasible due to lack of package transparency and therefore alternative test strategies are needed to evaluate the acceptability of the batch. Aspects of this visual inspection approach include: a statistically based sampling plan for the batch, a destructive testing process and acceptance limits based on manufacturing process capability supported with benchmark testing of competitor products to confirm manufacturing performance. Overall, the visual inspection program should include: historical trending; process monitoring; and upstream lifecycle controls for facilities, raw materials, components, and product contact equipment to meet current regulatory expectations and good manufacturing practices.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143391546","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

Meaningful & Measurable Risk Assessment Tools for Environmental Monitoring Site Selection Program. 环境监测选址方案中有意义和可测量的风险评估工具。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2024-12-26 DOI: 10.5731/pdajpst.2024.99908

Vanessa Vasadi Figueroa

{"title":"Meaningful & Measurable Risk Assessment Tools for Environmental Monitoring Site Selection Program.","authors":"Vanessa Vasadi Figueroa","doi":"10.5731/pdajpst.2024.99908","DOIUrl":"https://doi.org/10.5731/pdajpst.2024.99908","url":null,"abstract":"The role of Environmental Monitoring has evolved alongside the manufacturing processes and filling technologies its aims to monitor, and so should the risk assessment tools we implement for establishing this important program. Sample site selection, appropriateness of sampling methods, sampling volumes and sampling frequencies are all important components of contamination control for a facility and must be evaluated as appropriate using a robust risk assessment. The types of environmental monitoring required for a robust program will vary based on the type of operation, frequency in which that operation is performed, and the level of risk associated to the process. Learn how to develop a meaningful risk assessment and include measurable risk rankings for 6 applicable categories in biopharmaceutical manufacturing. The process for scoring each of the 6 categories, systematic evaluation of contamination probability and example outcomes will be shared for theoretical EM sites mapped throughout an ISO 5 and 7 cleanroom area, thus ensuring adequate criteria and fair assessment are applied in each case. The methodology for this risk assessment tool will be demonstrated as suitable for environmental monitoring programs during initial site qualification, when evaluating EMPQ results, or when periodically updating the requirements for monitoring during routine operations.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"78 6","pages":"765-766"},"PeriodicalIF":0.0,"publicationDate":"2024-12-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142895438","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

Contamination Control Strategy (CCS), Check! Now What? Lifecycle Management of CCS. 污染控制策略（CCS），检查！现在怎么办呢?CCS的生命周期管理。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2024-12-26 DOI: 10.5731/pdajpst.2024.99901

Hilary Chan

引用次数: 0

Happy Holidays! 节日快乐!

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2024-12-26 DOI: 10.5731/pdajpst.2024.001846

引用次数: 0

Replacing Traditional Aseptic Process Simulations with Qualification of Cell and Gene Therapy (CGT) Supernatant. 用细胞和基因治疗（CGT）上清鉴定取代传统无菌过程模拟。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2024-12-26 DOI: 10.5731/pdajpst.2024.99910

Bernardo Perez, Johanna O'Bannon

{"title":"Replacing Traditional Aseptic Process Simulations with Qualification of Cell and Gene Therapy (CGT) Supernatant.","authors":"Bernardo Perez, Johanna O'Bannon","doi":"10.5731/pdajpst.2024.99910","DOIUrl":"https://doi.org/10.5731/pdajpst.2024.99910","url":null,"abstract":"Aseptic process simulations (APS) are traditionally performed using Tryptic Soy Broth (TSB) as a surrogate for finished product to qualify aseptic manufacturing operations. In this study, the supernatant from cell processing media was examined for bacterial and fungal growth viability to determine equivalency with TSB. With the use of cell processing media in Cell and Gene Therapy (CGT) manufacturing, can qualifying the supernatant collected from the process eliminate the need for an APS run?Supernatant was collected from cell processing media and incubated at same incubations conditions required for the APS post sterility check (Test A - 7d 20-25°C/7d 30-35°C) and at use conditions (Test B - 14 d at 35°C/5%CO/5%O2). Post incubation, growth promotion testing was performed using ATCC cultures (Ab+, Bs+, Ca+, Ec+, Sa+, Pa+ and Se+), which resulted in growth for Tests A-B and the positive inoculum control. Results concluded that the cell processing supernatant examined was equivalent to TSB, thereby implying that each cell therapy manufacturing run is aseptically self-validating. As more practical approaches emerge for APS qualifications in CGT manufacturing, this data can be used to implement alternate options to qualify a CGT manufacturing process and help establish guidelines for future cell therapy APS qualifications.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"78 6","pages":"769-770"},"PeriodicalIF":0.0,"publicationDate":"2024-12-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142896267","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

Case Studies on Changes and Proposed Process Development Approaches Reflecting Applicability of PDA Technical Report No. 89: Strategies for Vaccine Development and Lifecycle Management. 关于变化和拟议工艺开发方法的案例研究，反映了 PDA 第 89 号技术报告《疫苗开发和生命周期管理战略》的适用性。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2024-12-26 DOI: 10.5731/pdajpst.2024.012976

Cristiana Campa, Didier ClÉnet, Jane Halpern, Lyne Le Palaire, Mahesh Krishnan, Mic McGoldrick, Mihai Bilanin, Priyabrata Pattnaik, Richard Pelt, Sabrina Restrepo

{"title":"Case Studies on Changes and Proposed Process Development Approaches Reflecting Applicability of PDA Technical Report No. 89: Strategies for Vaccine Development and Lifecycle Management.","authors":"Cristiana Campa, Didier ClÉnet, Jane Halpern, Lyne Le Palaire, Mahesh Krishnan, Mic McGoldrick, Mihai Bilanin, Priyabrata Pattnaik, Richard Pelt, Sabrina Restrepo","doi":"10.5731/pdajpst.2024.012976","DOIUrl":"10.5731/pdajpst.2024.012976","url":null,"abstract":"Vaccines are complex and a very diverse group of products with relatively long product life cycles. The manufacturing programs for these vaccines need to be continually updated to comply with evolving regulatory expectations. Members of the Parenteral Drug Association (PDA) Vaccines Interest Group (VIG) authored and published PDA Technical Report No. 89: Strategies for Vaccine Development and Lifecycle Management (TR 89), which seeks to provide context to vaccine developers and manufacturers regarding key aspects of new or legacy vaccines such as control strategy from process development to vaccine life cycle management, comparability and life cycle management including technical, validation, quality, and regulatory perspectives. To further explain and illustrate the concepts and topics discussed, seven relevant situations were selected as either case studies associated with changes implemented or proposed process development strategies, which are discussed in this article. The situations described are: working cell bank, modification or update of externally supplied product contact components for vaccine manufacturing, raw material change, new product at an existing site, vaccine development acceleration by leveraging existing platforms, selection and implementation of potency method, and modeling for stability forecast prediction. For each situation, the applicable key concepts from TR 89 are discussed as follows: Control Strategy, Prior Knowledge, Relying on Pharmaceutical Quality System (PQS), Classification of Parameters, Validation Approach, Use of a Risk-Based Approach, Comparability, Use of ICH Q12, and Additional Regulatory Considerations.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":" ","pages":"735-750"},"PeriodicalIF":0.0,"publicationDate":"2024-12-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142351780","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

Comparing Container Closure Integrity Test Methods-Performance of Headspace Carbon Dioxide Analysis versus Helium Leakage Using Positive Controls. 容器封闭完整性测试方法比较 - 使用阳性对照进行顶空二氧化碳分析与氦气泄漏的性能比较。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2024-12-26 DOI: 10.5731/pdajpst.2023.012881

Christian Proff, Ken Victor, Allison Alix Caudill, Jirakan Nunkaew, Gemma AlmatÓ Bellavista, Holger RÖhl, James Veale

{"title":"Comparing Container Closure Integrity Test Methods-Performance of Headspace Carbon Dioxide Analysis versus Helium Leakage Using Positive Controls.","authors":"Christian Proff, Ken Victor, Allison Alix Caudill, Jirakan Nunkaew, Gemma AlmatÓ Bellavista, Holger RÖhl, James Veale","doi":"10.5731/pdajpst.2023.012881","DOIUrl":"10.5731/pdajpst.2023.012881","url":null,"abstract":"As described in USP <1207>, the deterministic leak test methods using laser-based gas headspace analysis and helium leakage are those with the highest sensitivities. As stated in the chapter, \"no single package leak test or package seal quality test method is applicable to all product-package systems\"; therefore, knowing the advantages and disadvantages of both of these techniques, and the extent to which they can be substituted for each other, is valuable. In an effort to begin addressing this issue, a systematic study using these two techniques has been performed. This study used the same well-defined positive controls prepared with microcapillaries for both measurement techniques. For the headspace gas analysis technique, the headspace carbon dioxide content was measured at multiple time points during three separate conditioning cycles using either a 0.5, 1.0, or 2.0 bar CO2 overpressure; the observed change in headspace carbon dioxide was then used to determine an ingress rate for each positive control. For the helium leakage technique, the positive controls were measured with a standard helium leak detector with 100% helium atmosphere on the atmospheric pressure side of the artificial defects. The resulting leakage rates from both techniques were compared for ingress into both ISO 2 R and ISO 10 R vials. The obtained correlation between helium and carbon dioxide leakage rates resulted in a minimum R2 coefficient of 0.98 across all 12 runs. Additionally, both setups met the acceptance criteria for accuracy with their respective calibrated standards.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":" ","pages":"681-698"},"PeriodicalIF":0.0,"publicationDate":"2024-12-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141760229","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