PDA Journal of Pharmaceutical Science and Technology最新文献_第5页

Pre-Announced vs. Unannounced FDA Drug Inspections: How Surprise Visits Change Enforcement Outcomes: Poster Presented at PDA Week 2026. 预先宣布与未宣布的FDA药品检查：突击访问如何改变执法结果：2026年PDA周上的海报。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-08-07 DOI: 10.5731/pdajpst.2026.26416

Michael de la Torre, Yelena Ionova, Barry Price

{"title":"Pre-Announced vs. Unannounced FDA Drug Inspections: How Surprise Visits Change Enforcement Outcomes: Poster Presented at PDA Week 2026.","authors":"Michael de la Torre, Yelena Ionova, Barry Price","doi":"10.5731/pdajpst.2026.26416","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26416","url":null,"abstract":"Today's external manufacturing landscape demands more than retrospective audits and subjective traffic-light risk scores. With many CMO and API partners and fragmented oversight processes, quality organizations often discover problems only after they have escalated into supply disruptions or regulatory actions.This session will explore how predictive intelligence can modernize supplier oversight. By unifying structured and unstructured data sources - inspections, deviations, recalls, enforcement documents, audits, batch records, changes - into a single system of intelligence, we can surface early signals of risk. Hazard models and AI-based risk scoring now make it possible to quantify the likelihood of recalls, enforcement actions, or supplier disruptions weeks to months in advance.Real-world use cases will illustrate how large pharma organizations are reducing surprises, better targeting audits, and improving supplier selection decisions. The presentation will highlight the shift from static dashboards to near real-time monitoring, automated alerts, and data-driven next-best-action recommendations.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 4","pages":"490-491"},"PeriodicalIF":0.0,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148689601","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

Adapting Drug Delivery for High-Volume Home Administration: Poster Presented at PDA Week 2026. 适应大批量家庭给药的药物递送：在PDA周2026上发表的海报。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-08-07 DOI: 10.5731/pdajpst.2026.26403

Yitian Xiao, Paolo Ferrigno

{"title":"Adapting Drug Delivery for High-Volume Home Administration: Poster Presented at PDA Week 2026.","authors":"Yitian Xiao, Paolo Ferrigno","doi":"10.5731/pdajpst.2026.26403","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26403","url":null,"abstract":"The rising prevalence of Biologics and other sensitive therapeutics in clinical practice are rapidly modifying the landscape of subcutaneous (SC) drug delivery. Such route of administration empowers patients with the ability to self-administer at home, reducing the burden of frequent clinic visits and supporting the growing shift toward decentralized, patient-centric healthcare.Traditionally, SC injections have been limited to low volumes (typically ≤2 mL) due to concerns over pain, tissue tolerability, and absorption kinetics. However, emerging therapies-particularly monoclonal antibodies, anti-cancer treatments, and long-acting neurologic formulations-often require higher doses that cannot be feasibly delivered subcutaneously within these conventional volume constraints. Consequently, there is a growing demand for innovative solutions supporting self-administration of larger volumes, without compromising safety, therapeutic efficacy and compliance.Sensing such market pressure, Datwyler extended its range of NeoFlex™ plungers to complete larger containers, supporting the novel on-body injectors designed for slow, controlled delivery, expanding the feasible range of SC administration volumes. A collaborative and open approach among the parties involved with the development of the container closure system (CCS) and the device allows the optimization of pre-verified platform solutions, so to accelerate their time to market and, ultimately, availability to patients.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 4","pages":"468-469"},"PeriodicalIF":0.0,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148689696","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

Training under the CSV Microscope: An In-Depth Look at the Impact of Training on ERP System Validation AKA Don't let Finance muddy the waters: Poster Presented at PDA Week 2026. CSV显微镜下的培训：深入了解培训对ERP系统验证的影响又名不要让财务搅浑水：2026年PDA周上的海报。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-08-07 DOI: 10.5731/pdajpst.2026.26436

Prerana Kumar

{"title":"Training under the CSV Microscope: An In-Depth Look at the Impact of Training on ERP System Validation AKA Don't let Finance muddy the waters: Poster Presented at PDA Week 2026.","authors":"Prerana Kumar","doi":"10.5731/pdajpst.2026.26436","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26436","url":null,"abstract":"Effective training is essential in the life sciences industry, to ensure product quality and safety by preventing contamination and errors, meeting regulatory requirements, reducing operational risks, and enhancing overall efficiency.Validation activities for Building, Planning and Logistics platforms like Enterprise Resource Planning (ERP) systems benefit from a careful planning effort to ensure that the approach is well-suited to the diverse users and functional groups accessing the application. As an ERP system includes quality critical and business critical functions, the dynamics of Enterprise-Level Computerized System Validation (CSV) testing must be adapted to address this duality - and training plays a key role.Clearly differentiating the quality critical features from the business-critical features, authoring both detailed and unscripted tests based on quality criticality, and ensuring that functional groups and the test execution team are well trained on the methods of testing can greatly impact the success of your effort and accelerate speed to market.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 4","pages":"520-521"},"PeriodicalIF":0.0,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148689634","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

Debunking Misconceptions and Highlighting Common Denominators and Differences: VHP Sterilization vs. Bio-Decontamination: Poster Presented at PDA Week 2026. 揭穿误解，突出共同点和差异：VHP灭菌与生物去污：PDA周2026上的海报。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-08-07 DOI: 10.5731/pdajpst.2026.26410

Matt Hofacre, Bruno Aze, Juha Mattila, Mary Van Gaasbeck-Carico

{"title":"Debunking Misconceptions and Highlighting Common Denominators and Differences: VHP Sterilization vs. Bio-Decontamination: Poster Presented at PDA Week 2026.","authors":"Matt Hofacre, Bruno Aze, Juha Mattila, Mary Van Gaasbeck-Carico","doi":"10.5731/pdajpst.2026.26410","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26410","url":null,"abstract":"Misconceptions and misleading claims about VH2O2/VHP sterilization and bio-decontamination are increasingly common in today's market. For pharmaceutical and medical device manufacturers, understanding the key differences between the two VH2O2 application methods is essential for successful implementation and regulatory compliance.VH2O2 technologies have been in continuously increasing role for ensuring proper risk assessment and contamination control in pharmaceutical manufacturing processes, especially highlighted by the 2022 revision of EU Annex 1. VHP is specifically important for sensitive drug products manufacturing such as aseptic processing, cleanroom bioburden control and low-temperature terminal surface sterilization of prefilled syringe and other combination products.This presentation will discuss the following topics: Process and technology, applications, pros and cons, implementation, testing and validation of VH2O2 processesRecent regulatory developments for VH2O2 technologiesCommon denominators and differences between VH2O2 sterilization and bio-decontaminationDebunking misconceptions and misleading claimsFuture of VH2O2 technologies in the pharmaceutical and medical device industry.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 4","pages":"480-481"},"PeriodicalIF":0.0,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148689686","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

AI-Powered Automated Visual Inspection of IV Bags: A Real-World Case Study: Poster Presented at PDA Week 2026. 人工智能驱动的静脉输液袋自动视觉检查：一个真实世界的案例研究：在PDA周2026上发表的海报。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-08-07 DOI: 10.5731/pdajpst.2026.26402

Francesco Brazzarola, Luca Vescovi, Beatrice Balboni, Arianna Cella, Alessandro Mazzocchi, Federica Sartori

{"title":"AI-Powered Automated Visual Inspection of IV Bags: A Real-World Case Study: Poster Presented at PDA Week 2026.","authors":"Francesco Brazzarola, Luca Vescovi, Beatrice Balboni, Arianna Cella, Alessandro Mazzocchi, Federica Sartori","doi":"10.5731/pdajpst.2026.26402","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26402","url":null,"abstract":"A high-volume IV bag line with variable printing faced ongoing false rejects, prompting deployment of an AI-powered automated visual inspection (AVI) system from concept to production floor. The AVI system learns to distinguish subtle print artifacts from true particulates in real time, preserving print legibility while reducing misclassifications caused by printing variability, bag deformation, and lighting. The program progressed from concept through design, proof-of-concept testing, scale-up, FAT, SAT, and production qualification and validation. The AVI architecture blends deep learning defect detection with high-quality image capture and integrates with existing MES/packaging controls to gate good product and flag anomalies without slowing throughput. Practical design questions were addressed: camera placement, illumination strategies, data management and labeling, and model training and validation. Regulatory alignment (IQ/OQ/PQ, change control, GMP) underpins lifecycle management for AI-enabled inspection, including retraining and performance monitoring. Real-world learnings cover key design choices, maintenance strategies, and deployment milestones to sustain performance in continuous production. Expected outcomes include lower false rejects, improved detection of particulates on challenging flexible bag formats, and enhanced line efficiency while maintaining compliance.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 4","pages":"466-467"},"PeriodicalIF":0.0,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148689639","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

Toward Radical Transparency: The FDA's New Policy on Public Disclosure of Complete Response Letters and Implications for Regulatory Strategy: Poster Presented at PDA Week 2026. 走向彻底透明：FDA关于公开披露完整答复函的新政策及其对监管策略的影响：2026年PDA周上的海报。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-08-07 DOI: 10.5731/pdajpst.2026.26435

Harpreet Kaur

{"title":"Toward Radical Transparency: The FDA's New Policy on Public Disclosure of Complete Response Letters and Implications for Regulatory Strategy: Poster Presented at PDA Week 2026.","authors":"Harpreet Kaur","doi":"10.5731/pdajpst.2026.26435","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26435","url":null,"abstract":"For the first time in its history, the U.S. Food and Drug Administration (FDA) announced a landmark policy shift aimed at increasing transparency by publicly releasing Complete Response Letters (CRLs) in near real-time, even for applications that are pending, withdrawn, or abandoned. This bold step transforms regulatory transparency and shifts the balance between sponsors, regulators, and the public.The new policy has immediate and far-reaching consequences. For the industry, public disclosure of CRLs will reshape how sponsors approach development planning, regulatory submissions, and external communications. The availability of detailed deficiency letters will allow competitors and new entrants to learn from regulatory precedent, potentially improving submission quality and reducing duplicative errors. At the same time, greater transparency raises essential questions regarding intellectual property protection, reputational risk, and alignment of corporate disclosures with the FDA's regulatory record.For stakeholders-including drug developers, investors, and regulators-this new framework introduces both opportunities and challenges. It promises to enhance regulatory predictability and public trust, while requiring careful recalibration of confidentiality practices and regulatory risk management strategies. This poster will analyze the policy in detail, highlight anticipated impacts on development programs and communication strategies, and discuss the broader implications for regulatory science and industry practice.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 4","pages":"518-519"},"PeriodicalIF":0.0,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148689714","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

Heat Transfer Characteristics of Various Bulk Lyophilization Containers: Poster Presented at PDA Week 2026. 各种散装冻干容器的传热特性：在PDA周2026上发表的海报。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-08-07 DOI: 10.5731/pdajpst.2026.26420

Jason B Angstadt

{"title":"Heat Transfer Characteristics of Various Bulk Lyophilization Containers: Poster Presented at PDA Week 2026.","authors":"Jason B Angstadt","doi":"10.5731/pdajpst.2026.26420","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26420","url":null,"abstract":"Bulk lyophilization requires large amounts of material being filled into a bulk tray. Lyophilization cycle development for a bulk configuration normally requires a large amount of solution, typically several hundred milliliters to several liters, to obtain reproducible, representative freeze-drying results. During early development activities, this volume may not be readily available. To avoid devoting large volumes of material to developing a lyophilization cycle, alternative containers may be used, but these containers should be characterized to understand the different heat transfer characteristics and their effect on the final lyophilization cycle. The purpose of this poster is to develop a method to correlate lyophilization cycle development results between bulk trays and alternative containers and demonstrate the ability to complete bulk lyophilization cycle development on a smaller sample size. The vessels were filled with Purified Water, USP and the cycles were interrupted in primary drying and the vessels removed and weighed. Sublimation rate studies were completed in different containers to determine a correlation between Lyoguard trays and different containers to determine the optimal vessel to do small scale studies and develop lyophilization cycles for bulk products with minimal use of product.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 4","pages":"496-497"},"PeriodicalIF":0.0,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148689535","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

ICH Q9 focused Revision Q9 (R1): Poster Presented at PDA Week 2026. ICH Q9重点修订Q9 (R1)：在PDA周2026上展示的海报。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-08-07 DOI: 10.5731/pdajpst.2026.26429

Aron Yaeger

{"title":"ICH Q9 focused Revision Q9 (R1): Poster Presented at PDA Week 2026.","authors":"Aron Yaeger","doi":"10.5731/pdajpst.2026.26429","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26429","url":null,"abstract":"A meaningful quality strategy is essential for a pharmaceutical or device company to achieve its strategic objectives. As companies evolve and move through the product development lifecycle, an early understanding of quality risks and gaps is essential to ensure success with regulatory approval, partner due-diligence, and agency audits. Using a unique approach which combines the concepts of Quality Risk Management (QRM) and Quality Management Maturity (QMM) with the FDA Six-Systems model, a strategic quality plan can be developed which identifies and prioritizes the improvement efforts needed to ensure a compliant and efficient approach to quality. This model can be applied to the US, EU and global expectations for compliance at every stage of the product lifecycle.This approach is unique in that it considers the organizational and strategic context of the quality unit when identifying risks and necessary mitigation actions. The result is a holistic action plan aligned with the company's strategic goals which addresses structural and behavioral deficiencies in addition to the technical compliance gaps normally identified during a typical gap assessment process.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 4","pages":"508-509"},"PeriodicalIF":0.0,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148689572","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

Usability of a High-Volume Autoinjector (HVAI): Addressing the User Need for Rapid High-Volume Subcutaneous Drug Delivery: Poster Presented at PDA Week 2026. 大容量自动注射器（HVAI）的可用性：满足用户对快速大容量皮下给药的需求：2026年PDA周上的海报。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-08-07 DOI: 10.5731/pdajpst.2026.26437

Scott Beacher, Baylor Frantz, Gina Bui, Kevin Swanson, Michael Travanty

{"title":"Usability of a High-Volume Autoinjector (HVAI): Addressing the User Need for Rapid High-Volume Subcutaneous Drug Delivery: Poster Presented at PDA Week 2026.","authors":"Scott Beacher, Baylor Frantz, Gina Bui, Kevin Swanson, Michael Travanty","doi":"10.5731/pdajpst.2026.26437","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26437","url":null,"abstract":"The increasing prevalence of biologic therapies requiring high injection volumes has created a need for devices that enable patient self-administration without compromising comfort or adherence. Conventional auto-injectors typically deliver 1-2 mL, necessitating multiple injections for higher doses, which can negatively impact patient experience and compliance. The high-volume auto-injector (HVAI) was developed to address this unmet need by enabling delivery of up to 10 mL in a single injection while maintaining ease of use and minimizing injection burden.A human factors study evaluated HVAI usability across representative user groups, including participants with physical impairments such as reduced hand strength or dexterity, which can make device use challenging. 74 injections were performed with injection times ranging from 21 to 60+ seconds; 69 were successful, five were incomplete. Of the successful injections, 88% met or exceeded a three-second post-injection hold time, the remaining injections with shorter hold times still delivered full doses. All five incomplete injections were classified as wet injections caused by premature device removal before the final indication. Despite the user dexterity impairments, most participants rated the auto-injector as easy to use and reported high confidence in dose delivery, supported by ergonomics and audible/tactile cues. Improvements in completion indicators were suggested.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 4","pages":"522-523"},"PeriodicalIF":0.0,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148689632","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

Cleaning Considerations for Antibody Drug Conjugate (ADC) Products: Poster Presented at PDA Week 2026. 抗体药物偶联（ADC）产品的清洁注意事项：在PDA周2026上发表的海报。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-08-07 DOI: 10.5731/pdajpst.2026.26409

Paul Lopolito, Brian Bosso, Dijana Hadziselimovic, John Schallom, Sarah Riley

引用次数: 0