PDA Journal of Pharmaceutical Science and Technology最新文献_第3页

Combining a Respiration-Based Method with Universal qPCR for 3-Day Rapid Sterility Testing. 基于呼吸的方法与通用qPCR相结合用于3天快速无菌检测。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-08-14 DOI: 10.5731/pdajpst.2026-000020.1

Noah E Wallace, Afshan S Kidwai, Michael Knight, Aotian Yang, Friedrich von Wintzingerode

引用次数: 0

Data-Driven Contamination Control: Leveraging Inferential Statistics to Confirm State of Control Through Objective Performance Indicators. 数据驱动的污染控制：通过客观绩效指标利用推理统计来确认控制状态。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-08-07 DOI: 10.5731/pdajpst.2026-000009.1

Walid El Azab

{"title":"Data-Driven Contamination Control: Leveraging Inferential Statistics to Confirm State of Control Through Objective Performance Indicators.","authors":"Walid El Azab","doi":"10.5731/pdajpst.2026-000009.1","DOIUrl":"10.5731/pdajpst.2026-000009.1","url":null,"abstract":"Current contamination control strategy (CCS) performance reviews in pharmaceutical manufacturing often rely on descriptive statistical trending of key performance indicators (KPIs), focusing narrowly on compliance within defined periods rather than evaluating long-term process behavior and control. This approach limits the ability to detect systemic risks, verify the effectiveness of corrective and preventive actions (CAPAs), or assess performance across operational changes. To address these gaps, this article advocates for a shift from basic descriptive metrics to an inferential statistics and data science-driven framework. A structured four-step methodology is proposed: (1) anchoring KPIs to identified controls related to the risks, (2) classifying data to guide appropriate statistical test selection, (3) applying inferential statistics with predefined decision thresholds, and (4) integrating univariate analysis into multivariate monitoring where applicable. This approach enables objective confirmation of the state of control, evidence-based assessment of CAPA effectiveness, and data-driven resource prioritization where required. By adopting this rigorous, risk-based analytical foundation, sterility assurance and senior leadership can strengthen decision-making, enhance regulatory readiness, and progress from static monitoring toward predictive contamination control where applicable.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":" ","pages":"422-445"},"PeriodicalIF":0.0,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148144338","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

Stainless Steel Lifecycle Management: Poster Presented at PDA Week 2026. 不锈钢生命周期管理：海报在PDA周2026。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-08-07 DOI: 10.5731/pdajpst.2026.26432

Antonio Ortiz, Dijana Hadziselimovic, Daniel Klein, Paul Lopolito

{"title":"Stainless Steel Lifecycle Management: Poster Presented at PDA Week 2026.","authors":"Antonio Ortiz, Dijana Hadziselimovic, Daniel Klein, Paul Lopolito","doi":"10.5731/pdajpst.2026.26432","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26432","url":null,"abstract":"Due to its chromium-enriched passive surface, stainless steel is a material of choice for drug product manufacturing equipment as it offers excellent corrosion resistance under standard use conditions. However, exposure to aggressive processing conditions and chemistries commonly used in drug manufacturing can compromise the integrity of the passive layer. The deterioration of the passive layer can lead to localized corrosion, pitting, and the formation of rouge. The presence of these corrosion forms on stainless steel can alter product-contact surface conditions, reducing equipment lifespan and compromising the effectiveness of validated cleaning procedures.To support lifecycle management, a risk-based, preventive maintenance approach is recommended to sustain the validated state of equipment cleaning procedures and to extend the operational lifespan of stainless-steel manufacturing equipment. Regulatory guidelines reinforce the importance of maintaining process equipment to limit contamination or mechanical failure modes that can impact drug product quality. This presentation will address the material properties of stainless steel, analyze the mechanisms of rouge formation and corrosion, present remediation strategies, and propose a scientifically sound, risk-based preventive maintenance framework as part of a comprehensive lifecycle management approach to stainless steel process equipment.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 4","pages":"514-515"},"PeriodicalIF":0.0,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148689712","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

Analytical Method Transfer: Planning for Success: Poster Presented at PDA Week 2026. 分析方法转移：成功的规划：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.2026.26405

Brian Woodrow

{"title":"Analytical Method Transfer: Planning for Success: Poster Presented at PDA Week 2026.","authors":"Brian Woodrow","doi":"10.5731/pdajpst.2026.26405","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26405","url":null,"abstract":"Analytical method transfer is rarely an uneventful process regardless of the product's stage of development. Whether the product is in early phase clinicals or an approved commercial product the planning for an analytical method transfer is critical for achieving a successful outcome. To achieve successful transfer, it is imperative to understand and minimize any differences between the transferring lab and the receiving lab. This discussion will present a case study describing and demonstrating a process to gather, document and evaluate the necessary information to create a successful analytical method transfer for a product release/stability testing panel between two laboratories. For example, a protein content method, a potency/titer method and compendia methods will be discussed during this case study. The key to ensuring successful transfer is to produce, approve and train all parties on the plan in advance of any transfer activity. This process provides a clear understanding of the scope of the transfer plan, any issues and resolutions of issues which occurred during the execution of the plan, and the resulting data to support the transfer between laboratories. This process can be applied to a single analytical method or an entire product testing panel at any stage of development.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 4","pages":"472-473"},"PeriodicalIF":0.0,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148689636","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

Advancing Subcutaneous Delivery: Evaluation of Near-Body Auto-Injector Systems for High-Volume Biologic Administration with Human Hyaluronidase: Poster Presented at PDA Week 2026. 推进皮下给药：评估人体透明质酸酶大剂量生物给药的近体自动注射系统：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.2026.26404

Kallie Johnson, Ryan Wangsnes, Baylor Frantz, Robert J Connor, Tara Nekoroski, Kevin D Swanson, David W Kang

{"title":"Advancing Subcutaneous Delivery: Evaluation of Near-Body Auto-Injector Systems for High-Volume Biologic Administration with Human Hyaluronidase: Poster Presented at PDA Week 2026.","authors":"Kallie Johnson, Ryan Wangsnes, Baylor Frantz, Robert J Connor, Tara Nekoroski, Kevin D Swanson, David W Kang","doi":"10.5731/pdajpst.2026.26404","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26404","url":null,"abstract":"Subcutaneous (SC) delivery of biologics is evolving to accommodate the greater volumes and doses required for efficacy. Conventional handheld auto-injectors are constrained by volume and speed limitations, prompting the development of high-volume auto-injectors (HVAIs) and wearable on-body injectors (OBI). A Near-Body Injector (NBI) system offers a novel approach by combining the benefits of high-volume delivery with hands-free operation, without the need for adhesive attachment associated with OBI's by using a standard winged infusion set and a mechanical priming mechanism incorporated into the device. This study evaluated the feasibility of a NBI system in a porcine model, delivering SC immunoglobulin alone and in combination with recombinant human hyaluronidase PH20 (rHuPH20), an enzyme known to enhance SC dispersion and absorption.Results demonstrated that the NBI system was easily primed and effectively delivered 10 mL SC. Co-formulation with rHuPH20 significantly improved injection performance, reducing delivery time by ∼13%, eliminating back-leakage, and decreasing swelling volume and induration at the injection site. These findings support the clinical potential of NBI systems for hands-free high-volume, high-dose biologic administration, offering an alternative to conventional SC delivery methods.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 4","pages":"470-471"},"PeriodicalIF":0.0,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148689709","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

Quality in Small Pharma: Stability Testing and Quality Management Systems: Poster Presented at PDA Week 2026. 小型制药的质量：稳定性测试和质量管理系统：2026年PDA周上的海报。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-08-07 DOI: 10.5731/pdajpst.2026.26434

Aidan Strealy

引用次数: 0

Modernizing Growth Promotion Testing using APAS^® Independence: Poster Presented at PDA Week 2026. 使用APAS®独立性实现增长促进测试的现代化：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.2026.26425

Chris Ramsey, Albert Phan, Steven Giglio

{"title":"Modernizing Growth Promotion Testing using APAS® Independence: Poster Presented at PDA Week 2026.","authors":"Chris Ramsey, Albert Phan, Steven Giglio","doi":"10.5731/pdajpst.2026.26425","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26425","url":null,"abstract":"Agar-based methods remain a cornerstone of environmental monitoring in cleanroom environments due to their unmatched ability to detect viable microorganisms. The Growth Promotion Test (GPT) remains a regulatory requirement to verify the performance of each new batch of culture media. While the use of freeze-dried organism pellets has improved inoculation accuracy, colony enumeration is still largely performed manually, introducing variability and potential for human error. This presentation explores how the APAS Independence system leverages artificial intelligence (AI) and advanced imaging techniques to streamline GPT workflows. By mitigating common sources of counting inaccuracy such as lighting, plate markings, and user fatigue, APAS technology delivers consistent, auditable results that integrate directly with laboratory information management systems (LIMS) for compliance with 21 CFR Part 11. Beyond improving accuracy and efficiency, the system enhances traceability and supports long-term performance trending, making it a valuable tool for modernizing GPT without disrupting existing procedures.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 4","pages":"502-503"},"PeriodicalIF":0.0,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148689565","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

Global Aseptic Processing Compliance Trends: Enforcement Data Insights Across FDA, EMA, and PIC/S Agencies: Poster Presented at PDA Week 2026. 全球无菌处理合规趋势：FDA、EMA和PIC/S机构的执法数据洞察：2026年PDA周上发布的海报

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-08-07 DOI: 10.5731/pdajpst.2026.26418

Julia Gallwitz

{"title":"Global Aseptic Processing Compliance Trends: Enforcement Data Insights Across FDA, EMA, and PIC/S Agencies: Poster Presented at PDA Week 2026.","authors":"Julia Gallwitz","doi":"10.5731/pdajpst.2026.26418","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26418","url":null,"abstract":"Aseptic processing remains one of the most challenging and closely scrutinized areas in pharmaceutical manufacturing. Using Redica Systems' global inspection and enforcement database spanning FDA, EMA/MHRA, and other PIC/S member agencies, this presentation analyzes compliance findings from 2022 to the present to highlight both persistent challenges and emerging risks in sterile manufacturing.Key themes include environmental monitoring and contamination control strategies, aseptic technique and human factors, sterilization validation, gowning and operator qualification, airflow visualization and smoke studies, and cleaning and disinfection effectiveness. We will also examine how regulatory expectations have shifted following the implementation of the revised EU GMP Annex 1, with particular attention to contamination control strategy and the adoption of barrier technologies.To illustrate these broader global trends, FDA enforcement serves as a case study. Sterility-related issues account for over 40% of production observations in 483s and over half of production deficiencies in Warning Letters. Inspections citing sterility issues were far more likely to escalate. Viewed alongside inspection findings from EMA and PIC/S agencies, these insights will give attendees a clear view of the compliance landscape and how global regulators are converging-or diverging-on expectations for sterile manufacturing.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 4","pages":"494-495"},"PeriodicalIF":0.0,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148689594","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

Risk-Based Extraction and Leaching Studies for Injectable Drug Products: Addressing Process Impurities, Nitrosamine Formation, and Syringe Siliconization Effects: Poster Presented at PDA Week 2026. 基于风险的可注射药物提取和浸出研究：处理工艺杂质，亚硝胺形成和注射器硅化效应：2026年PDA周的海报。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-08-07 DOI: 10.5731/pdajpst.2026.26431

Piyush Ranjan

{"title":"Risk-Based Extraction and Leaching Studies for Injectable Drug Products: Addressing Process Impurities, Nitrosamine Formation, and Syringe Siliconization Effects: Poster Presented at PDA Week 2026.","authors":"Piyush Ranjan","doi":"10.5731/pdajpst.2026.26431","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26431","url":null,"abstract":"The safety and quality of injectable drug products are influenced not only by formulation and manufacturing processes but also by the container closure system, including prefilled syringes and vials. Extractables and leachables (E&L) from elastomers, plastics, adhesives, and coatings can migrate into formulations, affecting safety, efficacy, and compliance. In parallel, residual process impurities may compromise stability during long-term storage. Emerging concerns highlight additional risks. Formation of nitrosamine compounds arising from drug-excipient or impurity interactions has raised global regulatory scrutiny due to their potential carcinogenicity. Likewise, siliconization of prefilled syringes while essential for functionality can alter glide forces and introduce silicone oil droplets, with implications for both product performance and patient safety. These evolving challenges underscore the importance of a holistic risk-based E&L framework.This presentation will discuss strategies aligned with USP < 1663>, < 1664>, ICH, and EMA guidance with emphasis on: Characterizing and monitoring E&L under stability conditionsEvaluating nitrosamine formation and syringe siliconization risksApplying robust analytical and mechanical testing methodologiesIntegrating findings into lifecycle and regulatory strategiesHolistic E&L evaluations incorporating chemical, mechanical, and toxicological perspectives strengthen product quality, patient safety, and regulatory confidence while supporting innovation in injectable drug delivery systems.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 4","pages":"512-513"},"PeriodicalIF":0.0,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148689676","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 Breakdown of the FDA Announcement of Unannounced Foreign-Based Inspections from the Quantitative Perspective: Poster Presented at PDA Week 2026. 从定量的角度分析FDA关于未通知的国外检查的公告：在PDA Week 2026上展示的海报。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-08-07 DOI: 10.5731/pdajpst.2026.26401

Zephaniah Odidika

引用次数: 0