PDA Journal of Pharmaceutical Science and Technology最新文献

{"title":"Addressing the Workforce Shortage: A Collaborative Approach to GMP Programs for Building a Skilled Pharma and Biotech Talent Pipeline: Poster Presented at PDA Week 2025.","authors":"Christian Spiak","doi":"10.5731/pdajpst.2025.25422","DOIUrl":"https://doi.org/10.5731/pdajpst.2025.25422","url":null,"abstract":"<p><p>The shortage of skilled workers in the pharmaceutical and biotech sectors has become a significant barrier to industry growth and the success of new companies in local areas. Without a reliable talent pool trained in essential industry standards, companies struggle to meet regulatory requirements, operate efficiently, and scale their operations. This challenge highlights the pressing need for a collaborative approach between educational institutions, economic development organizations, and industry leaders to develop a steady supply of skilled professionals. A key solution to this issue has been the implementation of GMP (Good Manufacturing Practices) Bootcamp programs, where industry leaders and colleges partner to offer hands-on training in foundational GMP concepts. These programs are designed to benefit new graduates, career changers, and others seeking stable, well-paying jobs by equipping them with skills that are immediately relevant to the pharmaceutical and biotech sectors. For companies, hiring workers already trained in GMP standards shortens onboarding times and reduces training costs, while local economic development groups benefit from a talent pipeline that attracts industry investment and fosters job growth. This collaboration not only addresses the skilled labor gap but also supports regional economic development by creating attractive, sustainable career opportunities in these growing sectors.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"79 4","pages":"466-467"},"PeriodicalIF":0.0,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144765168","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}

{"title":"The Next Step in the Journey to a Full Electronic Quality Management System (EQMS) in the Irish Blood Transfusion Service: Poster Presented at PDA Week 2025.","authors":"Rebecca Walden","doi":"10.5731/pdajpst.2025.25427","DOIUrl":"https://doi.org/10.5731/pdajpst.2025.25427","url":null,"abstract":"<p><p>In 2024 we completed a case study outlining the development of a bespoke User Requirement Specification (URS) for a full Electronic Quality Management System (EQMS) in the Irish Blood Transfusion Service (IBTS) as part of our 2021-2025 Strategy. This abstract outlines the next stage in the project where we evaluated a number of tender responses to the URS and chose a vendor based on a number of criteria using a coring methodology. We also discuss the planning of the next project stages to prepare for pre installation testing, phase planning and outlining validation requirements. Methods 1. How to review the tender response? We created scoring for Functional, Non Functional and Costings responses 2. How did we evaluate the responses and score the responses? 3. Completed summary comments and final ranking which were reviewed and discussed by the project steering committee Results 1. Award contract and develop SLA 2. Project planning for the next stages 3. Preparation of data for moving databases.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"79 4","pages":"476-477"},"PeriodicalIF":0.0,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144765193","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}

{"title":"A Biosafety Toolbox for Manufacturing with Single-Use Systems.","authors":"Richard Denk, Reinhold Maeck, Dirk Motzkus, Carola Dreier, Bernhard Steidle, Andreas Seiffert, Stefan Woog, Harald Eriksson, Charlotte Hieke, Chris Williams, Susanne Konrad, Joachim Regel, Sven Verguts","doi":"10.5731/pdajpst.2025-000003.1","DOIUrl":"10.5731/pdajpst.2025-000003.1","url":null,"abstract":"<p><p>As markets for recombinant biologicals constantly grow, the risks related to the biohazardous materials used are not yet always understood and assessed systematically. Thus, there is a strong need to systematically assess technical solutions in the good manufacturing practice (GMP) area and best practices for all steps in biotechnological production using biohazardous materials up to biological safety level 2 (BSL2). Especially viral vectors, as virus-based vaccines are coming to market as novel therapies, asking for different safety requirements. As single-use solutions (SUSs) are widely used in clinical and production scale in upstream and downstream processing until final fill operations, new practices must be developed with a different approach to enable production under BSL2. Production of biologics that are produced in the BSL2 area regime using SUSs must be reviewed under different aspects in terms of safety for the product and staff equally and probable contamination of the environment. SUSs for this new purpose must be differently handled with care from goods entry until final discard of products post usage. The production starting at fabrication of the SUS items itself might require modifications. The design of SUS items for the BSL2 purpose must be tested already in a different way in production to fulfill the higher safety level regimes to protect the product and operators. In this paper, we give examples for consideration of how to unpack and store such SUS consumables and which conditions in the facility are favorable in combination with proper staff training. Examples of suitable components and existing SUS equipments for the upstream and downstream processing of such products, to give operators, suite and plant managers, A + E with planners, and people in regulatory departments the needed information to enable the safe and regulatory aligned production of such biologic therapies.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":" ","pages":"357-369"},"PeriodicalIF":0.0,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144132798","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}

{"title":"Kite Pharma R&D Quality Internship: Poster Presented at PDA Week 2025.","authors":"Devon B Cooper, Caitlin Fisher, Marjorie Stevenson","doi":"10.5731/pdajpst.2025.25404","DOIUrl":"https://doi.org/10.5731/pdajpst.2025.25404","url":null,"abstract":"<p><p>The R&D Quality (RDQ) Internship at Kite Pharma provided me with a comprehensive introduction to ensuring compliance with health authority regulations and fostering a quality-driven culture within clinical research and development. Key contributions included preparing for regulatory inspections by reconciling clinical trial timelines, conducting gap analyses, and developing mock inspection documentation. I also supported Standard Operating Procedure (SOP) updates to enhance consistency and developed engaging training materials, such as the Quality GCP Training Game, to strengthen employee understanding of Good Clinical Practices (GCP) across departments and functional areas. Additionally, I conducted a training gap analysis to assess current GCP audit report writing skills and support the future creation of team training materials. Overall, this internship reinforced the importance of quality in protecting patients, ensuring product reliability, and managing risks in the development of innovative therapies, and further fueled my interest in the field of Quality.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"79 4","pages":"430-431"},"PeriodicalIF":0.0,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144765183","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}

{"title":"Maximizing Gene Therapy Doses for Patients: Poster Presented at PDA Week 2025.","authors":"Peter Gegusch","doi":"10.5731/pdajpst.2025.25409","DOIUrl":"https://doi.org/10.5731/pdajpst.2025.25409","url":null,"abstract":"<p><p>Proposal DescriptionGene therapies hold tremendous potential, yet manual operations, product loss, and high costs impede patient access to vital treatments. The fill/finish processes are pivotal in optimizing drug product availability. Precision is paramount in formulating, filling, and packaging the therapies to preserve their efficacy and integrity. These challenges are leveraging advanced technologies like the adaptable Optima FillCell. This flexible and modular system streamlines operations, reducing reliance on manual labor and mitigating the risk of errors and contamination. Real-time monitoring and data analysis provide crucial insights, empowering manufacturers to optimize production parameters and minimize wastage, ultimately increasing the number of viable drug vials. By enhancing efficiency and maximizing overall yield.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"79 4","pages":"440-441"},"PeriodicalIF":0.0,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144765186","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}

{"title":"Next GEN Pharma Machinery - Flexible Fill and Finish: Poster Presented at PDA Week 2025.","authors":"Juergen Metzger","doi":"10.5731/pdajpst.2025.25414","DOIUrl":"https://doi.org/10.5731/pdajpst.2025.25414","url":null,"abstract":"<p><p>The pharmaceutical industry is constantly evolving, driven by technological innovations aimed at enhancing efficiency, quality, and adaptability in drug manufacturing processes. This presentation highlights the success story of flexible fill and finish platforms over the past decade and introduces groundbreaking advancements shaping the next generation of pharmaceutical manufacturing, such as new container transfer solutions and the next generation of isolated pharma machinery. It also includes regulatory aspects like EU GMP Annex 1 and addresses the requirements relating to novel medicinal products and their individual properties. By exploring these technological advancements, the presentation aims to provide insight into the transformative potential of these innovations in optimizing drug manufacturing processes, ensuring product quality, and meeting the evolving demands of the healthcare landscape.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"79 4","pages":"450-451"},"PeriodicalIF":0.0,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144765189","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}

{"title":"A Quality by Design (QbD) Approach to Microbial Retention Validation: Poster Presented at PDA Week 2025.","authors":"Annie Leahy, Jennifer Juneau, Corinne Miller, Nhung Nguyen, Parag Kolhe","doi":"10.5731/pdajpst.2025.25411","DOIUrl":"https://doi.org/10.5731/pdajpst.2025.25411","url":null,"abstract":"<p><p>Regulatory and manufacturing requirements exist to perform product-specific microbial retention testing on sterilizing filters. The implementation of a Quality by Design approach to microbial retention testing supports a paradigm that would obviate the need for product-specific testing for early-stage products that do not have the quantity of material required to easily and efficiently perform such testing. Process and product parameters were varied to determine their effect on microbial retention.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"79 4","pages":"444-445"},"PeriodicalIF":0.0,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144765167","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}

{"title":"Beyond Quality Culture: Fostering a Holistic Work Environment: Poster Presented at PDA Week 2025.","authors":"Kumbirai Dhliwayo","doi":"10.5731/pdajpst.2025.25408","DOIUrl":"https://doi.org/10.5731/pdajpst.2025.25408","url":null,"abstract":"<p><p>Quality culture is an integral part of a workplace and is one of the foundational traits that lead teams to prioritize compliance and the safety of patients. However, quality culture is merely one of the byproducts of corporate culture. Looking beyond quality culture means examining and implementing the various elements that contribute to a great corporate culture, such as a company's vision, core values, management practices, accountability, and effective communication. Understanding these elements and how they are interconnected within each company can lead to a culture that not only delivers high-quality products or services but also fosters employee satisfaction, engagement, and overall organizational success. As an industry, we need to rethink how we view quality culture.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"79 4","pages":"438-439"},"PeriodicalIF":0.0,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144765171","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}

{"title":"Process Validation for Lyophilized Drug Products: Comparing a Program for Continued Process Verification in Different Lyophilized Products: Poster Presented at PDA Week 2025.","authors":"Abirami Natesh, Denise Miller","doi":"10.5731/pdajpst.2025.25402","DOIUrl":"https://doi.org/10.5731/pdajpst.2025.25402","url":null,"abstract":"<p><p>The 2011 FDA Guidance for Industry, \"Process Validation: General Principles and Practices,\" emphasizes maintaining control of manufacturing processes throughout the product lifecycle through constant reevaluation. For lyophilized drug products, Critical Quality Attributes (CQAs) identified in Stage 1 can be effectively trended and reported annually. However, monitoring Critical Process Parameters (CPPs) such as shelf temperature, chamber pressure, and time presents greater challenges. Methods like comparing actual variation to averages, targets, or proven acceptable ranges (PARs) are defined in Stage 1, validated in Stage 2, and continually assured in Stage 3. Demonstrating a state of control for lyophilization parameters is vital, yet complex. Previously, classical statistical methods were used to evaluate process variability by analyzing data from multiple batches of the same product. These techniques revealed actionable insights into maintaining consistent control. However, in a multiple product facility, utilizing multiple methods to analyze various products can be inexpedient. Expanding on previous research, various batches of lyophilized products were assessed to verify the relative robustness of a specific statistical methodology for the sake of efficiency. This analysis underscores the importance of continual monitoring in lyophilization to ensure product quality and regulatory compliance.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"79 4","pages":"426-427"},"PeriodicalIF":0.0,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144765190","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}

{"title":"Equipment and Process Validation for an Industrial VH2O2 Sterilization Application: Poster Presented at PDA Week 2025.","authors":"Mary Van Gaasbeck Carico","doi":"10.5731/pdajpst.2025.25426","DOIUrl":"https://doi.org/10.5731/pdajpst.2025.25426","url":null,"abstract":"<p><p>Sterilization of sensitive drug delivery devices such as pre-filled syringes can be significantly enable by implementing Vaporized Hydrogen Peroxide VH2O2 (VHP) Low Temperature Sterilization for the process application. Utilizing VH2O2 has been widely used in biodecontamination of e.g., Pharmaceutical manufacturing spaces, isolators and lyophilizers for over 30 years, and terminal sterilization of sensitive combination products and other medical devices by VH2O2 also increasingly for the past 20 years. The 2022 published ISO 22441 for process validation, adoption by FDA and several other countries and FDA moving VH2O2 sterilization to Established Category A are strengthening its position. The near future EN 17180 for VH2O2 sterilizer equipment will provide specific guidance for implementing to pharmaceutical manufacturing process. Further, the work on VH2O2 specific biological indicator standard ISO 11138-6 and upcoming revision of the AAMI TIR 17 for guidance on material compatibility for sterilization modalities, will provide additional help and guidance. This presentation will provide guidance on all key elements of equipment and process validation of VH2O2 sterilizers and developed processes and recommendation on steps of application implementation, and also puts focus on key requirements of conformance and related materials and documentation, in the light of typical product applications sterilized by VH2O2.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"79 4","pages":"474-475"},"PeriodicalIF":0.0,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144765176","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}