PDA Journal of Pharmaceutical Science and Technology最新文献

{"title":"Vial Fogging in Lyophilized Biologics: From Haze to Clarity: Poster Presented at PDA Week 2026.","authors":"Jayasree Srinivasan","doi":"10.5731/pdajpst.2026.26439","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26439","url":null,"abstract":"<p><p>Vial fogging is a common but poorly understood phenomenon in lyophilized biologics. It presents as a hazy dried powder on the inner surface of the vial. While it is a cosmetic defect, severe fogging that reaches the vial neck or shoulder area could cause container closure integrity issues and rejection of batches. Besides, the phenomenon can be exacerbated at full-scale manufacturing. Fogging is influenced by several factors such as formulation characteristics, vial surface properties, dehydrogenation temperatures, and lyophilization process parameters. We investigated fogging using a placebo formulation and proprietary formulation and evaluated fill volumes, surfactants, specifically polysorbate 80, dehydrogenation temperatures, and different vial types. The case studies identified critical factors that affected the severity of fogging. We also present mitigation strategies to eliminate it.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 4","pages":"526-527"},"PeriodicalIF":0.0,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148689674","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":"Enhancing Sterile Vial Filling: Improved Filling Accuracy with Transition to 1.6 mm ID Teflon Tubing in Sterile/Parenteral Manufacturing: Poster Presented at PDA Week 2026.","authors":"Kristine Nguyen, Tony Knox","doi":"10.5731/pdajpst.2026.26414","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26414","url":null,"abstract":"<p><p>This project focuses on sterile processing improvements within parenteral manufacturing through the implementation of smaller diameter 1.6 mm ID Teflon tubing in a sterile filling line. The new tubing design addressed critical challenges related to yield optimization. Rigorous filling parameter cycle development testing and a novel 100% product weight verification process demonstrated the tubing's ability to maintain consistent fill weights even after experiencing off-gassing product during significant downtime events. This process enhancement led to significant improvements, including a complete reduction of out-of-tolerance fill weight alarms, a decrease in filling rejects per batch, and an increase in process capability (Cpk). This approach demonstrates how engineering innovations can enhance filling accuracy and operational efficiency in sterile manufacturing.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 4","pages":"488-489"},"PeriodicalIF":0.0,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148689462","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":"Using Moisture Sorption Isotherms to Determine the Total Water Content of a Lyophilized Product with Non-Destructive Water Activity Measurements: Poster Presented at PDA Week 2026.","authors":"Jillian Turner","doi":"10.5731/pdajpst.2026.26417","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26417","url":null,"abstract":"<p><p>Traditional moisture determination methods are time-consuming and destructive. By generating its moisture sorption isotherm, non-destructive headspace water activity measurements can be used to determine the total moisture content for a particular drug product. In this study, a Dynamic Vapor Sorption (DVS) Instrument was used to generate a moisture sorption isotherm by varying the relative humidity (%RH) over the sample for a pre-determined range. The sample sorbs water at each relative humidity step and the change in mass of the sample as the water is sorbed is measured. The sample mass at the end of each relative humidity step is used to generate the isotherm, which is unique to each drug product. To confirm the validity of the moisture sorption isotherm, headspace water activity and Karl Fischer measurements were taken on the same samples and plotted alongside the isotherm. The good correlation that was observed between the isotherm and the corresponding water activity and KF measurements demonstrated that non-destructive water activity measurements can successfully be used to accurately infer the total moisture content of a lyophilized product. Furthermore, the non-destructive nature of the headspace water activity analysis allows rapid acquisition of a statistically relevant number of samples for each production batch.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 4","pages":"492-493"},"PeriodicalIF":0.0,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148689624","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":"Using the Commercial Label to Map the Way for In-Use Study Design: Poster Presented at PDA Week 2026.","authors":"Jessica Fagan, Sarah Weiser","doi":"10.5731/pdajpst.2026.26438","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26438","url":null,"abstract":"<p><p>This poster explores how the intended commercial prescribing information should serve as a strategic anchor for designing drug product studies including those for in-use, short-term storage, and long-term stability protocols. By aligning study design with real-world use and regulatory expectations, teams can streamline development, purposefully guide CMC label content, and ensure the final drug product meets the storage and handling needs of the end users. Practical approaches, cross-functional collaboration, and examples of how early label intent can shape robust, patient-centric study strategies are highlighted.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 4","pages":"524-525"},"PeriodicalIF":0.0,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148689701","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":"Single-Use Systems Between Compliance and Circularity: A Critical View under EU-GMP-Annex 1 and European Green Deal.","authors":"Nicolas Huber","doi":"10.5731/pdajpst.2026-000025.1","DOIUrl":"10.5731/pdajpst.2026-000025.1","url":null,"abstract":"<p><p>The revision of EU-GMP-Annex 1 has accelerated the adoption of single-use systems (SUS) in aseptic pharmaceutical manufacturing by favoring closed, prequalified equipment that support contamination control while reducing cleaning effort, cross-contamination risk, and capital expenditure. The European Green Deal and circular economy initiatives increase pressure to reduce waste and improve end-of-life management of plastic-intensive technologies. Published life-cycle assessments indicate that SUS can lower water, energy, and cleaning chemical consumption compared with stainless-steel equipment but also contribute measurably to climate-change impact and resource depletion and generate complex plastic waste streams that are difficult to recycle at high quality. This commentary summarizes current evidence at the interface of sterility assurance, regulatory drivers, and environmental performance and argues that the use of SUS should move beyond a binary \"single-use versus stainless steel\" debate toward application-specific optimization and deliberate design for disassembly and material recovery.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":" ","pages":"401-404"},"PeriodicalIF":0.0,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148144264","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":"Investigation of Fill-Finish Tubing Compatibility in the Absence of Protein Stabilizers.","authors":"Stephanie K Vargas, Saeed Moshashaee, Teruna J Siahaan","doi":"10.5731/pdajpst.2025-000014.1","DOIUrl":"10.5731/pdajpst.2025-000014.1","url":null,"abstract":"<p><p>Optimization of the fill-finish process for a biotherapeutic is imperative for the highest quality drug product. Fill-finish is the last step in manufacturing and the last opportunity for intervention prior to entry into the supply chain. Typically, stabilizing excipients are utilized to mitigate the chemical or structural weaknesses of a protein therapeutic; however, there are cases in which the route of administration dictates the exclusion of key stabilizing excipients. When this is the case, process-related stabilization techniques need additional investigation. The goal of this work is to provide guidance and highlight key factors impacting enzyme stability in fill-finish processes in the absence of stabilizing excipients. Four tubing interfaces were studied in a recirculation model grouped as either silicone or thermoplastic elastomer. Colloidal stability was found to be the main route of degradation for this enzyme, producing soluble and insoluble aggregate, and various methods were employed to measure and characterize aggregation across a large dynamic size range. The flow imaging data captured high levels of particles that were shed from the thermoplastic elastomer tubing material in the 1-100 µm size range. Size-exclusion chromatography also indicated that the thermoplastic elastomer tubing produced unique multimeric soluble aggregates of the enzyme. Silicone tubing demonstrated superior performance compared to thermoplastic tubing in recirculation models. Silicone tubing produced a very low amount of subvisible particulate shedding with undetectable multimeric aggregate species as well as a better overall visual appearance after recirculation for up to 4 hours. The instability of the enzyme solution was not related to the shear stress in a flow field alone, but rather it was due to the use of an incompatible tubing material in the fill-finish process.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":" ","pages":"372-384"},"PeriodicalIF":0.0,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148144282","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":"In-Situ Verification of Disinfection Rotation for Contamination Control.","authors":"Laura Brennan, Terra Kremer, Gary Feehan, Yves Borjas, Oladayo Adekusibe","doi":"10.5731/pdajpst.2025-000057.1","DOIUrl":"10.5731/pdajpst.2025-000057.1","url":null,"abstract":"<p><strong>Aim: </strong>Pharmaceutical manufacturing companies have rotated different cleanroom disinfectants for many years. However, the reasons for this rotation have not always been clear, and if the question is posed to several different scientists, it is expected that varying reasons for rotating will be given. It is understood that regulators will also expect to see disinfectant rotation, but the written regulation giving guidance to this is considered quite vague. The updated European Union (EU) GMP Annex 1 \"Manufacture of Sterile Medicinal Products\" makes specific reference to rotating a sporicide as part of the regime. However, there is still no guidance available on how many or what chemistries to rotate, and the frequency of rotation to implement.</p><p><strong>Methods and results: </strong>This evaluation of in-situ environmental monitoring testing results, at four manufacturing sites addresses the question as to whether the rotation of more than one broad-spectrum disinfectant is more effective than the use of only one within a disinfection regime.</p><p><strong>Conclusion: </strong>In this study incorporating four manufacturing sites, the use of a single broad-spectrum disinfectant and a sporicide was demonstrated to be more effective than the rotation of two broad-spectrum disinfectants and a sporicide.</p><p><strong>Significance and impact: </strong>This evaluation provides data that demonstrates rotating two broad-spectrum disinfectants and a sporicide instead of one broad-spectrum disinfectant and a sporicide does not necessarily give any benefit in relation to environmental control. This has wider implications with regards to challenging the paradigm that rotating more than one broad-spectrum disinfectant in a cleanroom environment is preferable or beneficial.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":" ","pages":"385-394"},"PeriodicalIF":0.0,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148144296","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":"Toolbox for Bio Safety Manufacturing Waste Treatment.","authors":"Richard Denk, Reinhold Maeck, Dirk Motzkus, Carola Dreier, Bernhard Steidle, Harald Eriksson, Max Mittelviefhaus, Susanne Konrad, Charlotte Hieke, Andreas Seiffert, Maarten Prause, Nicolas Proeschel, Chris Williams, Stefan Woog, Joachim Regel, Sven Verguts, Sebastien Dalmagne","doi":"10.5731/pdajpst.2025-000066.1","DOIUrl":"10.5731/pdajpst.2025-000066.1","url":null,"abstract":"<p><p>This article provides comprehensive guidance on the safe handling, inactivation, and disposal of biohazardous waste generated in biomanufacturing processes. Effective waste treatment is a crucial element of biosafety management, as improper disposal of contaminated materials can pose serious risks to personnel, the environment, and surrounding communities. The document focuses on practical approaches and validation requirements for laboratories and production facilities working with Biosafety Level 1 and 2 (BSL-1/2) materials. The text highlights thermal inactivation as the most reliable and sustainable method for decontamination of both liquid and solid waste. Small liquid volumes can be sterilized using validated autoclave programs, whereas large volumes are treated in continuous-flow heat systems designed for energy efficiency and complete inactivation. Chemical inactivation serves as an alternative method, particularly for heat-resistant toxins such as saxitoxin or palytoxin. Solutions like sodium hypochlorite (NaOCl) or sodium hydroxide (NaOH) can effectively neutralize these substances, provided the reaction parameters are correctly set to the task and subsequent pH adjustments are validated to ensure environmental safety. Solid waste, including single-use components, filters, and contaminated materials, must be collected in leakproof containers, autoclaved, and disposed of as industrial waste. The document stresses the importance of autoclave validation, regular revalidation based on risk assessment, and technical safeguards such as exhaust air filtration or incineration to prevent the release of aerosols. Innovative solutions such as combined autoclave-shredder systems are introduced as highly efficient technologies that allow simultaneous shredding and sterilization, achieving up to 80% waste volume reduction and improving sterilization consistency. Overall, the article underscores a systematic, validated, and risk-based approach to biosafety waste treatment. It promotes the integration of technical precision, regulatory compliance, and sustainability to ensure that biohazardous materials are handled, inactivated, and disposed of safely within modern biomanufacturing environments.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":" ","pages":"395-400"},"PeriodicalIF":0.0,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148144246","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":"In Silico Strategies for Robust Process Development in Advanced Therapies: Poster Presented at PDA Week 2026.","authors":"Alyssa Burke","doi":"10.5731/pdajpst.2026.26421","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26421","url":null,"abstract":"<p><p>Robust process development enhances product quality while reducing time and cost across the product lifecycle. Systematic approaches are necessary to fully understand processes and control sources of variability; however, challenges increase when entering the field of autologous or personalized cell and gene therapies (ex. CAR-T) where each patient brings inherent biological variability. This presentation utilizes a simulated case study that combines Design of Experiments (DOE), mechanistic modeling, machine learning models, and Monte Carlo simulation to illustrate how complex processes can be analyzed in silico alongside benchtop experiments.A screening DOE study defined an efficient experimental space while mechanistic modeling generated critical quality attribute (CQA) outcomes to complement benchtop experimentation. These results trained regression and random forest models which were fed into Monte Carlo simulations. The simulations then quantify how patient-specific versus process-controlled variability contributes to overall outcome variance. Simulations can be repeated under different parameter constraints to ensure variability in patient-inputs can still lead to CQAs that are within acceptable limits.This integrated approach provides a more robust process development than DOE alone. This framework can aid in guiding process optimization and risk assessments both in early-stage process development and in continuous improvement during commercial production.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 4","pages":"498-499"},"PeriodicalIF":0.0,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148689528","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 Intensification, Powered by Collaboration: Poster Presented at PDA Week 2026.","authors":"Christopher J Hall, Mark Schofield, Kurt Boenning, Christina Caporale, Aydin Kavara, Kevin Hill-Byrne, Joanna Pezzini","doi":"10.5731/pdajpst.2026.26427","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26427","url":null,"abstract":"<p><p>As global demand for biologics and advanced therapeutics accelerates, the transition from batch to continuous biomanufacturing has gained popularity as a strategy to meet the needs for scalability, flexibility, and cost-efficiency. In this work, we showcase how strategic collaboration between Cytiva and PAK BioSolutions enables rapid deployment of continuous downstream processing using commercially available technologies.Central to this approach is the connection and organization of the PAK Pilot system. This powerful orchestration platform streamlines the integration and automation of unit operations, including the ÄKTA pcc™ continuous chromatography system, which utilizes MabSelect PrismA™ resin for capture and Capto™ adhere resins for polishing, alongside the implementation of continuous low pH virus inactivation and virus filtration.We show how this collaboration unlocks the potential of Cytiva process intensification tools across the manufacturing process and leverages the PAK Pilot system to significantly reduce the time it takes to develop and operate an interconnected process. We also show aspects of the seamless control and simplification of continuous processing workflows with PAK Pilot system. These combined Cytiva and PAK BioSolutions technologies demonstrate a practical and scalable path to connected, continuous biomanufacturing, transforming what was once complex and time-consuming into a manageable and efficient reality.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 4","pages":"506-507"},"PeriodicalIF":0.0,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148689531","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}