PDA Journal of Pharmaceutical Science and Technology最新文献

A Holistic Approach for Filling Volume Variability Evaluation and Control with Statistical Tool. 利用统计工具评估和控制填充量变异性的整体方法。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2025-05-14 DOI: 10.5731/pdajpst.2023.012867

Mingyang Hei, Qingqing She, Quanmin Chen, Zhaowei Jin, Chunmeng Sun, Jiasheng Tu, Jeremy Guo

{"title":"A Holistic Approach for Filling Volume Variability Evaluation and Control with Statistical Tool.","authors":"Mingyang Hei, Qingqing She, Quanmin Chen, Zhaowei Jin, Chunmeng Sun, Jiasheng Tu, Jeremy Guo","doi":"10.5731/pdajpst.2023.012867","DOIUrl":"10.5731/pdajpst.2023.012867","url":null,"abstract":"Vial and syringe filling by peristaltic pump has been widely implemented by contract manufacturing organizations and biopharmaceutical companies. Filling volume is commonly considered a critical quality attribute related to the aseptic filling process, and the variation needs to be well controlled to guarantee the safety, efficacy, and consistency of drug products. However, the criteria for justifying the filling variation and underlying mechanisms that affect the variability are not fully revealed quantitatively in the literatures. This study selected filling accuracy, filling process capability, and filling precision as three criteria for evaluating the filling process performance with four statistical indexes: Relative Error Mean, Critical Control Limit (Cpk ≥ 1.33), Relative Standard Deviation, and Relative Moving Range Mean. The impact of liquid properties, pump tubing sizes, and pump settings on these indexes was investigated using a bench-top system with a peristatic pump and a high-precision balance. The results showed that the viscosity, target filling volume, pump tubing size, pump speed, acceleration/deceleration rate, and suck-back had a statistically significant influence on the filling volume variability. Definitive Screening Design was further applied to clarify and visualize the priorities and interaction impact of these factors on filling volume variability. A stepwise approach for filling volume variability optimization and control based on predictive models was established and verified for drug product solution with viscosity between 1-23 cp and target filling volume between 0.2-2.0 mL.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":" ","pages":"157-169"},"PeriodicalIF":0.0,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141470062","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

Application of Modeling as a Tool for Early Derisking of Parenteral Delivery, from the Primary Container to the Tissue. 从主要容器到组织，建模作为早期降低肠外分娩风险的工具的应用。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2025-05-14 DOI: 10.5731/pdajpst.2025.25206

Ludovic Gil, Christopher Basciano, Sean McGrath, Julien Singer

{"title":"Application of Modeling as a Tool for Early Derisking of Parenteral Delivery, from the Primary Container to the Tissue.","authors":"Ludovic Gil, Christopher Basciano, Sean McGrath, Julien Singer","doi":"10.5731/pdajpst.2025.25206","DOIUrl":"https://doi.org/10.5731/pdajpst.2025.25206","url":null,"abstract":"In silico modeling of subcutaneous injections is a promising tool to derisk and optimize the development of injections systems and improve preliminary understanding of the injectability of drugs. Such modeling can be leveraged early in development, prior to pre-clinical studies, to reduce testing burden and effectively predict aspects such as the time and forces required for full dose delivery into tissue and the tissue-injectate-device interactions. In this work, we address the three main in silico pillars (primary container, injection device, and tissue) that are necessary to simulate a parenteral injection. We showcase how their modeling can be combined and applied to various delivery systems and injection conditions to enable appropriate systems and parameters selection to achieve desired performance. Case studies of viscous drugs in PFS/AI and wearable injection systems with non-rigid component properties are presented to highlight the theoretical treatment of interfaces, the critical inputs required to achieve accurate predictions, the insights gained, and the good agreement between model predictions and experimental results.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"79 2","pages":"246-247"},"PeriodicalIF":0.0,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144079443","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

Evaluation of Extreme Depyrogenation Conditions on the Surface Hydrolytic Resistance of Glass Containers for Pharmaceutical Use. 评估极端去热氮条件对药用玻璃容器表面抗水解性的影响。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2025-05-14 DOI: 10.5731/pdajpst.2024.012972

Massimo Guglielmi, Satoshi Arai, Peggy Georges, Amy Meysner, Peter Otton, Serena Panighello, Volker Rupertus, Jingwei Zhang, Daniele Zuccato

{"title":"Evaluation of Extreme Depyrogenation Conditions on the Surface Hydrolytic Resistance of Glass Containers for Pharmaceutical Use.","authors":"Massimo Guglielmi, Satoshi Arai, Peggy Georges, Amy Meysner, Peter Otton, Serena Panighello, Volker Rupertus, Jingwei Zhang, Daniele Zuccato","doi":"10.5731/pdajpst.2024.012972","DOIUrl":"10.5731/pdajpst.2024.012972","url":null,"abstract":"This paper is the result of a round-robin activity run by the Technical Committee TC12, Pharma Packaging, of the International Commission on Glass (ICG). The study was motivated by a concern about the risk that the depyrogenation treatment of glass vials, when performed in an abnormal way that deviates from the usual procedure, may have a negative impact on the hydrolytic resistance of the container inner surface after filling with the drug product, for example, by increasing the release of leacheables and/or the propensity to delamination. The study was executed by using 10 mL clear type I borosilicate glass vials representing four different compositions. For the applied depyrogenation process, extreme parameters were chosen with maximum temperature up to 400°C, exposure times up to 72 hours, and different amounts of residual water inside as starting conditions. Those treated samples were tested in seven different laboratories as a round-robin test. A large amount of data was obtained, which clearly indicate that the hydrolytic resistance performance of the Type I borosilicate glass vials is not affected even by such extreme depyrogenation conditions (e.g., 400°C, 72 hours, and not perfectly dried inside). This is an important and useful result, both for glass and pharma companies, based on the 12,000 analytical data collected during the interlaboratory activity.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":" ","pages":"170-177"},"PeriodicalIF":0.0,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142695342","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

Sustainable Design for Healthcare Devices: Pathways Toward Net Zero. 医疗设备的可持续设计：通往净零的道路。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2025-05-14 DOI: 10.5731/pdajpst.2025.25204

William J Davies

{"title":"Sustainable Design for Healthcare Devices: Pathways Toward Net Zero.","authors":"William J Davies","doi":"10.5731/pdajpst.2025.25204","DOIUrl":"https://doi.org/10.5731/pdajpst.2025.25204","url":null,"abstract":"We're starting to see a huge shift in the healthcare industry towards sustainability, with stakeholders throughout the sector aiming to drive down emissions and reduce environmental impacts. This graphic focuses on device design, and applies to any sector of the industry. It looks at every phase of a product's lifecycle, and breaks these down into focal points and design opportunities for footprint reduction.The ultimate goal in sustainability is The Circular Economy, the definition of which is the reduction, capture, and reuse of all embodied resources into an indefinite loop, with minimal negative external effects. The graphic illustrates how the journey to circularity can be achieved through considered design at every one of those lifecycle phases. It examines opportunities within raw materials, manufacturing, transport, use, and end-of-life, considering not just technical approaches but business model development and user behaviours as well, aiming to cohesively target a cradle-to-cradle system. Even for products and services where full circularity is not realistic, it identifies multiple opportunities for good design to reduce emissions and perhaps ease the journey to circularity in the future.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"79 2","pages":"242-243"},"PeriodicalIF":0.0,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144079542","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 Assurance. 质量保证。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2025-05-14 DOI: 10.5731/pdajpst.2025.001942

引用次数: 0

Challenges and Solutions to Manufacturing of Low-Viscosity, Ultra-High Concentration IgG1 Drug Products: From Late Downstream Process to Final Fill Finish Processing. 生产低粘度、超高浓度 IgG1 药物产品所面临的挑战和解决方案：从后期下游工艺到最终灌装加工。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2025-05-14 DOI: 10.5731/pdajpst.2023.012873

Vaibhav Deokar, Alok Sharma, Subrahmanyam M Volety

{"title":"Challenges and Solutions to Manufacturing of Low-Viscosity, Ultra-High Concentration IgG1 Drug Products: From Late Downstream Process to Final Fill Finish Processing.","authors":"Vaibhav Deokar, Alok Sharma, Subrahmanyam M Volety","doi":"10.5731/pdajpst.2023.012873","DOIUrl":"10.5731/pdajpst.2023.012873","url":null,"abstract":"Challenges in the manufacturing of high-concentration antibody formulations have seldom been discussed. These are observed mainly from late downstream operations where the antibody gets concentrated to its final strength to final fill finish processing and containerization of the product. The present paper summarizes the challenges typically observed in manufacturing and processing of high-concentration antibody products and provides turnkey solutions to these typical challenges in order to have a consistent and robust manufacturing process for these products. Immunoglobulin G1 (IgG1) has been used as a model protein for studying the challenges and providing solutions to them. The late downstream challenges, like increased viscosity limiting further concentration, can be resolved by use of viscosity modifying agents in the formulation. Replacement of the conventionally used 'A' screen membranes with 'D' screen or using single pass tangential flow filtration can further provide an in targeting higher concentrations for the same protein with lesser shear and aggregation. Using a 0.5 µm/0.2 µm asymmetric or bilayered membrane instead of the conventional 0.2 µm membrane resulted in better flux during filtration of a high-concentration IgG1 formulation. In-process holding time during the filling operation was optimized to be <60 min based on the nozzle drying time for the high-concentration IgG1 formulation. An appropriate control strategy of replacing filling nozzles and performing periodic fill weight checks was proposed for the fill-finish process of a high-concentration IgG1 formulation.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":" ","pages":"218-235"},"PeriodicalIF":0.0,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141470063","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

Bridging the Gap-Ensuring Digital End-to-End PFS Integrity via an RFID-Based Seal: Holistic Digitalization of Inventory Management and Diversion Prevention of Hospital Drugs. 弥合差距-通过基于rfid的印章确保数字端到端PFS完整性：库存管理和医院药品分流预防的整体数字化。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2025-05-14 DOI: 10.5731/pdajpst.2025.25207

Sebastian Muenscher

引用次数: 0

A User-Preference Study on an Ophthalmic Injection Device to Facilitate Microliter Dosing for Intravitreal Injections. 一种便于玻璃体内注射微升剂量的眼科注射装置的用户偏好研究。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2025-05-14 DOI: 10.5731/pdajpst.2025.25201

Reza Abedian, Juergen Pfrang, Simon Buerdel, Nicole Forster, Sabine Websky

{"title":"A User-Preference Study on an Ophthalmic Injection Device to Facilitate Microliter Dosing for Intravitreal Injections.","authors":"Reza Abedian, Juergen Pfrang, Simon Buerdel, Nicole Forster, Sabine Websky","doi":"10.5731/pdajpst.2025.25201","DOIUrl":"https://doi.org/10.5731/pdajpst.2025.25201","url":null,"abstract":"This work focused on understanding the current practice of the intravitreal injections (IVIs) and existing challenges for both patients and healthcare professionals with the ultimate goal of developing a combination device concept for intravitreal injections. Using a systematic approach, an initial user preference study was initiated that incorporated an online survey designed and conducted with retinologists from the EU countries (n = 25), followed by in-person interviews with national and international KOLs (n = 5). Multiple feasibility studies were conducted with focus on the unmet needs of key users such as handling characteristics and accuracy of the injection volume focusing on potential device solutions to address these unmet needs. Finally, laboratory testing and user experience evaluation of device potential concepts were used to find the best fitting device concept for injections of a fixed dose (0.05 ml) into the eye. Both qualitative evaluation and statistical analysis were used to study significant differences between the results of injection with device and standard of care. Compared to the manual IVI procedure, an automated device has the potential to increase safety for patients, decrease procedure times, allow for integrated data storage and documentation, and reduce costs for medical staff and expensive operating rooms.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"79 2","pages":"236-237"},"PeriodicalIF":0.0,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144079527","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

Multiphysics Simulation of Needle Clogging in Pre-Filled Syringes. 预充注射器中针头堵塞的多物理场模拟。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2025-05-14 DOI: 10.5731/pdajpst.2025.25202

Joseph M Barakat, Matthew Hancock

{"title":"Multiphysics Simulation of Needle Clogging in Pre-Filled Syringes.","authors":"Joseph M Barakat, Matthew Hancock","doi":"10.5731/pdajpst.2025.25202","DOIUrl":"https://doi.org/10.5731/pdajpst.2025.25202","url":null,"abstract":"Needle clogging in prefilled syringes can impede drug product injection and negatively impact drug product quality. Computer simulations provide a useful tool to understand clogging mechanisms and elucidate design strategies to minimize or avoid clogging. In this talk, we present multiphysics simulations of clogging in needle syringes prefilled with a monoclonal antibody solution. We use these simulations to evaluate several putative clogging mechanisms, including: (1) fluid ingress into the needle and subsequent solvent evaporation leading to a dried solid plug, and (2) shear-induced jamming driven by rapid plunger compression. We study the impact of solution properties, needle diameter, barrel hub shape, and plunger speed on the onset of clogging. The effect of protein concentration on the solution viscosity is considered. Simulations such as these can offer insight into the critical material, geometric, and operational parameters that increase the probability of clogging, as well as a method to systematically triage drug product formulations based on their clogging probability. Based on these insights, we illustrate how simulations can be leveraged to effectively design prefilled syringes to minimize clogging probabilities for a given drug product formulation.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"79 2","pages":"238-239"},"PeriodicalIF":0.0,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144079451","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

Nitrogen Dioxide Sterilization is a New State-of-the-Art Sterilization Technology to Control Contamination Risks From Your Prefilled Devices and Combination Drug Products. 二氧化氮灭菌是一种新的最先进的灭菌技术，用于控制预灌装设备和组合药品的污染风险。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2025-05-14 DOI: 10.5731/pdajpst.2025.25205

Annick Gillet, Aaron DeMent, Erik Haghedooren, Eric Offermann, Ross Tsakas

引用次数: 0