PDA Journal of Pharmaceutical Science and Technology最新文献

{"title":"The Role of Microbiologists in Drug Product Development.","authors":"Donald C Singer, Deborah D Gross, Anthony M Cundell","doi":"10.5731/pdajpst.2025-000010.1","DOIUrl":"https://doi.org/10.5731/pdajpst.2025-000010.1","url":null,"abstract":"<p><p>The role of the microbiologist during product development of medicines ensures patient safety during clinical trials and also the continuation of microbial control through commercialization of the new product. Microbiological expertise, insight, and cGMP input for new product development is needed for formulation, manufacturing, packaging and monitoring, plus testing of in-process materials, finished dosage form and stability. Risk assessment and evaluation of potential microbial contamination origin(s) support a phase-appropriate, broad end-to-end analytical approach to microbiological contamination control strategy. The ultimate beneficiary of this robust oversight and management of quality is the patient. Using knowledge and risk assessment along with experience (of non-sterile and sterile drug product development) provide for a balanced approach to microbiological quality in medicines. This paper will discuss more specific area detail to consider for the role of a microbiologist in non-sterile drug product development.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144102293","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 Risk Based Approach for Pre-Use/Post-Sterilization Integrity Test Simulation During Bacterial Retention Testing as Part of the Process Specific Filter Validation of Sterilizing Grade Filters.","authors":"Mariam Salamatian, Yvonne Gross, Magnus Stering, Thao Le Vinh, Ashira Bindels","doi":"10.5731/pdajpst.2024.012990","DOIUrl":"https://doi.org/10.5731/pdajpst.2024.012990","url":null,"abstract":"<p><p>Pre-Use Post Sterilization Integrity Testing is implemented in sterile filtration applications by drug manufacturers using a risk-based approach with consideration of the stipulation in Eudralex volume 4, Annex 1, of the European Union Good Manufacturing Practice for Sterile Products' which states that ″The integrity of the sterilizing filter should be verified before use″ (1). Within the bacterial retention test design, performed as part of the process-specific sterile filter validation, it is important to simulate the filtration process under evaluation as closely as possible. Worst-case conditions experienced by the process filter during routine use that may impact the process filters' ability to produce a sterile effluent should be accounted for in the study. As performing pre-use post sterilization integrity testing introduces additional mechanical stress on the process filter and a new potential route for the introduction of bioburden into the process fluid flow path related to the filter wetting procedure, a risk-based bacterial retention test design incorporating a pre-use post sterilization integrity testing simulation phase, should be considered after a thorough evaluation of the process specific conditions. The risk assessment should include evaluation of process pre-use post sterilization integrity testing conditions including but not limited to the integrity test method and specifications, the wetting fluid type, the maximum allowable number of pre-use post sterilization integrity test repetitions as well as the permitted bioburden level of the pre-use post sterilization integrity testing wetting fluid. The outcome of the assessment provides a basis for the process specific bacterial retention test design. In the following we present our perspective on the topic as well as detailed insight into various aspects of pre-use post sterilization integrity testing simulation test design for consideration.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144102291","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 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":"<p><p>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.</p>","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}

{"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":"<p><p><i>In silico</i> 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 <i>in silico</i> 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.</p>","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}

{"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":"<p><p>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.</p>","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}

{"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":"<p><p>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 <i>The Circular Economy</i>, 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.</p>","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}

{"title":"Quality Assurance.","authors":"","doi":"10.5731/pdajpst.2025.001942","DOIUrl":"https://doi.org/10.5731/pdajpst.2025.001942","url":null,"abstract":"","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"79 2","pages":"123-124"},"PeriodicalIF":0.0,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144079541","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":"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":"<p><p>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.</p>","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}

{"title":"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.","authors":"Sebastian Muenscher","doi":"10.5731/pdajpst.2025.25207","DOIUrl":"https://doi.org/10.5731/pdajpst.2025.25207","url":null,"abstract":"<p><p>RFID technology is mainstream in retail where apparel is tracked and inventory is managed with digital reader systems. All items at e.g. Walmart, Nordstrom and H&M are equipped with an RFID tag. Thus, warehouse managers and sales staff have full visibility on the movement and availability of items. The pharma industry is starting to follow this trend.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"79 2","pages":"248-249"},"PeriodicalIF":0.0,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144079447","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 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":"<p><p>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.</p>","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}