PDA Journal of Pharmaceutical Science and Technology最新文献

{"title":"A Risk-Based Approach for Managing Affinity Resin Contaminations.","authors":"Beth Fulton,&nbsp;Angelica Welch","doi":"10.5731/pdajpst.2022.012814","DOIUrl":"10.5731/pdajpst.2022.012814","url":null,"abstract":"<p><p>This commentary outlines a proposed approach for navigating remediation (non-routine sanitization) of contaminated affinity-based resins. The methodology for collection of relevant information and for subsequent decision-making is presented, along with a tool for determining risk to the process associated with proposed return-to-use of remediated resin.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":" ","pages":"420-435"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9779584","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":"Ridding the World of 'Rogues': Improving Vapor-Phase H₂O₂ Sterilization and Decontamination Processes.","authors":"Jim Agalloco","doi":"10.5731/pdajpst.2021.012727","DOIUrl":"10.5731/pdajpst.2021.012727","url":null,"abstract":"This publication reviews the reported 'rogue' behavior of biological indicators used for vapor phase hydrogen peroxide processes with attention to the aspects of BI design / configuration to identify factors which may contribute to the reported greater variance in resistance. The contributing factors are reviewed with respect to the unique circumstances of a vapor phase process that adds challenges to H2O2 delivery to the spore challenge. The numerous complexities of H2O2 vapor phase processes are described as these contribute to the difficulties encountered. The paper includes specific recommendations for changes to the biological indicator configurations in use and the vapor process to reduce the incidence of rogues.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":" ","pages":"412-419"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9463446","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 Use of Amplified ATP Bioluminescence for Rapid Sterility Testing of Drug Product Formulations.","authors":"Miriam Guest,&nbsp;Benjamin Pickard,&nbsp;Benjamin Smith,&nbsp;Sophie Drinkwater","doi":"10.5731/pdajpst.2022.012762","DOIUrl":"10.5731/pdajpst.2022.012762","url":null,"abstract":"<p><p>The use of amplified adenosine trisphosphate (ATP) bioluminescence has been established within AstraZeneca as a technique for assessing the sterility of drug product formulations. A platform validation was generated that challenged the technology with a range of organisms and inoculum levels, and the approach to onboarding additional drug products has been designed to maximize the understanding of the drug product behavior when samples may be limited during the development phases of the life cycle of a drug product. Many activities to support sterility assurance take place during product development. However, sterile material manufactured under Good Manufacturing Practice (GMP) conditions may not always be available, for example, during studies to understand the bacterial retention of sterilizing grade filters. In cases of bactericidal products, the use of surrogates may be justified if they are suitably representative of the final drug product formulation. It may not be possible to secure GMP facility access to prepare such surrogate formulations; in those cases, the principles of GMP may be applied in a controlled laboratory setting. The rapid sterility test was used to provide the sterility assurance of the prepared surrogate material. In this case study, the application of amplified ATP bioluminescence sterility testing enabled a fast response to ensure mitigations could be executed in a timely manner. This meant that overarching project plans could be met. The case study also provides information on the rapid identification technique used to identify the slow growing and difficult to recover organism, which allowed faster indication of a nonsterile material. The example also highlights some of the aspects of the challenges of culturing microorganisms and the value of modern techniques in their ability to indicate a quality drift. <i>Dermacoccus nishinomiyaensis</i> was isolated from the test article, and throughout the investigation, it was not possible to culture this organism on standard tryptic soya agar.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":" ","pages":"402-411"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9639942","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":"Vaccine Disparities and Sustainable Development Goals.","authors":"Shanker Gupta","doi":"10.5731/pdajpst.2023.001623","DOIUrl":"10.5731/pdajpst.2023.001623","url":null,"abstract":"","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"77 5","pages":"339"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41141377","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":"Applying Machine Learning to the Visual Inspection of Filled Injectable Drug Products.","authors":"Romain Veillon,&nbsp;John Shabushnig,&nbsp;Lars Aabye-Hansen,&nbsp;Matthieu Duvinage,&nbsp;Christian Eckstein,&nbsp;Zheng Li,&nbsp;Andrea Sardella,&nbsp;Manuel Soto,&nbsp;Jorge Delgado Torres,&nbsp;Brian Turnquist","doi":"10.5731/pdajpst.2022.012796","DOIUrl":"10.5731/pdajpst.2022.012796","url":null,"abstract":"<p><p>With machine learning (ML), we see the potential to better harness the intelligence and decision-making abilities of human inspectors performing manual visual inspection (MVI) and apply this to automated visual inspection (AVI) with the inherent improvements in throughput and consistency. This article is intended to capture current experience with this new technology and provides points to consider for successful application to AVI of injectable drug products. The technology is available today for such AVI applications. Machine vision companies have integrated ML as an additional visual inspection tool with minimal upgrades to existing hardware. Studies have demonstrated superior results in defect detection and reduction in false rejects, when compared with conventional inspection tools. ML implementation does not require modifications to current AVI qualification strategies. The utilization of this technology for AVI will accelerate recipe development by use of faster computers rather than by direct human configuration and coding of vision tools. By freezing the model developed with artificial intelligence tools and subjecting it to current validation strategies, assurance of reliable performance in the production environment can be achieved.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":" ","pages":"376-401"},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9639943","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":"Headache in Hemangioblastomas: A Histopathology and Structural","authors":"Ali Reza Arabestanino, Arman Ai, Sina Naghibi Irvani, Mahdiar Mahmoodi, Mohammad Matin Chaboki, Bita Dinarvand","doi":"10.11648/j.pst.20230701.12","DOIUrl":"https://doi.org/10.11648/j.pst.20230701.12","url":null,"abstract":"","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"28 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72525551","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":"Comparison of Vanco Ready® Vancomycin Injection Premix with Lyophilized Vancomycin Products in a Simulated Compounding & Clinical Setting","authors":"Alexander James Sperry, J. Cruikshank, H. Hoang, Kato Nichols, George Edward MacKinnon III, Nashaat Zakaria Gerges, Abhay Singh Chauhan","doi":"10.11648/j.pst.20230701.13","DOIUrl":"https://doi.org/10.11648/j.pst.20230701.13","url":null,"abstract":"","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"24 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84765518","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":"Characterization of a Novel Particle in a Pharmaceutical Drug Product.","authors":"Stephanie Moore,&nbsp;Peter Masatani,&nbsp;Yasser Nashed-Samuel,&nbsp;Gianni Torraca,&nbsp;Michael Akers,&nbsp;Jeremy Gastwirt,&nbsp;Chakradhar Padala,&nbsp;David Semin","doi":"10.5731/pdajpst.2021.012686","DOIUrl":"https://doi.org/10.5731/pdajpst.2021.012686","url":null,"abstract":"<p><p>A previously unreported particle type was observed during routine visual vial inspection of a liquid drug product and suspected to be the result of vial delamination. Delamination is the corrosive attack on the interior surface of a glass container resulting in the release of thin flake-like glass particles, lamellae, into solution. It is a major concern for pharmaceutical companies, especially for parenteral solutions, and drug programs with a high risk for delamination are typically monitored for lamellae formation through long-term stability studies. Although these particles observed resembled lamellae (i.e., thin, reflecting light, buoyant) they were not the result of glass delamination. In this study, the authors describe a previously unreported particle type and provide a detailed comparison with known lamellae exposed to the same drug formulation. The chemical, elemental, and morphological characteristics of the particles and respective vials are described in detail. Overall, the particles' high organic and low silica elemental signature, along with no signs of delamination on the glass vial inner surface demonstrate that this lamellae-like observation is a novel particle form that can be distinguished from lamellae formed from vial glass delamination.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"77 4","pages":"254-267"},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9966986","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":"Design, Development, and Validation of a Culture-Independent Nucleic Acid Diagnostics Method for the Rapid Detection and Quantification of the <i>Burkholderia cepacia</i> Complex in Water with an Equivalence to ISO/TS 12869:2019.","authors":"Huong Thu Duong,&nbsp;Shannon Fullbrook,&nbsp;Kate Reddington,&nbsp;Elizabeth Minogue,&nbsp;Thomas Barry","doi":"10.5731/pdajpst.2021.012728","DOIUrl":"10.5731/pdajpst.2021.012728","url":null,"abstract":"<p><p>In the wake of a series of outbreaks of finished pharmaceutical product-related <i>Burkholderia cepacia</i> complex (Bcc) human infections worldwide, the United States Food and Drug Administration (FDA) in 2017, and subsequently in 2021, issued advisory notifications to the pharmaceutical industry for stringent Bcc testing requirements for pharmaceutical manufacturing processes and for finished pharmaceutical products prior to release to the marketplace. The advisory notifications highlight non-sterile aqueous finished pharmaceutical products as being a major culprit associated with many of these human infection events. As such, there has been a significant number of Bcc-contaminated finished product recalls resulting in company revenue losses, delayed finished product release, finished product shortages for patients, and manufacturing plant shutdowns coupled with company reputational damage. With many of the finished product recall events, pharmaceutical grade water and/or manufacturing facility water distribution systems were identified as the primary origin source of Bcc contamination. Testing and monitoring regimes currently employed to identify Bcc contamination of water associated with pharmaceutical manufacturing are often limited by costly, laborious, lengthy, and nonspecific traditional microbial culture-based methodologies. Presently FDA approved, European Conformity (CE) marked, and International Organization for Standardization (ISO) standard microbial culture-independent rapid, quantitative, specific, and sensitive nucleic acid diagnostics (NAD) methodologies are now gaining greater widespread acceptance in their routine usage in testing laboratories. Here we present the development of a rapid (<4 hours from sample in to result out) single test culture-independent Bcc NAD method, incorporating a quantitative real-time polymerase chain reaction (qPCR) assay. This method can be used for the detection and simultaneous identification of all 24 Bcc species currently assigned, directly from water samples. This culture-independent Bcc NAD method is validated to the testing method equivalent of the ISO/TS 12869:2019 standard, which is a widely used rapid culture-independent NAD method for detecting Gram-negative <i>Legionella</i> species in water.</p>","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"77 4","pages":"296-310"},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9967025","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":"2023 PDA Advanced Therapy Medicinal Products Conference.","authors":"Shanker Gupta","doi":"10.5731/pdajpst.2023.001523","DOIUrl":"https://doi.org/10.5731/pdajpst.2023.001523","url":null,"abstract":"","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"77 4","pages":"253"},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9980012","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}