PDA Journal of Pharmaceutical Science and Technology最新文献_第7页

Comparison of Three Methods to Determine the "Safety Margin" Used to Determine Final Release Time of Short-Lived Products per USP <72>: Poster presented at PDA Microbiology Conference 2025. 确定短寿命产品最终发布时间的“安全边际”的三种方法的比较：2025年PDA微生物学会议上发表的海报。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-02-28 DOI: 10.5731/pdajpst.2026.26114

Stephanie Hempstead, Jean Claude Raymond, Caroline Kassim Houssenaly

{"title":"Comparison of Three Methods to Determine the \"Safety Margin\" Used to Determine Final Release Time of Short-Lived Products per USP <72>: Poster presented at PDA Microbiology Conference 2025.","authors":"Stephanie Hempstead, Jean Claude Raymond, Caroline Kassim Houssenaly","doi":"10.5731/pdajpst.2026.26114","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26114","url":null,"abstract":"The introduction of USP <72> offers a new regulatory pathway for shortening the release of short-lived pharmaceutical products, including cell and gene therapies, by allowing manufacturers to optimize growth conditions such as media formulation and temperature. The chapter dictates the final time to release is determined by the time to detection (TTD) of the slowest growing organism plus a provided \"safety margin\" formula. This formula relies on calculation of doubling time of the slowest growing microorganism which can be derived by various methods.We evaluated three methods to determine this doubling time: traditional plate enumeration, optical density, and a novel approach using the kinetics of the BACT/ALERT® system. The latter allows estimation of generation time directly from TTD curves based on CO2 production as measured by the BACT/ALERT® system. The benefits of this method include minimal handling time, offering a scalable, practical alternative to traditional methods.We compare all three methods across multiple organisms, including slow-growing anaerobes such as C. acnes, to assess applicability, repeatability, and robustness.The results demonstrate that BACT/ALERT®-based TTD analysis enables precise and efficient safety margin determination, supporting confident, faster release decisions in line with USP <72>.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 1","pages":"149-150"},"PeriodicalIF":0.0,"publicationDate":"2026-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147322039","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

Impact of Species' Diversity in Improving Proteotypic Databases for Microbial Identification: Poster Presented at PDA Microbiology Conference 2025. 物种多样性对改善微生物鉴定蛋白质型数据库的影响：在PDA微生物学会议2025上发表的海报。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-02-28 DOI: 10.5731/pdajpst.2026.26137

Cindy Serrato Zavala, ChloÉ Huyghe, Sujan Timilsina, Bindhu Verghese

{"title":"Impact of Species' Diversity in Improving Proteotypic Databases for Microbial Identification: Poster Presented at PDA Microbiology Conference 2025.","authors":"Cindy Serrato Zavala, ChloÉ Huyghe, Sujan Timilsina, Bindhu Verghese","doi":"10.5731/pdajpst.2026.26137","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26137","url":null,"abstract":"Accurate microbial identification remains a crucial component of quality control and safety in the pharmaceutical industry. Among various methods of microbial identification, proteotypic-based MALDI-TOF (Matrix Assisted Laser Desorption/Ionization Time-of-Flight) technology has emerged as a rapid, high-throughput, and cost-effective method for microbial identification. However, the strength of this method hinges on the robustness and representativeness of the database, particularly its ability to capture intra-species variability. For this study, microbial library entries were generated from microbes isolated from diverse geographic regions to assess the impact of local diversity on identification. Findings showed that identification outcomes by these entries vary by species. For example, approximately 10% of Sphingomonas colocassiae and 13% of Penicillium brevicompactum identifications relied on intra-species geographic diversity entries. Whereas ∼83% of Aspergillus westerdijkiae and ∼78% of Beauveria pseudobassiana identified matched to similar intra-species entries. We further breakdown the impact of these database entries to identify organisms in their regional zone. Notably, regionally sourced entries assist in providing reliable identification for samples in that geographic region. This highlights the relevance of incorporating geographically diverse strains into proteotypic libraries. As microbial diversity varies across manufacturing environments, maintaining comprehensive, regionally representative databases is essential for ensuring accurate identification and effective contamination control.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 1","pages":"195-196"},"PeriodicalIF":0.0,"publicationDate":"2026-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147322055","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

Developing a Comprehensive Organism Panel to Assess the Detection Capabilities of Growth Direct Rapid Sterility for Rapid Sterility Testing: Poster Presented at PDA Microbiology Conference 2025. 开发一个全面的有机体小组来评估生长直接快速无菌的检测能力，用于快速无菌检测：在2025年PDA微生物学会议上发表的海报。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-02-28 DOI: 10.5731/pdajpst.2026.26136

Kayla Sem, Brian Conti, Owen Griffin, Aditi Patel

引用次数: 0

Human Pathogens in Environmental Monitoring: Frequency, Risk, and Tools for Smarter Assessment: Poster presented at PDA Microbiology Conference 2025. 环境监测中的人类病原体：频率、风险和智能评估工具：2025年PDA微生物学会议上发表的海报。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-02-28 DOI: 10.5731/pdajpst.2026.26119

Prasanna Khot, Nick Bielski, Lauren Salvitti

{"title":"Human Pathogens in Environmental Monitoring: Frequency, Risk, and Tools for Smarter Assessment: Poster presented at PDA Microbiology Conference 2025.","authors":"Prasanna Khot, Nick Bielski, Lauren Salvitti","doi":"10.5731/pdajpst.2026.26119","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26119","url":null,"abstract":"Objectionable organisms remain a major threat to pharmaceutical product safety, and among them, human bacterial pathogens stand out for their potential to impact not only product integrity and safety but also manufacturing continuity. Contamination can mean delayed releases, facility shutdowns, and steep financial and reputational costs. In a 5-year global review of over 764,040 EM isolates from 3,300+ sites, more than 800 of the 1,460 known human bacterial pathogens (Bartlett et al., Microbiology 2022;168:001269) were confirmed by DNA sequencing. These findings underscore the frequency - and risk - posed by potentially pathogenic species in manufacturing environments.Curated complementary information such as Risk Group and physiological attributes provide microbiologists with immediate access to essential information for risk assessments. However, such information does not always provide a comprehensive evaluation for assessing pathogenicity. Whole genome sequencing can provide deeper insights into the organism of concern when further characterization is required, especially when screened for genes relevant to preservative resistance, cold sensitivity, pathogenicity, or antimicrobial/disinfectant resistance. This additional testing can improve the quality of risk assessments. This approach enhances environmental control and supports better protection for both products and people.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 1","pages":"159-160"},"PeriodicalIF":0.0,"publicationDate":"2026-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147321913","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

Advanced Microbial Strain Typing Using Whole Genome Sequencing: Poster Presented at PDA Microbiology Conference 2025. 使用全基因组测序的先进微生物菌株分型：在2025年PDA微生物会议上发表的海报。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-02-28 DOI: 10.5731/pdajpst.2026.26141

Sujan Timilsina, Ryan Cox, Ruvim Kolosey, Bindhu Verghese

{"title":"Advanced Microbial Strain Typing Using Whole Genome Sequencing: Poster Presented at PDA Microbiology Conference 2025.","authors":"Sujan Timilsina, Ryan Cox, Ruvim Kolosey, Bindhu Verghese","doi":"10.5731/pdajpst.2026.26141","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26141","url":null,"abstract":"Microbial identification and strain typing are critical in pharmaceutical microbiology for ensuring product safety, controlling contaminants, and meeting regulatory requirements. Traditional strain typing methods like pulsed-field gel electrophoresis and multi-locus sequence typing have their limitations in scalability and resolution. Increased use of next-generation sequencing (NGS) techniques for microbial identification and characterization, coupled with the availability of bacterial whole genomes, advanced sequence analysis approaches such as single nucleotide polymorphisms (SNPs), core and pan-genome analysis, is opening the door for more modern approaches to microbial strain typing. However, several of these approaches are species-specific and require optimization per species or project. In this study, we analyzed conserved genes from several bacterial species to analyze the possibility of using these genes as a set of universal genes for prokaryotic strain typing. We compared the strain typing results using these universal genes to results from species-specific housekeeping genes and with species with no established strain typing methods. Our data demonstrated that these conserved genes successfully distinguished bacterial strains when compared to the results from established species-specific strain typing schemes, providing a path forward in the development of a rapid, universal strain typing solution using bacterial genomes that is not limited to a single species.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 1","pages":"203-204"},"PeriodicalIF":0.0,"publicationDate":"2026-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147321924","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

Establishment of 100GC Mycoplasma Standards Based on Nucleic Acid Amplification Technology According to the Newly Revised European Pharmacopoeia 2.6.7 and the USP <77>: Poster Presented at PDA Microbiology Conference 2025. 根据新修订的欧洲药典2.6.7和USP建立基于核酸扩增技术的100GC支原体标准：在PDA微生物学会议2025上提交的海报

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-02-28 DOI: 10.5731/pdajpst.2026.26143

Dirk Vollenbroich, Matthias Hornschuh, Lisa BÖlck, Lisanne Becker

{"title":"Establishment of 100GC Mycoplasma Standards Based on Nucleic Acid Amplification Technology According to the Newly Revised European Pharmacopoeia 2.6.7 and the USP <77>: Poster Presented at PDA Microbiology Conference 2025.","authors":"Dirk Vollenbroich, Matthias Hornschuh, Lisa BÖlck, Lisanne Becker","doi":"10.5731/pdajpst.2026.26143","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26143","url":null,"abstract":"Mycoplasma contamination is a concern in cell culture or cell culture media during biopharmaceutical manufacturing processes. These impurities pose a safety concern in Advanced Therapy Medicinal Products (ATMPs) due to their small size and resistance to common antibiotics used in cell culture. The minimum required detection limit for mycoplasma detection methods for pharmaceutical products is traditionally defined as 10 colony-forming units (CFU). This definition is based on the classical culture method for detecting and quantifying Mycoplasma. With the advent of novel methods for Mycoplasma detection, which are faster and more reliable, the classical culture method has been superseded by Nucleic Acid Amplification Technology (NAAT). Therefore, the new revised EP 2.6.7 and USP <77> allow mycoplasma detection based on NAAT. Considering this new NAAT-based approach, new validation standards are needed that are based on genomic copies rather than colony-forming units. 100GC mycoplasma standards have been developed according to the revised European Pharmacopoeia 2.6.7, which are quantified using a novel, validated digital PCR assay. This assay offers advantages in accuracy and sensitivity compared to classical real-time PCR.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 1","pages":"207-208"},"PeriodicalIF":0.0,"publicationDate":"2026-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147321961","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

Microbial Detection Efficiency of BFPC Technology versus Conventional Culture-based Microbial Air Recovery Methods for Environmental Monitoring: Poster presented at PDA Microbiology Conference 2025. 环境监测中BFPC技术的微生物检测效率与传统的基于培养的微生物空气回收方法：在2025年PDA微生物会议上发表的海报。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-02-28 DOI: 10.5731/pdajpst.2026.26123

Ellen Moretti

{"title":"Microbial Detection Efficiency of BFPC Technology versus Conventional Culture-based Microbial Air Recovery Methods for Environmental Monitoring: Poster presented at PDA Microbiology Conference 2025.","authors":"Ellen Moretti","doi":"10.5731/pdajpst.2026.26123","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26123","url":null,"abstract":"Lilly is evaluating biofluorescent particulate counting (BFPC) technology to simultaneously replace conventional active and passive (continuous) microbiological air monitoring as well as total non-viable particulate monitoring in Grade A critical filling zones. Microorganisms produce naturally fluorescent compounds, such as riboflavins and NADH, which emit detectable fluorescence when excited by a laser at specific wavelengths. BFPC is a non-culture-based technology specifically designed for real-time detection and quantification of airborne microbes based on excitation/detection of the unique fluorescence given off by those cellular components. Expected benefits implementation include: Enabling real-time discard strategies to reduce sterility assurance riskImproved process knowledge associated with environmental and contamination control.Streamlining of filling line design and monitoring through replacement of all existing conventional microbiological and particulate sampling equipment.Reduced EM media quantities required in Grade A filling zones.Elimination of inherent interventions required to perform passive and active microbiological air monitoring.Improved data integrity for EM sampling results through automation.To establish equivalence/superiority of BFPC, Lilly performed in situ bioaerosol testing to assess the microbial detection efficiencies of BFPC technology versus the recovery efficiencies of conventional culture-based microbial air recovery methods.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 1","pages":"167-168"},"PeriodicalIF":0.0,"publicationDate":"2026-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147321996","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

Designing a CCS that Focuses on Materials Transfer into Cleanrooms, RABS, and Isolators: Poster Presented at PDA Microbiology Conference 2025. 设计一个专注于材料转移到洁净室，RABS和隔离器的CCS：在2025年PDA微生物学会议上发表的海报。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-02-28 DOI: 10.5731/pdajpst.2026.26131

James Polarine

引用次数: 0

Overcoming Biofilm Detection and Mitigation Challenges to Improve Process Control of a Pharmaceutical Water-for-Injection System: Poster presented at PDA Microbiology Conference 2025. 克服生物膜检测和缓解挑战，改善制药注射用水系统的过程控制：在2025年PDA微生物学会议上发表的海报。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-02-28 DOI: 10.5731/pdajpst.2026.26133

Tracy Radcliffe

引用次数: 0

Rapid Mycoplasma Detection Techniques for Facilitating Quality in Low-Volume T-Cell Therapies: Poster presented at PDA Microbiology Conference 2025. 快速支原体检测技术促进小批量t细胞治疗的质量：在2025年PDA微生物会议上发表的海报。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-02-28 DOI: 10.5731/pdajpst.2026.26121

Min Le

{"title":"Rapid Mycoplasma Detection Techniques for Facilitating Quality in Low-Volume T-Cell Therapies: Poster presented at PDA Microbiology Conference 2025.","authors":"Min Le","doi":"10.5731/pdajpst.2026.26121","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26121","url":null,"abstract":"Mycoplasmas, a type of bacteria, are potential contaminants of cell cultures that can be difficult to detect with traditional microbiology methods. Regulatory agencies worldwide require that certain biological products, including cell-based therapies, be tested for mycoplasma contamination to ensure quality and safety.Purpose: Leverage the Applied Biosystems™ MycoSEQ™ Plus Mycoplasma Detection Kit in a cell therapy production workflow, where sample volumes may be limited.Methods: This protocol follows the MycoSEQ Plus mycoplasma detection system, using either 1 or 1.5 mL of the test sample in the qPCR reaction, with manual or automated sample preparation. This leverages the sensitivity guidance of 10 colony forming units (CFU) or genome copy equivalents per mL of test sample.Results: Samples were processed by either Applied Biosystems™ PrepSEQ™ manual or automated express workflows, followed by alcohol precipitation. PCR was performed on the Applied Biosystems™ QuantStudio™ 5 Real-time PCR system.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 1","pages":"163-164"},"PeriodicalIF":0.0,"publicationDate":"2026-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147322138","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