PDA Journal of Pharmaceutical Science and Technology最新文献_第5页

Evaluating the APAS Independence System for Automated Microbial Detection in Environmental Monitoring: Poster presented at PDA Microbiology Conference 2025. 评估环境监测中自动微生物检测的APAS独立系统：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.2026.26115

Jennifer Hester

{"title":"Evaluating the APAS Independence System for Automated Microbial Detection in Environmental Monitoring: Poster presented at PDA Microbiology Conference 2025.","authors":"Jennifer Hester","doi":"10.5731/pdajpst.2026.26115","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26115","url":null,"abstract":"Automated microbial detection systems are becoming increasingly essential in pharmaceutical manufacturing to enhance efficiency, accuracy, and compliance with Good Manufacturing Practice (GMP) standards. The APAS Independence System, developed by Clever Culture Systems, was evaluated at Bristol Myers Squibb (BMS) to assess its suitability for environmental monitoring applications. The APAS system is capable of automated plate counting of both 55 mm and 90 mm plates, following an offline incubation at routine EM parameters. The study compared APAS automated colony counts to traditional manual counts for compendial strains and environmental monitoring samples across multiple weeks of EM sampling. Performance metrics for both plate sizes were analyzed, such as accuracy, precision, false negative and false positive rates, and robustness. The APAS system demonstrated high accuracy (≥70%) and reliability for most tested organisms. Therefore, the system is being implemented for GMP use, with a validation approach that combines vendor validation of the Artificial Intelligence with site specific instrument qualification. This evaluation provides insight into the capabilities and limitations of automated colony detection, informing future digitalization strategies in microbiological quality control.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 1","pages":"151-152"},"PeriodicalIF":0.0,"publicationDate":"2026-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147321946","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

Data Analysis/Trending/Pattern recognition for Annex 1 Contamination Control Strategy: Poster presented at PDA Microbiology Conference 2025. 附件1污染控制策略的数据分析/趋势/模式识别：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.2026.26107

Susan Cleary

{"title":"Data Analysis/Trending/Pattern recognition for Annex 1 Contamination Control Strategy: Poster presented at PDA Microbiology Conference 2025.","authors":"Susan Cleary","doi":"10.5731/pdajpst.2026.26107","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26107","url":null,"abstract":"The regulations are evolving, for example EMA Annex 1, earlier versions did not mention trends, the current draft version mentions it 23 times. WHO, and FDA also talk about trending, root cause analysis, investigation, and using the data for these purposes. PDA technical report 13, the new revision, even states that automation for data management for environmental mentoring is \"essential\". Trending the data is now a regulatory requirement but what trends should we use, and when? This presentation will include a review of key regulations as they relate to the need to use our data for trending including how often and what events should trigger trending, root cause analysis, and investigations. Also, which trend tools should we use for the different contamination control processes, cut off method, Control charts (Shewhart, etc.), Quantiles, Percentiles, Weibull Distribution, Scatter plot, Regression analysis for slope (upward/downward trends).The last 20 years we have been collecting data and regulations like Annex 11/21 CFR part 11, and more recently the data integrity guidelines, have facilitated that the data is accurate and reliable. Now this regulatory evolution is mandating the use of the data for the betterment of our processes, process control, product quality and patient safety.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 1","pages":"133-134"},"PeriodicalIF":0.0,"publicationDate":"2026-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147322000","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

More Flexible MAT Assay Design by Taking Advantage of Reporter Assay-Based MAT: Poster presented at PDA Microbiology Conference 2025. 利用基于报告分析的MAT更灵活的MAT分析设计：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.2026.26125

Tomohisa Nanao, Yuki Marutani, Tomohiro Mori, Takahiro Nishibu

{"title":"More Flexible MAT Assay Design by Taking Advantage of Reporter Assay-Based MAT: Poster presented at PDA Microbiology Conference 2025.","authors":"Tomohisa Nanao, Yuki Marutani, Tomohiro Mori, Takahiro Nishibu","doi":"10.5731/pdajpst.2026.26125","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26125","url":null,"abstract":"We have developed a next-generation MAT kit based on a reporter assay. In this presentation, we report on the potential for a more flexible MAT test design using our new reagent.In conventional MAT, inflammatory cytokines are typically detected using ELISA as an indicator. In contrast, the LumiMAT pyrogen detection kit detects the transcriptional activity of NF-κB, a transcription factor that induces the expression of inflammatory cytokines, using a luciferase reporter assay. Compared to ELISA-based MAT, the advantages of the reporter assay-based MAT include a significant reduction in cell incubation time due to increased sensitivity (from 24 hours to 3 hours) and the removal of labor-intensive steps (several hours for ELISA to a few minutes for the addition of luminescent substrates).For practical application in pyrogen testing, we conducted preliminary tests in accordance with EP 2.6.30. guidelines on several medicinal products subject to Rabbit Pyrogen Test and confirmed that the results met the requirements specified in the pharmacopoeia. Additionally, our method allows for reduced coefficient of variation, enabling the reduction in the number of replicates (n=4 to n=3) and increasing throughput (from a 96-well plate to a 384-well plate). These features demonstrate the potential for designing more cost-effective test protocols.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 1","pages":"171-172"},"PeriodicalIF":0.0,"publicationDate":"2026-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147322016","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

Rapid Sterility Testing by NAT Method Targeting RNA Instead of DNA: Poster Presented at PDA Microbiology Conference 2025. 在2025年PDA微生物学会议上，利用NAT方法进行RNA而非DNA的快速无菌检测。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-02-28 DOI: 10.5731/pdajpst.2026.26146

Yotaro Yamamoto, Rikiya Kanda, Yukiko Inui, Michiyo Nakamura, Tomohiro Mori, Takahiro Nishibu

{"title":"Rapid Sterility Testing by NAT Method Targeting RNA Instead of DNA: Poster Presented at PDA Microbiology Conference 2025.","authors":"Yotaro Yamamoto, Rikiya Kanda, Yukiko Inui, Michiyo Nakamura, Tomohiro Mori, Takahiro Nishibu","doi":"10.5731/pdajpst.2026.26146","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26146","url":null,"abstract":"We present a rapid sterility testing method targeting ribosomal RNA (rRNA) to enable sensitive and specific detection of microorganisms. The assay follows a simple three-step protocol: (1) activation of microbial cells with concurrent inactivation of DNA, (2) lysis and RNA extraction using magnetic particles, and (3) detection via one-step real-time reverse transcription PCR (RT-PCR). The total assay time is approximately 7 hours. Validation using six compendial organisms listed in USP <71> demonstrated successful detection at a sensitivity of 10 CFU/mL. The method is also compatible with samples containing mammalian cells, maintaining performance in complex matrices. A key feature of this system is the rigorous degradation and removal of residual DNA, effectively reducing the risk of false-positive results that may arise in conventional DNA-targeting assays. By focusing on rRNA, which reflects microbial viability, this method provides a more accurate sterility assessment within a significantly shorter time frame compared to traditional culture-based tests. The approach offers a promising solution for rapid microbiological testing in pharmaceutical quality control and is designed to align with current regulatory expectations for alternative methods.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 1","pages":"213-214"},"PeriodicalIF":0.0,"publicationDate":"2026-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147322155","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

AI Algorithms in the Pharmaceutical Environment: Poster presented at PDA Microbiology Conference 2025. 制药环境中的人工智能算法：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.2026.26122

Lisa Mallam

引用次数: 0

Improving Time to Result: Leveraging Rapid Mycoplasma Detection and Sterility Testing in Cell Therapy Manufacturing: Poster Presented at PDA Microbiology Conference 2025. 改善时间到结果：利用快速支原体检测和无菌测试在细胞治疗制造：海报提交在PDA微生物会议2025。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-02-28 DOI: 10.5731/pdajpst.2026.26142

Sandi True

引用次数: 0

Three-Day Phenotypic Sterility Testing for CGT Manufacturing: Validation of the calScreener+ Platform: Poster presented at PDA Microbiology Conference 2025. CGT生产的三天表型无菌检测：calScreener+平台的验证：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.2026.26127

Wilhelm Paulander, Frida Svanberg Frisinger, Ganna Oliyn

{"title":"Three-Day Phenotypic Sterility Testing for CGT Manufacturing: Validation of the calScreener+ Platform: Poster presented at PDA Microbiology Conference 2025.","authors":"Wilhelm Paulander, Frida Svanberg Frisinger, Ganna Oliyn","doi":"10.5731/pdajpst.2026.26127","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26127","url":null,"abstract":"Sterility testing remains a key bottleneck in the release of cell and gene therapy products (CGTPs), where current compendial methods require up to 14 days, delaying batch release and increasing costs. Symcel's calScreener+ is a novel, commercially available, phenotypic sterility testing system that enables continuous and non-destructive metabolic monitoring via isothermal microcalorimetry, delivering microbial detection results in under three days- offering the fastest reported time-to-detection (TTD) among currently available, growth-based sterility methods evaluated for CGTPs.To demonstrate system applicability, we will present application data showing microbial detection in the presence of high-density eukaryotic cells (106-108 cells/ml), without enrichment or sample processing. This illustrates the method's compatibility with complex, cell-rich matrices typical of CGTPs.The primary focus is validation data from the calScreener+ Three-Day sterility test, covering:Limit of detectionDetection times for fast- and slow-growing organismsSpecificity across 30 relevant microbial speciesComparability to compendial methodsRobustness and ruggedness under varied conditionsA brief overview of the assay workflow will also be included. This method enables earlier contamination detection and supports faster, more efficient batch release-representing a significant advancement for CGT manufacturing.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 1","pages":"175-176"},"PeriodicalIF":0.0,"publicationDate":"2026-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147322068","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

Validating rCR on a Microfluidic Platform: A Multi-Matrix Approach: Poster presented at PDA Microbiology Conference 2025. 在微流控平台上验证rCR：多矩阵方法：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.2026.26132

Meg Provenzano, Jake Vincent

引用次数: 0

Next Generation digital PCR Technology for Sterility Testing of Cell and Gene Therapy Products: Poster presented at PDA Microbiology Conference 2025. 用于细胞和基因治疗产品无菌检测的下一代数字PCR技术：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.2026.26124

Alexandra Müller-Scholz, Lisa Hollstein, Robert Hertel

{"title":"Next Generation digital PCR Technology for Sterility Testing of Cell and Gene Therapy Products: Poster presented at PDA Microbiology Conference 2025.","authors":"Alexandra Müller-Scholz, Lisa Hollstein, Robert Hertel","doi":"10.5731/pdajpst.2026.26124","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26124","url":null,"abstract":"The bio-pharmaceutical world has moved drastically towards short-lived personalized cell and gene therapy products in recent years. With the new quality control requirements, several new rapid microbial detection methods have been developed. USP <1071> states, \"The ability to detect contamination, in real-time, prior to the administration of the short life product may be considered more important than detection of a single colony-forming unit (CFU) in the product.\" However, the new methods strive to detect the holy grail of 1 CFU. Will this ever be possible, or is it even necessary? In this poster, we will present the first digital (droplet) PCR based approach for sterility testing which is intended for testing of cell and gene therapy products, elucidate the critical steps, and highlight the many benefits of this approach. We will address the handling of background signals of a bacteria digital (droplet) PCR experiment and explain how to clearly differentiate between the background and real positive signals. We will demonstrate how the groundbreaking digital (droplet) PCR technology allows a new level of precision in rapid sterility testing. We propose an open discussion on this advanced method and its potential for QC testing and release.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 1","pages":"169-170"},"PeriodicalIF":0.0,"publicationDate":"2026-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147322099","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

Determination of Incubation Time to Detect Microbial Contamination in Compliance with USP <73> Guidelines: Poster presented at PDA Microbiology Conference 2025. 根据USP指南确定检测微生物污染的孵育时间：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.2026.26118

Daniel Kahline, Dana Nutter, Haile Bennett, Stacey Ramsey, Prasanna Khot

{"title":"Determination of Incubation Time to Detect Microbial Contamination in Compliance with USP <73> Guidelines: Poster presented at PDA Microbiology Conference 2025.","authors":"Daniel Kahline, Dana Nutter, Haile Bennett, Stacey Ramsey, Prasanna Khot","doi":"10.5731/pdajpst.2026.26118","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26118","url":null,"abstract":"USP <73> provides risk-based guidelines for the use of adenosine triphosphate (ATP) bioluminescence methods for rapid detection of viable microorganisms for short-life products. ATP bioluminescence detects the presence of viable contamination in less than seven (7) days compared to the required 14-day compendial sterility test. Determining the generation time of the slowest growing microorganism spanning bacteria, yeast and filamentous fungi in the presence of a product helps establish the incubation time of microbial detection. As per USP <73>, inoculum levels for all tested microorganisms were less than 10 CFU. Appropriate enrichment broth and incubation conditions were followed, and product matrices such as mammalian cells and DNA plasmids were evaluated. Samples were filtered with a hollow fiber sampling tip, which captures any bacterial, fungal and yeast cells while removing cellular debris and any non-microbial ATP from the sample being tested. Microbial cells are eluted off the filter and collected in a collection tube for testing with an ATP-bioluminescence method based on the luciferin-luciferase cascade emitting light that is measured with a luminometer. This study demonstrates practical ways of identifying the slowest growing organism, determining generating time, and calculating time to detection, which are all relatively novel concepts for QC Microbiology Testing.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 1","pages":"157-158"},"PeriodicalIF":0.0,"publicationDate":"2026-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147322143","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