PDA Journal of Pharmaceutical Science and Technology最新文献_第4页

From Bench to Reality: The Role of Natural Contaminations in LER Investigations: Poster presented at PDA Microbiology Conference 2025. 从工作台到现实：自然污染在LER调查中的作用：海报呈现在PDA微生物会议2025。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-02-28 DOI: 10.5731/pdajpst.2026.26128

Alessandro Pauletto, Christian Faderl, Luca Di Bello, Gregory Devulder, Kevin L Williams

引用次数: 0

Alternative Methods in Microbial QC: Evaluating the Use of the ATCC MicroQuant™ as a Ready-To-Use Commercial Reference Microorganism Preparation on the Growth Direct® System: Poster Presented at PDA Microbiology Conference 2025. 微生物质量控制的替代方法：评估ATCC MicroQuant™作为即用型商业参考微生物制剂在Growth Direct®系统上的使用：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.2026.26140

Shravani Tadepalli, Anita Takock, Jyoti Jha, Rahul Tevatia, Aditi Patel, Nilay Chakraborty, Owen Griffin

{"title":"Alternative Methods in Microbial QC: Evaluating the Use of the ATCC MicroQuant™ as a Ready-To-Use Commercial Reference Microorganism Preparation on the Growth Direct® System: Poster Presented at PDA Microbiology Conference 2025.","authors":"Shravani Tadepalli, Anita Takock, Jyoti Jha, Rahul Tevatia, Aditi Patel, Nilay Chakraborty, Owen Griffin","doi":"10.5731/pdajpst.2026.26140","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26140","url":null,"abstract":"In the pharmaceutical industry, maintaining the highest standards of microbial Quality Control (QC) is critical to ensure safety and efficiency of pharmaceutical products. Precisely quantified reference microbial standards play a vital role in validating alternative microbiological methods by ensuring accurate, consistent, and reproducible results.This study evaluates the use and performance of ATCC MicroQuant™ reference material with the Growth Direct® System EM and Bioburden applications, showcasing an alternative approach to traditional microbial QC.The audience will benefit by gaining insights into how the ATCC MicroQuant™ can be a precise ready-to-use reference standard that pairs well with the Growth Direct® System. This poster highlights the benefits of a precisely quantitated reference standards when validating alternative microbiological methods such as the Growth Direct® System.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 1","pages":"201-202"},"PeriodicalIF":0.0,"publicationDate":"2026-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147321929","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

Demystifying Low Endotoxin Recovery (LER): Poster presented at PDA Microbiology Conference 2025. 揭秘低内毒素回收（LER）：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.2026.26105

Allen Burgenson

{"title":"Demystifying Low Endotoxin Recovery (LER): Poster presented at PDA Microbiology Conference 2025.","authors":"Allen Burgenson","doi":"10.5731/pdajpst.2026.26105","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26105","url":null,"abstract":"Low Endotoxin Recovery (LER) is described as the inability to recover a known concentration of Control Standard Endotoxin (CSE), or Reference Standard Endotoxin (RSE) over time. It is a two-part reaction requiring a chelator and a surfactant. The chelator strips away the divalent cations causing the LPS aggregate to disassemble. Since Lipid A of LPS is hydrophobic, polysorbate encapsulates the LPS in a lipid micelle. This form of endotoxin is unable to react with Factor C of the Limulus Amebocyte Lysate.The FDA and EMA require all new biologic drugs submitted for approval to be assessed for the presence of the LER phenomenon.Organisms used to produce RSE/CSE standards are grown under high nutrient conditions including divalent cations, then purified. The divalent cations allow the organisms to develop \"salt bridges\" between adjacent lipopolysaccharide molecules. However, organisms in purified water systems are not exposed to divalent cations in their environment and adapt to this environment via the PhoP/PhoQ system on the bacterial surface, holding the outer membrane together. These adapted organisms' endotoxin is not affected by the chelator, and the aggregates remain intact. This is the endotoxin that will contaminate the product if a breach in the water purification system happens.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 1","pages":"129-130"},"PeriodicalIF":0.0,"publicationDate":"2026-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147321979","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

Considerations for Designing a Microbial Challenge Study: Poster Presented at PDA Microbiology Conference 2025. 设计微生物挑战研究的考虑因素：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.2026.26145

Randy Wolford, Samantha Chang

{"title":"Considerations for Designing a Microbial Challenge Study: Poster Presented at PDA Microbiology Conference 2025.","authors":"Randy Wolford, Samantha Chang","doi":"10.5731/pdajpst.2026.26145","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26145","url":null,"abstract":"As the pharmaceutical industry continually evolves, so do regulatory requirements for biological products and establishing in-use hold times for products in a clinical setting. Although adapted from USP Chapter <51>, microbial challenge studies are non-compendial studies that evaluate the microbial growth potential of a product spiked with a low level of microorganisms to simulate inadvertent contamination during dose preparation.Microbial challenge studies provide information on how long drug products can be held before patient safety is at risk, the effectiveness of any preservatives and/or preservative ingredients, optimum storage conditions, and ultimately, if the drug product formulation can withstand low level contamination. If microorganisms can grow in the product during the holding period, then the intended hold time, product formulation, or storage conditions should be reevaluated.When designing a microbial challenge study, multiple factors should be considered. This includes, but is not limited to, the inherent characteristics of the drug product formulation, the storage condition(s) of the drug product, target organisms (i.e., organisms prevalent in a hospital setting), diluents, and testing time points dictated by intended hold time.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 1","pages":"211-212"},"PeriodicalIF":0.0,"publicationDate":"2026-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147322063","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

PDA JPST's 2025 Outstanding Reviewers. PDA JPST的2025杰出评审员。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-02-28 DOI: 10.5731/pdajpst.2026-012026

引用次数: 0

Emerging Role of Regulatory Intelligence in Biotechnology: An Integrated Literature Review of Strategic Compliance and Innovation Framework. 监管智能在生物技术中的新兴作用：战略合规与创新框架的综合文献综述。

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-02-28 DOI: 10.5731/pdajpst.2025-000034.1

Mara Girgis, Immanuel Jason Victor, Leonardo Tavormina, Nigel D Reed, Jason Kerr

{"title":"Emerging Role of Regulatory Intelligence in Biotechnology: An Integrated Literature Review of Strategic Compliance and Innovation Framework.","authors":"Mara Girgis, Immanuel Jason Victor, Leonardo Tavormina, Nigel D Reed, Jason Kerr","doi":"10.5731/pdajpst.2025-000034.1","DOIUrl":"10.5731/pdajpst.2025-000034.1","url":null,"abstract":"Regulatory intelligence (RI) is an emerging and increasingly fundamental function within regulatory affairs, particularly in the biotechnology sector. Defined by its focus on the systematic collection, analysis, and dissemination of regulatory information, RI supports informed decision-making and strategic planning in a complex and rapidly evolving regulatory landscape. Despite its growing significance, regulatory intelligence remains underrepresented in the academic literature. This paper seeks to provide a foundational understanding of the discipline by examining the evolving regulatory landscape, the processes involved in regulatory intelligence, and future considerations for its advancement. Data sources include peer-reviewed publications, regulatory authority documents, web-based articles, and industry blog posts. An integrated literature review identified three core components of regulatory intelligence: 1) information collection, 2) information analysis, and 3) information dissemination. The effectiveness of these components is closely linked to the maturity and integration of systems employed by biotechnology organizations. As regulatory frameworks become more dynamic and digital technologies advance, the role of RI will become increasingly central to proactive compliance, innovation strategy, and global market access.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":" ","pages":"47-70"},"PeriodicalIF":0.0,"publicationDate":"2026-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145081310","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: A Comparison Study Between a Recombinant Cascade Reagent and Limulus Amebocyte Lysate: Poster presented at PDA Microbiology Conference 2025. 弥合差距：重组级联试剂和鲎试剂裂解物之间的比较研究：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.2026.26109

Melissa Cramer, Allan J Romberg, Bradley C Parish

{"title":"Bridging the Gap: A Comparison Study Between a Recombinant Cascade Reagent and Limulus Amebocyte Lysate: Poster presented at PDA Microbiology Conference 2025.","authors":"Melissa Cramer, Allan J Romberg, Bradley C Parish","doi":"10.5731/pdajpst.2026.26109","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26109","url":null,"abstract":"For more than 40 years, the Limulus Amebocyte Lysate (LAL) test has served as the standard method for bacterial endotoxin Testing (BET). The critical proteins required for endotoxin detection in LAL assays are sourced from amoebocytes-blood cells extracted from horseshoe crabs.Animal-free reagents have been developed to support conservation efforts and the 3Rs (Replacement, Reduction, and Refinement). One such alternative is the recombinant cascade reagent (rCR), which contains three recombinant proteins that replicate the natural enzymatic cascade found in horseshoe crab amoebocytes to detect bacterial endotoxins.This study assessed the equivalency of rCR to FDA-licensed LAL reagents using 563 pharmaceutically relevant samples. Of these, 134 samples were contaminated with natural environmental endotoxin (NEE), allowing for a direct statistical comparison.Results showed that the rCR assays were equivalent in performance to FDA-licensed LAL assays, detecting endotoxin at similar levels under real-world conditions. Equivalency was demonstrated using methods consistent with those outlined in compendial guidance for bacterial endotoxin testing.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 1","pages":"137-138"},"PeriodicalIF":0.0,"publicationDate":"2026-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147321888","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 Site-Wide Contamination Control Strategy: From Risk Mapping to Implementation: Poster presented at PDA Microbiology Conference 2025. 制定现场污染控制策略：从风险绘图到实施：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.2026.26104

Liz Brockson

引用次数: 0

Development of a Rapid, High-Resolution Microbial Identification Platform: Poster Presented at PDA Microbiology Conference 2025. 一种快速，高分辨率的微生物鉴定平台的发展：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.2026.26144

Andrea Watson, Zachary Pimentel, Giel Göertz, Marcel Hillebrand, Bernice Westrek-Esselink, Julia Maritz, James Cassw

{"title":"Development of a Rapid, High-Resolution Microbial Identification Platform: Poster Presented at PDA Microbiology Conference 2025.","authors":"Andrea Watson, Zachary Pimentel, Giel Göertz, Marcel Hillebrand, Bernice Westrek-Esselink, Julia Maritz, James Cassw","doi":"10.5731/pdajpst.2026.26144","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26144","url":null,"abstract":"The ability to deliver safe medications and vaccines, free of microbial contamination, is dependent on modern methods to identify bacteria that range from biochemical to genotypic in nature. Conventional genotypic methods for bacterial identification generally rely on small parts of the genome, but advancements in DNA sequencing technologies have reduced the time and cost needed to sequence whole genomes. In order to increase resolution in microbial identification and reduce time-to-result compared to conventional methods, we have developed a workflow for rapid identification of bacteria using Oxford Nanopore DNA sequencing that can reconstruct whole genome sequences with >99.8% accuracy to reference sequences. The reconstruction of an entire genome sequence enables high-resolution identification of bacteria. For example, the platform can rapidly differentiate closely related strains of Shigella and E. coli through taxonomic assignment using average nucleotide identity (ANI) and multi-locus sequence typing, and investigations into sub-strain-level differentiation using ANI are ongoing. The analysis of genome data normally requires a highly trained analyst, but work is underway to automate these computational processes as part of Merck's patent-pending ViruScreen platform which enables multi-omic analytical research through an easy-to-use web portal.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 1","pages":"209-210"},"PeriodicalIF":0.0,"publicationDate":"2026-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147321967","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

PDA Journal of Pharmaceutical Science and Technology Pub Date : 2026-02-28 DOI: 10.5731/pdajpst.2026.26103

Alexandra Bezilla

{"title":"Trending Smarter: Unlocking the Hidden Value in EM Data Beyond Alert/Action Limits: Poster presented at PDA Microbiology Conference 2025.","authors":"Alexandra Bezilla","doi":"10.5731/pdajpst.2026.26103","DOIUrl":"https://doi.org/10.5731/pdajpst.2026.26103","url":null,"abstract":"Environmental monitoring (EM) programs have long relied on action and alert limits as the primary drivers for response and investigation. While these regulatory thresholds remain essential (and required), they are not sufficient on their own to provide a complete picture of cleanroom control. This poster challenges the industry's traditional focus on excursions and proposes a more holistic, modern approach to EM data trending-one that aligns with the evolving expectations outlined in EU Annex 1.Key tools such as Contamination Recovery Rate (CRR), percentile-based evaluations, and a combination of methods offer richer insights into process capability, operator consistency, and potential contamination risks-even when results remain within accepted limits. These statistical approaches acknowledge the semi-quantitative nature of microbiological data and accommodate its non-normal distributions more effectively than conventional means and standard deviations.Attendees will gain a deeper understanding of how to integrate these techniques into existing EM programs, transforming environmental data from a compliance checkbox into a meaningful indicator of cleanroom health and performance.","PeriodicalId":19986,"journal":{"name":"PDA Journal of Pharmaceutical Science and Technology","volume":"80 1","pages":"125-126"},"PeriodicalIF":0.0,"publicationDate":"2026-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147322078","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