引导噬菌体作为治疗剂的监管框架和依从性。

IF 2.2 4区 医学 Q4 BIOCHEMISTRY & MOLECULAR BIOLOGY
Shilpa Deshpande Kaistha, Pramila Devi, Nisha Sharma, Sadhana Sagar
{"title":"引导噬菌体作为治疗剂的监管框架和依从性。","authors":"Shilpa Deshpande Kaistha, Pramila Devi, Nisha Sharma, Sadhana Sagar","doi":"10.2174/0113892010347488250113171505","DOIUrl":null,"url":null,"abstract":"<p><p>The emergence of multiple antibiotic resistance in recurrent bacterial infections has led to exploring alternative therapeutic options, including using bacteria lysing viruses [bacteriophages] to control recalcitrant infections. Bacteriophages [Phage] and their end products such as enzymes, virus-like particles, and vectors are being used for varied applications such as basic and applied research for the field of phage therapeutics. Phage-based products and services such as viral vectors for gene therapy/vaccines, imaging agents, diagnostics as well as drug delivery agents form a wide range of useful innovative therapeutics that are under development. Regulatory compliances are hence essential for safely implementing phage in varied applications. Product compliances ensure safety, efficacy, stability, and quality control in preclinical as well as manufacturing and marketing processes. A well-established regulatory framework ensures innovative product development with high rates of successful clinical translation and development of phage therapeutics as effective alternatives to antibiotics or for consideration in integrated pathogen management strategies. This review highlights the importance of regulatory standards in different stages of phage therapy- during preclinical research as well as different regulatory bodies in the manufacturing, clinical evaluation, and market approval of phage-based products. Global trends in facilitating phage therapeutics' regulatory frameworks and compliances are discussed.</p>","PeriodicalId":10881,"journal":{"name":"Current pharmaceutical biotechnology","volume":" ","pages":""},"PeriodicalIF":2.2000,"publicationDate":"2025-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Navigating Regulatory Frameworks and Compliances for Bacteriophages as Therapeutic Agents.\",\"authors\":\"Shilpa Deshpande Kaistha, Pramila Devi, Nisha Sharma, Sadhana Sagar\",\"doi\":\"10.2174/0113892010347488250113171505\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>The emergence of multiple antibiotic resistance in recurrent bacterial infections has led to exploring alternative therapeutic options, including using bacteria lysing viruses [bacteriophages] to control recalcitrant infections. Bacteriophages [Phage] and their end products such as enzymes, virus-like particles, and vectors are being used for varied applications such as basic and applied research for the field of phage therapeutics. Phage-based products and services such as viral vectors for gene therapy/vaccines, imaging agents, diagnostics as well as drug delivery agents form a wide range of useful innovative therapeutics that are under development. Regulatory compliances are hence essential for safely implementing phage in varied applications. Product compliances ensure safety, efficacy, stability, and quality control in preclinical as well as manufacturing and marketing processes. A well-established regulatory framework ensures innovative product development with high rates of successful clinical translation and development of phage therapeutics as effective alternatives to antibiotics or for consideration in integrated pathogen management strategies. This review highlights the importance of regulatory standards in different stages of phage therapy- during preclinical research as well as different regulatory bodies in the manufacturing, clinical evaluation, and market approval of phage-based products. Global trends in facilitating phage therapeutics' regulatory frameworks and compliances are discussed.</p>\",\"PeriodicalId\":10881,\"journal\":{\"name\":\"Current pharmaceutical biotechnology\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":2.2000,\"publicationDate\":\"2025-01-21\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Current pharmaceutical biotechnology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.2174/0113892010347488250113171505\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"BIOCHEMISTRY & MOLECULAR BIOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Current pharmaceutical biotechnology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.2174/0113892010347488250113171505","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"BIOCHEMISTRY & MOLECULAR BIOLOGY","Score":null,"Total":0}
引用次数: 0

摘要

复发性细菌感染中多种抗生素耐药性的出现促使人们探索其他治疗方案,包括使用细菌裂解病毒[噬菌体]来控制难以抵抗的感染。噬菌体及其最终产物,如酶、病毒样颗粒和载体,正被用于各种应用,如噬菌体治疗领域的基础和应用研究。基于噬菌体的产品和服务,如用于基因治疗/疫苗的病毒载体、显像剂、诊断制剂以及药物递送剂,构成了正在开发的一系列有用的创新疗法。因此,法规遵从性对于在各种应用中安全实施噬菌体至关重要。产品合规性确保临床前、生产和销售过程中的安全性、有效性、稳定性和质量控制。完善的监管框架确保创新产品的开发,具有高成功率的临床转化和噬菌体疗法的开发,作为抗生素的有效替代品或在综合病原体管理战略中加以考虑。这篇综述强调了在噬菌体治疗的不同阶段——临床前研究阶段,以及不同监管机构在噬菌体产品的生产、临床评估和市场批准中的重要性。讨论了促进噬菌体治疗的监管框架和依从性的全球趋势。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Navigating Regulatory Frameworks and Compliances for Bacteriophages as Therapeutic Agents.

The emergence of multiple antibiotic resistance in recurrent bacterial infections has led to exploring alternative therapeutic options, including using bacteria lysing viruses [bacteriophages] to control recalcitrant infections. Bacteriophages [Phage] and their end products such as enzymes, virus-like particles, and vectors are being used for varied applications such as basic and applied research for the field of phage therapeutics. Phage-based products and services such as viral vectors for gene therapy/vaccines, imaging agents, diagnostics as well as drug delivery agents form a wide range of useful innovative therapeutics that are under development. Regulatory compliances are hence essential for safely implementing phage in varied applications. Product compliances ensure safety, efficacy, stability, and quality control in preclinical as well as manufacturing and marketing processes. A well-established regulatory framework ensures innovative product development with high rates of successful clinical translation and development of phage therapeutics as effective alternatives to antibiotics or for consideration in integrated pathogen management strategies. This review highlights the importance of regulatory standards in different stages of phage therapy- during preclinical research as well as different regulatory bodies in the manufacturing, clinical evaluation, and market approval of phage-based products. Global trends in facilitating phage therapeutics' regulatory frameworks and compliances are discussed.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
Current pharmaceutical biotechnology
Current pharmaceutical biotechnology 医学-生化与分子生物学
CiteScore
5.60
自引率
3.60%
发文量
203
审稿时长
6 months
期刊介绍: Current Pharmaceutical Biotechnology aims to cover all the latest and outstanding developments in Pharmaceutical Biotechnology. Each issue of the journal includes timely in-depth reviews, original research articles and letters written by leaders in the field, covering a range of current topics in scientific areas of Pharmaceutical Biotechnology. Invited and unsolicited review articles are welcome. The journal encourages contributions describing research at the interface of drug discovery and pharmacological applications, involving in vitro investigations and pre-clinical or clinical studies. Scientific areas within the scope of the journal include pharmaceutical chemistry, biochemistry and genetics, molecular and cellular biology, and polymer and materials sciences as they relate to pharmaceutical science and biotechnology. In addition, the journal also considers comprehensive studies and research advances pertaining food chemistry with pharmaceutical implication. Areas of interest include: DNA/protein engineering and processing Synthetic biotechnology Omics (genomics, proteomics, metabolomics and systems biology) Therapeutic biotechnology (gene therapy, peptide inhibitors, enzymes) Drug delivery and targeting Nanobiotechnology Molecular pharmaceutics and molecular pharmacology Analytical biotechnology (biosensing, advanced technology for detection of bioanalytes) Pharmacokinetics and pharmacodynamics Applied Microbiology Bioinformatics (computational biopharmaceutics and modeling) Environmental biotechnology Regenerative medicine (stem cells, tissue engineering and biomaterials) Translational immunology (cell therapies, antibody engineering, xenotransplantation) Industrial bioprocesses for drug production and development Biosafety Biotech ethics Special Issues devoted to crucial topics, providing the latest comprehensive information on cutting-edge areas of research and technological advances, are welcome. Current Pharmaceutical Biotechnology is an essential journal for academic, clinical, government and pharmaceutical scientists who wish to be kept informed and up-to-date with the latest and most important developments.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信