標(biāo)題: Titlebook: Cell Therapy; cGMP Facilities and Adrian P. Gee Book 2022Latest edition Springer Nature Switzerland AG 2022 cell processing facilities.cel [打印本頁] 作者: OBESE 時間: 2025-3-21 16:15
書目名稱Cell Therapy影響因子(影響力)
書目名稱Cell Therapy影響因子(影響力)學(xué)科排名
書目名稱Cell Therapy網(wǎng)絡(luò)公開度
書目名稱Cell Therapy網(wǎng)絡(luò)公開度學(xué)科排名
書目名稱Cell Therapy被引頻次
書目名稱Cell Therapy被引頻次學(xué)科排名
書目名稱Cell Therapy年度引用
書目名稱Cell Therapy年度引用學(xué)科排名
書目名稱Cell Therapy讀者反饋
書目名稱Cell Therapy讀者反饋學(xué)科排名
作者: aptitude 時間: 2025-3-21 21:33 作者: interference 時間: 2025-3-22 03:17
https://doi.org/10.1007/BFb0012355s (cGMP) facilities and bone marrow transplant (BMT) units of two hospitals will be described and discussed. Q-Pulse software has been available for about three decades and is now owned and supported by Ideagen PLC located in the United Kingdom. It also has a head office in the United States.作者: SLAG 時間: 2025-3-22 06:04
Object-Based Distributed Programminge and Genetics (CBG), the Cellular Therapy Production Center, and the Chemical GMP Synthesis Facility. The ultimate aim of these facilities is to produce and test emerging therapeutic innovations in a clinical setting while ensuring patient safety. Here, we focus on the CBG due to its broad experience with different types of biologic products.作者: Small-Intestine 時間: 2025-3-22 11:12
rmation from ethical considerations and facility management .This new edition presents a fully-updated and expanded look at?current Good Manufacturing Practice (cGMP) for?cell therapy products. It provides a complete discussion of?facility design and operation including details specific to?cord bloo作者: adj憂郁的 時間: 2025-3-22 16:20 作者: adj憂郁的 時間: 2025-3-22 20:04
FDA Inspectionsn Cells, Tissues, and Cellular and Tissue-Based products (HCT/Ps) (2). The latter are inspected for current Good Tissue Practices (cGTPs). This chapter recommends procedures to be followed when an audit is performed by a regulatory authority.作者: dendrites 時間: 2025-3-22 21:24
Development and Maintenance of a Quality Programpurity, and potency. This chapter describes the development and maintenance of such a quality program (QP) (Food and Drug Administration. Guide to inspections of quality systems. .. Last accessed 13 July 2020, 1999).作者: 嘲笑 時間: 2025-3-23 04:10 作者: 沒血色 時間: 2025-3-23 07:33
Design and Operation of a Multiuse GMP Facility at the City of Hopee and Genetics (CBG), the Cellular Therapy Production Center, and the Chemical GMP Synthesis Facility. The ultimate aim of these facilities is to produce and test emerging therapeutic innovations in a clinical setting while ensuring patient safety. Here, we focus on the CBG due to its broad experience with different types of biologic products.作者: bile648 時間: 2025-3-23 09:43
G. Di Pillo,L. Grippo,F. Lampariellor medical therapies and studies, and for products. Providing regenerative medicines by strictly complying with applicable regulations is compulsory. In this section, the Japanese regulatory framework for regenerative medicines is briefly described.作者: 監(jiān)禁 時間: 2025-3-23 17:49
Landscape for Regenerative Medicine Manufacturing in Japanr medical therapies and studies, and for products. Providing regenerative medicines by strictly complying with applicable regulations is compulsory. In this section, the Japanese regulatory framework for regenerative medicines is briefly described.作者: grenade 時間: 2025-3-23 22:07 作者: 他很靈活 時間: 2025-3-24 00:23 作者: Ligament 時間: 2025-3-24 05:15
Investigational New Drug Applications for Cell Therapy Productsch. It is important to note that these types of trials are regulated differently throughout the world and that if a study is to be conducted outside of the USA, a thorough review of regulations governing that country will be required. This chapter reviews the process for submitting an Investigational New Drug application to the FDA.作者: 動作謎 時間: 2025-3-24 10:36 作者: HEPA-filter 時間: 2025-3-24 12:28
G. Di Pillo,L. Grippo,F. Lamparielloraised by those offered outside of regulatory frameworks. A discussion of ethical challenges in cell therapy clinical trial design is included. The chapter concludes with ethical considerations pertaining to the procurement and use of pluripotent stem cells: human embryonic stem cells and induced pluripotent stem cells.作者: 放縱 時間: 2025-3-24 15:09 作者: Bouquet 時間: 2025-3-24 20:03 作者: 出生 時間: 2025-3-25 01:46
Springer Nature Switzerland AG 2022作者: 改進 時間: 2025-3-25 07:22 作者: GIDDY 時間: 2025-3-25 09:47
http://image.papertrans.cn/c/image/222885.jpg作者: photopsia 時間: 2025-3-25 15:08
R. A. Klemm,P. A. Lee,T. M. RiceQuality control of cellular therapy products is an essential component of determining their safety and efficacy. This chapter reviews the various components of quality control testing of both cellular therapy products and viral vectors.作者: sundowning 時間: 2025-3-25 18:23 作者: 抵押貸款 時間: 2025-3-25 22:44
Quality Control of Cellular Therapy Products and Viral VectorsQuality control of cellular therapy products is an essential component of determining their safety and efficacy. This chapter reviews the various components of quality control testing of both cellular therapy products and viral vectors.作者: 擋泥板 時間: 2025-3-26 00:13
Introduction: Facility DesignThis chapter provides an introduction to the design of current good manufacturing (cGMP)/good tissue practices (cGTP) facilities in academic institutions. It is followed by separate chapters that provide information on a number of such facilities. In addition, there are chapters on cord blood banks and on a vector production facility.作者: 手術(shù)刀 時間: 2025-3-26 08:13 作者: 精致 時間: 2025-3-26 12:01
Selection of Contract Manufacturing and Testing Organizationsd-alone hospital, wishes to build a cell processing facility to provide the products. An alternative is to use commercial companies for cell processing and/or testing. In recent years, a number of such entities have appeared, and this chapter addresses some of the factors that are involved in selecting those which can meet your needs.作者: 特別容易碎 時間: 2025-3-26 12:54 作者: Dendritic-Cells 時間: 2025-3-26 19:38 作者: 委托 時間: 2025-3-26 23:14 作者: Chagrin 時間: 2025-3-27 01:26
G. Di Pillo,L. Grippo,F. LamparielloMedicine and the Pharmaceuticals, Medical Devices, and Other Therapeutic Products Act?(Revised Pharmaceutical Affairs Act) — as a framework for delivering safe and effective regenerative medicines including cell therapies and cell products to patients as quickly as possible. Both laws regulate thera作者: Oligarchy 時間: 2025-3-27 08:42
K. Iracki,K. Malanowski,S. Walukiewiczping-stone toward the clinical trial in which they are an important and integral part of developing new biomedical products to assess potential risks and safety to human patients. These nonclinical studies must comply with Good Laboratory Practice (GLP) regulations as researchers embrace the changes作者: 使成波狀 時間: 2025-3-27 09:30
G. Di Pillo,L. Grippo,F. Lamparielloraised by those offered outside of regulatory frameworks. A discussion of ethical challenges in cell therapy clinical trial design is included. The chapter concludes with ethical considerations pertaining to the procurement and use of pluripotent stem cells: human embryonic stem cells and induced pl作者: 儀式 時間: 2025-3-27 17:23
Roberto Gonzalez,Edmundo Rofmanast one Institutional Review Board (IRB). Additionally, if the cellular product includes a gene transfer component, the trial will also require review by at least one Institutional Biosafety Committee (IBC). Each of these entities not only requires initial review but also has requirements for ongoin作者: ADORE 時間: 2025-3-27 20:32 作者: 格子架 時間: 2025-3-27 22:59 作者: palliative-care 時間: 2025-3-28 03:17
T. M. Rice,P. A. Lee,R. A. Klemmfor program sustainability. Federal regulations and accrediting agencies require the implementation of a quality program (Code of Federal Regulations, Title 21 CFR part 1271. US Government Printing Office, Washington, DC, 2020. April 2, 2020 .. Last accessed 4 Apr 2020; Code of Federal Regulations, 作者: 蟄伏 時間: 2025-3-28 10:15
T. M. Rice,P. A. Lee,R. A. Klemmring of cell therapy products and vectors. The oversight of these activities falls to the quality assurance group who must devise and maintain an efficient quality program which tracks all aspects of facility operations to ensure that products are prepared under conditions that ensure their safety, 作者: 吵鬧 時間: 2025-3-28 13:05
https://doi.org/10.1007/BFb0012355 and healthcare organizations. Technological advances of these systems provide innovative and efficient solutions for quality management..In this chapter, our experience with implementation and use of Q-Pulse Quality Management Software in the academic setting for current good manufacturing practice作者: originality 時間: 2025-3-28 18:07 作者: bizarre 時間: 2025-3-28 22:42
Object-Based Distributed Programmingcognized the need to bridge the gap between basic discovery research and clinical translation for its own academic researchers and their collaborators. To that end, COH constructed three good manufacturing practices (GMP) compliant facilities over the course of two decades: the Center for Biomedicin作者: 不自然 時間: 2025-3-29 02:34 作者: 古老 時間: 2025-3-29 04:08 作者: 不朽中國 時間: 2025-3-29 11:09
Australian Cellular Therapy Regulations regulatory authority responsible for the regulation of therapeutic goods including medicines, medical devices, and biologicals within Australia. Governed by the . and the ., therapeutic goods imported, exported, manufactured and/or supplied within Australia are required to be listed on the Australi作者: 拱形大橋 時間: 2025-3-29 14:34 作者: SPECT 時間: 2025-3-29 19:19 作者: 干涉 時間: 2025-3-29 22:59 作者: convulsion 時間: 2025-3-30 03:30
Investigational New Drug Applications for Cell Therapy Productsast one Institutional Review Board (IRB). Additionally, if the cellular product includes a gene transfer component, the trial will also require review by at least one Institutional Biosafety Committee (IBC). Each of these entities not only requires initial review but also has requirements for ongoin作者: RECUR 時間: 2025-3-30 04:42
FDA Inspectionsited States. For cells that are more-than-minimally manipulated, the regulations require that manufacturing is performed according to current Good Manufacturing Practices (cGMPs) (1). To ensure compliance the FDA sends out inspectors to audit manufacturers of both cGMP products and producers of Huma作者: PALSY 時間: 2025-3-30 11:59 作者: flutter 時間: 2025-3-30 16:16 作者: PRO 時間: 2025-3-30 19:13 作者: Manifest 時間: 2025-3-31 00:35 作者: Estrogen 時間: 2025-3-31 02:03
Selection of Contract Manufacturing and Testing Organizationsd-alone hospital, wishes to build a cell processing facility to provide the products. An alternative is to use commercial companies for cell processing and/or testing. In recent years, a number of such entities have appeared, and this chapter addresses some of the factors that are involved in select作者: Chronological 時間: 2025-3-31 06:38 作者: Traumatic-Grief 時間: 2025-3-31 11:55 作者: 狂熱文化 時間: 2025-3-31 14:59
R. W. H. Sargent,G. R. Sullivanstent and suitable quality while complying with the legal requirements and regulatory frameworks. New technologies and manufacturing models are emerging to overcome these hurdles and enable scalable and cost-efficient production. In the following sections of this chapter, several aspects with respec作者: 品牌 時間: 2025-3-31 19:40 作者: Cougar 時間: 2025-4-1 00:18
K. Iracki,K. Malanowski,S. Walukiewicze severe. The knowledge of Food and Drug Administration (FDA) regulations is vital for every researcher; this chapter highlights the regulatory knowledge that is essential to perform successful leading-edge research. Any investigator who is interested in conducting GLP studies must perform a needs a
