Guide to Cell Therapy GxP

Guide to Cell Therapy GxP is a practical guide to the implementation of quality assurance systems for the successful performance of all cell-based clinical trials. The book covers all information that needs to be included in investigational medicinal product dossier (IMPD), the launching point for any clinical investigation, and beyond. Guide to Cell Therapy GxP bridges a knowledge gap with the inclusion of examples of design of GLP-compliant preclinical studies; design of bioprocesses for autologous/allogeneic therapies; and instruction on how to implement GLP/GMP standards in centers accredited with other quality assurance standards. Guide to Cell Therapy GxP is an essential resource for scientists and researchers in hospitals, transfusion centers, tissue banks, and other research institutes who may not be familiar with the good scientific practice regulations that were originally designed for product development in corporate environments. This book is also a thorough resource for PhD students, Post-docs, Principal Investigators, Quality Assurance Units, and Government Inspectors who want to learn more about how quality standards are implemented in public institutions developing cell-based products. . Easy access to important information on current regulations, state-of-the-art techniques, and recent advances otherwise scattered on various funding websites, within conference proceedings, or maintained in local knowledge. . Features protocols, techniques for trouble-shooting common problems, and an explanation of the advantages and limitations of a technique in generating conclusive data. . Includes practical examples of successful implementation of quality standards.

Produk Detail:

  • Author : Joaquim Vives
  • Publisher : Academic Press
  • Pages : 266 pages
  • ISBN : 9780128031155
  • Rating : 4/5 from 21 reviews
CLICK HERE TO GET THIS BOOKGuide to Cell Therapy GxP

Guide to Cell Therapy GxP

Guide to Cell Therapy GxP
  • Author : Joaquim Vives,Gloria Carmona
  • Publisher : Academic Press
  • Release : 30 July 2015
GET THIS BOOKGuide to Cell Therapy GxP

Guide to Cell Therapy GxP is a practical guide to the implementation of quality assurance systems for the successful performance of all cell-based clinical trials. The book covers all information that needs to be included in investigational medicinal product dossier (IMPD), the launching point for any clinical investigation, and beyond. Guide to Cell Therapy GxP bridges a knowledge gap with the inclusion of examples of design of GLP-compliant preclinical studies; design of bioprocesses for autologous/allogeneic therapies; and instruction on

Guide to Cell Therapy GxP

Guide to Cell Therapy GxP
  • Author : Joaquim Vives,Gloria Carmona
  • Publisher : Academic Press
  • Release : 24 July 2015
GET THIS BOOKGuide to Cell Therapy GxP

Guide to Cell Therapy GxP is a practical guide to the implementation of quality assurance systems for the successful performance of all cell-based clinical trials. The book covers all information that needs to be included in investigational medicinal product dossier (IMPD), the launching point for any clinical investigation, and beyond. Guide to Cell Therapy GxP bridges a knowledge gap with the inclusion of examples of design of GLP-compliant preclinical studies; design of bioprocesses for autologous/allogeneic therapies; and instruction on

Cell Therapy

Cell Therapy
  • Author : Adrian Gee
  • Publisher : Springer
  • Release : 03 December 2014
GET THIS BOOKCell Therapy

Cell Therapy: cGMP Facilities and Manufacturing is the source for a complete discussion of facility design and operation with practical approaches to a variety of day-to-day activities, such as staff training and competency, cleaning procedures, and environmental monitoring. This in-depth book also includes detailed reviews of quality, the framework of regulations, and professional standards. It meets a previously unmet need for a thorough facility-focused resource, Cell Therapy: cGMP Facilities and Manufacturing will be an important addition to the cell therapy

Research Methods for Student Radiographers

Research Methods for Student Radiographers
  • Author : Christopher M. Hayre,Xiaoming Zheng
  • Publisher : CRC Press
  • Release : 28 September 2021
GET THIS BOOKResearch Methods for Student Radiographers

This book provides an holistic picture of the application of research in radiography and focuses on multivariant methodological approaches and practices. It will provide readers insight into both contemporary and innovative methods within radiography research, backed up with evidence-based literature. This book may also be translated into other health disciplines as it introduces research to the reader by detailing terms that can often be confusing for students. These remain central in understanding the importance of research in radiography and how

Regulatory Aspects of Gene Therapy and Cell Therapy Products

Regulatory Aspects of Gene Therapy and Cell Therapy Products
  • Author : Maria Cristina Galli,Mercedes Serabian
  • Publisher : Springer
  • Release : 15 September 2015
GET THIS BOOKRegulatory Aspects of Gene Therapy and Cell Therapy Products

This book discusses the different regulatory pathways for gene therapy (GT) and cell therapy (CT) medicinal products implemented by national and international bodies throughout the world (e.g. North and South America, Europe, and Asia). Each chapter, authored by experts from various regulatory bodies throughout the international community, walks the reader through the applications of nonclinical research to translational clinical research to licensure for these innovative products. More specifically, each chapter offers insights into fundamental considerations that are essential for

Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy

Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy
  • Author : Mahmoud Aljurf,John A. Snowden,Patrick Hayden,Kim H. Orchard,Eoin McGrath
  • Publisher : Springer Nature
  • Release : 18 April 2021
GET THIS BOOKQuality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy

This open access book provides a concise yet comprehensive overview on how to build a quality management program for hematopoietic stem cell transplantation (HSCT) and cellular therapy. The text reviews all the essential steps and elements necessary for establishing a quality management program and achieving accreditation in HSCT and cellular therapy. Specific areas of focus include document development and implementation, audits and validation, performance measurement, writing a quality management plan, the accreditation process, data management, and maintaining a quality management

EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP

EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP
  • Author : Orlando Lopez
  • Publisher : CRC Press
  • Release : 06 April 2015
GET THIS BOOKEU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP

Good Manufacturing Practice (GMP) ensures medicinal products are produced consistently and controlled to the quality standards appropriate for their intended use and as required by product specifications or marketing authorization. Annex 11 details the European Medicines Agency (EMA) GMP requirements for computer systems.The purpose of Annex 11 is

Good Research Practice in Non-Clinical Pharmacology and Biomedicine

Good Research Practice in Non-Clinical Pharmacology and Biomedicine
  • Author : Anton Bespalov,Martin C. Michel,Thomas Steckler
  • Publisher : Springer Nature
  • Release : 01 January 2020
GET THIS BOOKGood Research Practice in Non-Clinical Pharmacology and Biomedicine

This open access book, published under a CC BY 4.0 license in the Pubmed indexed book series Handbook of Experimental Pharmacology, provides up-to-date information on best practice to improve experimental design and quality of research in non-clinical pharmacology and biomedicine.

Guide to the Quality and Safety of Tissues and Cells for Human Application

Guide to the Quality and Safety of Tissues and Cells for Human Application
  • Author : European Directorate for the Quality of Medicines & Healthcare
  • Publisher : Unknown Publisher
  • Release : 11 October 2013
GET THIS BOOKGuide to the Quality and Safety of Tissues and Cells for Human Application

This guide provides state-of-the-art information in order to maximise the quality and minimise the risks during donation, procurement, testing, processing, preservation, storage and distribution of tissues and cells. As with all transplanted material of human origin, tissues and cells carry risks of disease transmission, which must be controlled by the application of scrupulous donor selection criteria (including testing) and comprehensive quality systems. The idea behind this guide is to help professionals on a practical level by providing generic guidance that

Pharmaceutical Computer Systems Validation

Pharmaceutical Computer Systems Validation
  • Author : Guy Wingate
  • Publisher : CRC Press
  • Release : 19 April 2016
GET THIS BOOKPharmaceutical Computer Systems Validation

Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews r

Handbook

Handbook
  • Author : World Health Organization
  • Publisher : World Health Organization
  • Release : 02 February 2010
GET THIS BOOKHandbook

A new edition of one of Zola's lesser-known novels from the Rougon-Macquart Cycle Finding the young Angélique on their doorstep one Christmas Eve, the pious Hubert couple decide to bring her up as their own. As the girl grows up in the vicinity of the town's towering cathedral and learns her parents' trade of embroidery, she becomes increasingly fascinated by the lives of the saints, a passion fueled by her reading of the Golden Legend and other mystical Christian

A Concise Guide to Clinical Trials

A Concise Guide to Clinical Trials
  • Author : J. Rick Turner
  • Publisher : Unknown Publisher
  • Release : 01 September 2011
GET THIS BOOKA Concise Guide to Clinical Trials

Biopharmaceutical drugs improve the health and well-being of people across the globe on a scale that is unrivaled by any other medical intervention. Before these drugs can be prescribed for patients by their doctors, they have to be approved for marketing by a regulatory agency. To gain marketing approval, drugs must go through an extremely rigorous process that investigates their safety and efficacy, the process of New Drug Development. The last stage of this long, complex, and expensive process involves

WHO Expert Committee on Specifications for Pharmaceutical Preparations

WHO Expert Committee on Specifications for Pharmaceutical Preparations
  • Author : World Health Organization
  • Publisher : World Health Organization
  • Release : 15 May 2019
GET THIS BOOKWHO Expert Committee on Specifications for Pharmaceutical Preparations

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: Procedure for development of the WHO medicines quality assurance guidelines; Guidelines on Good Manufacturing Practices (GMP) for heating, ventilation and air-conditioning systems (HVAC) illustrative part; Guidance on GMP for Validation, including the general