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 : 0128031166
  • 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 : 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 Science & Business Media
  • Release : 18 September 2009
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

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

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

Stem Cells and Cell Therapy

Stem Cells and Cell Therapy
  • Author : Mohamed Al-Rubeai,Mariam Naciri
  • Publisher : Springer Science & Business Media
  • Release : 01 October 2013
GET THIS BOOKStem Cells and Cell Therapy

With the discovery of stem cells capable of multiplying indefinitely in culture and differentiating into many other cell types in appropriate conditions, new hopes were born in repair and replacement of damaged cells and tissues. The features of stem cells may provide treatment for some incurable diseases with some therapies are already in clinics, particularly those from adult stem cells. Some treatments will require large number of cells and may also require multiple doses, generating a growing demand for generating

Dictionary of Pharmaceutical Medicine

Dictionary of Pharmaceutical Medicine
  • Author : Gerhard Nahler
  • Publisher : Springer Science & Business Media
  • Release : 29 June 2013
GET THIS BOOKDictionary of Pharmaceutical Medicine

This dictionary is aimed primarily at the beginners entering the new discipline of Pharmaceutical Medicine, an area comprising aspects of toxicology, pharmacology, pharmaceutics, epidemiology, statistics, drug regulatory and legal affairs, medicine and marketing. But also more experienced colleagues in departments engaged in clinical development as well as researchers and marketing experts in the pharmaceutical industry will find concise and up-to-date information. The book is completed by a list of a about 1000 abbreviations encountered in pharmaceutical medicine and a compilation of

Regenerative Biology and Medicine

Regenerative Biology and Medicine
  • Author : David L. Stocum
  • Publisher : Academic Press
  • Release : 07 June 2012
GET THIS BOOKRegenerative Biology and Medicine

Regenerative Biology and Medicine, Second Edition — Winner of a 2013 Highly Commended BMA Medical Book Award for Medicine — discusses the fundamentals of regenerative biology and medicine. It provides a comprehensive overview, which integrates old and new data into an ever-clearer global picture. The book is organized into three parts. Part I discusses the mechanisms and the basic biology of regeneration, while Part II deals with the strategies of regenerative medicine developed for restoring tissue, organ, and appendage structures. Part III reflects

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

Handbook of Stem Cells

Handbook of Stem Cells
  • Author : Anthony Atala,Robert Lanza
  • Publisher : Academic Press
  • Release : 31 December 2012
GET THIS BOOKHandbook of Stem Cells

New discoveries in the field of stem cells increasingly dominate the news and scientific literature revealing an avalanche of new knowledge and research tools that are producing therapies for cancer, heart disease, diabetes, and a wide variety of other diseases that afflict humanity. The Handbook of Stem Cells integrates this exciting area of life science, combining in two volumes the requisites for a general understanding of adult and embryonic stem cells. Organized in two volumes entitled Pluripotent Stem Cells and

Ensuring the Integrity of Electronic Health Records

Ensuring the Integrity of Electronic Health Records
  • Author : Orlando Lopez
  • Publisher : CRC Press
  • Release : 22 December 2020
GET THIS BOOKEnsuring the Integrity of Electronic Health Records

Data integrity is a critical aspect to the design, implementation, and usage of any system which stores, processes, or retrieves data. The overall intent of any data integrity technique is the same: ensure data is recorded exactly as intended and, upon later retrieval, ensure the data is the same as it was when originally recorded. Any alternation to the data is then traced to the person who made the modification. The integrity of data in a patient’s electronic health

How to Validate a Pharmaceutical Process

How to Validate a Pharmaceutical Process
  • Author : Steven Ostrove
  • Publisher : Academic Press
  • Release : 07 June 2016
GET THIS BOOKHow to Validate a Pharmaceutical Process

How to Validate a Pharmaceutical Process provides a “how to approach to developing and implementing a sustainable pharmaceutical process validation program. The latest volume in the Expertise in Pharmaceutical Process Technology Series, this book illustrates the methods and reasoning behind processes and protocols. It also addresses practical problems and offers solutions to qualify and validate a pharmaceutical process. Understanding the “why is critical to a successful and defensible process validation, making this book an essential research companion for all practitioners

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

Principles of Tissue Engineering

Principles of Tissue Engineering
  • Author : Robert Lanza,Robert Langer,Joseph P. Vacanti
  • Publisher : Elsevier
  • Release : 16 May 2000
GET THIS BOOKPrinciples of Tissue Engineering

The opportunity that tissue engineering provides for medicine is extraordinary. In the United States alone, over half-a-trillion dollars are spent each year to care for patients who suffer from tissue loss or dysfunction. Although numerous books and reviews have been written on tissue engineering, none has been as comprehensive in its defining of the field. Principles of Tissue Engineering combines in one volume the prerequisites for a general understanding of tissue growth and development, the tools and theoretical information needed