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
Publisher: Springer Nature
Total Pages: 181
Release: 2021-02-19
Genre: Medical
ISBN: 3030644928

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 program. Written by experts in the field, Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy: A Practical Guide is a valuable resource for physicians, healthcare professionals, and laboratory staff involved in the creation and maintenance of a state-of-the-art HSCT and cellular therapy program.

The EBMT/EHA CAR-T Cell Handbook

The EBMT/EHA CAR-T Cell Handbook
Author: Nicolaus Kröger
Publisher: Springer Nature
Total Pages: 221
Release: 2022-02-07
Genre: Medical
ISBN: 3030943534

This first open access European CAR-T Handbook, co-promoted by the European Society for Blood and Marrow Transplantation (EBMT) and the European Hematology Association (EHA), covers several aspects of CAR-T cell treatments, including the underlying biology, indications, management of side-effects, access and manufacturing issues. This book, written by leading experts in the field to enhance readers’ knowledge and practice skills, provides an unparalleled overview of the CAR-T cell technology and its application in clinical care, to enhance readers’ knowledge and practice skills.

Standards for Cellular Therapy Product Services

Standards for Cellular Therapy Product Services
Author: S. Karger AG
Publisher: Amer Assn of Blood Banks
Total Pages: 118
Release: 2004-01
Genre: Medical
ISBN: 9783805578882

In 2002, the AABB Board of Directors created a standards program unit specifically charged with drafting a set of Standards to encompass all areas of cellular therapy, including HPC, cord blood, and somatic cell activities. The intent of creating a single set of Standards addressing these three types of cellular therapy products is to minimize the need for redundant assessments of facilities that are involved in the procurement, processing, storage, or issue of more than one type of cellular therapy product. This book is formatted according to the Core 10 quality template. Both the Standards for Hematopoietic Progenitor Cell and Cellular Product Services, 3rd edition, and the Standards for Cord Blood Services, 1st edition utilized a 20 chapter format, known as the Core 20 template. The Core 10 template contains the same language as the Core 20 template, although it relies on a 10-chapter structure that mirrors the Quality System Essentials (QSE). In addition to this change in the formatting of Standards, there are several new technical requirements in the Standards for Cellular Therapy Product Services, 1st edition.

Cell Therapy

Cell Therapy
Author: Adrian P. Gee
Publisher: Springer Nature
Total Pages: 681
Release: 2021-11-10
Genre: Science
ISBN: 3030755371

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 blood banking, cell processing, vector production and qualification of a new facility. Several chapters cover facility infrastructure including cleaning and maintenance, vendor qualification, writing a Standard Operating Procedure, staff training, and process validation. The detailed and invaluable product information covers topics like labelling, release and administration, transportation and shipment, et al. Further chapters cover relevant topics like writing and maintaining investigational new drug applications, support opportunities in North America and the European Union, commercial cell processing and quality testing services, and financial considerations for academic GMP facilities. A chapter on future directions rounds out Cell Therapy: cGMP Facilities and Manufacturing making it essential reading for any cell therapy professional involved in the development, use, or management of this type of facility.

Guide to Cell Therapy GxP

Guide to Cell Therapy GxP
Author: Joaquim Vives
Publisher: Academic Press
Total Pages: 279
Release: 2015-07-24
Genre: Technology & Engineering
ISBN: 0128031166

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