Standards for Cellular Therapy Services

Standards for Cellular Therapy Services
Author: Aabb
Publisher: American Association of Blood Banks (AABB)
Total Pages: 0
Release: 2013
Genre: Blood banks
ISBN: 9781563958656

Preceded by: Standards for cellular therapy product services. 5th ed. c2011.

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.

Hematopoietic Stem Cell Transplantation and Cellular Therapies for Autoimmune Diseases

Hematopoietic Stem Cell Transplantation and Cellular Therapies for Autoimmune Diseases
Author: Richard K. Burt
Publisher: CRC Press
Total Pages: 687
Release: 2021-11-17
Genre: Medical
ISBN: 1351364766

This book summarizes the global progress in medical and scientific research toward converting traditionally chronic autoimmune diseases into a drug-free reversible illness using hematopoietic stem cell transplantation (HSCT) and other cellular therapies such as T regulatory cells (Treg), mesenchymal stromal/stem cells, and chimeric antigen receptor T (CAR T) cells in order to reintroduce sustained immune tolerance. This title provides information on different types of stem cells and immune cells; post-transplant immune regeneration; cellular regulatory requirements; ethical and economic considerations; and the advantages and disadvantages of HSCT in the treatment of a variety of autoimmune diseases versus current conventional treatments. Arranged by disease, the text provides a comprehensive guide to HSCT for all types of autoimmune/immune disorders including monogenetic autoimmune diseases; autoimmune aplastic anemia; neurologic immune diseases including multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, neuromyelitis optica, and stiff person syndrome; rheumatologic diseases such as systemic sclerosis and systemic lupus erythematosus; dermatologic diseases such as pemphigus; gastrointestinal disorders such as Crohn’s disease and celiac disease; and immune-mediated endocrinologic disease type I diabetes mellitus. Guidance is provided on the transplantation technique, cell collection and processing, conditioning regimens, infections, and early and late complications. Key Features Outlines therapies and techniques for HSCT for autoimmune diseases Discusses the advantages of HSCT over conventional therapies Reviews the entire process of stem cell therapy from harvest and ethics to indications, efficacy, and regulatory oversight