Items related to Cellular Therapy: Principles, Methods, and Regulations
This manual was designed as a compendium of state-of-the-art practices and methods for cellular therapy to aid in the development and operation of a clinical cellular therapy facility. Designed for those in academia, government and industry, it is also an essential reference for those in regulatory affairs and quality assurance as well as for laboratory technologists, managers, directors, physicians and scientists. Through descriptions of the rationale and methodology for a variety of cell processing and evaluation techniques, it will assist laboratory staff in developing procedures that comply with applicable regulations and standards. In addition to numerous examples and templates for laboratory document preparation, several methods are provided that include a general overview of the critical steps, materials and equipment used in each process. Each section has been compiled and edited by a team of experts in the field, with subchapters contributed by specialists in the specific subject matter. Also included is a fully searchable CD-ROM with appendices on Methods and Forms in Word format so they can be fully customized.
Chapters cover:
Regulatory considerations:
Including FDA perspectives, IND and BLA processes, sample outlines, etc.
Quality assurance:
Including process control, records, audits, safety, equipment, personnel, etc.
Facilities:
Aseptic processing, computer systems, validation and general procedures.
Process development:
Assessment of process elements, assay development and risk assessment.
Product collection:
Marrow, apheresis and cord blood techniques.
Clinical processing:
Including storage, shipping, and disposal; patient preparation, infusion, and reactions; processing methods and product problems; etc.
Product characterization:
Including viability, potency, cytotoxicity, contamination, testing, etc.
CD ROM included
Chapters cover:
Regulatory considerations:
Including FDA perspectives, IND and BLA processes, sample outlines, etc.
Quality assurance:
Including process control, records, audits, safety, equipment, personnel, etc.
Facilities:
Aseptic processing, computer systems, validation and general procedures.
Process development:
Assessment of process elements, assay development and risk assessment.
Product collection:
Marrow, apheresis and cord blood techniques.
Clinical processing:
Including storage, shipping, and disposal; patient preparation, infusion, and reactions; processing methods and product problems; etc.
Product characterization:
Including viability, potency, cytotoxicity, contamination, testing, etc.
CD ROM included
"synopsis" may belong to another edition of this title.
- PublisherAmerican Association of Blood Banks (AABB)
- Publication date2009
- ISBN 10 1563952963
- ISBN 13 9781563952968
- BindingPaperback
- Edition number1
- Number of pages675
- EditorEllen M. Areman, MS, SBB(ASCP), Kathy Loper, MHS, MT(ASCP)
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Cellular Therapy: Principles, Methods, and Regulations [With CDROM]
Published by
American Association of Blood Banks (AABB)
(2009)
ISBN 10: 1563952963
ISBN 13: 9781563952968
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Cellular Therapy: Principles, Methods, and Regulations
Published by
American Association of Blood Banks (AABB)
(2009)
ISBN 10: 1563952963
ISBN 13: 9781563952968
Used
Softcover
Quantity: 1
Seller:
Rating
Book Description Condition: Good. Cover has some rubbing and edgewear. Access codes, CDs, and other accessories may not be included. All items ship Mon-Fri. Seller Inventory # 2Y6JCK007YEQ_ns
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