Bethesda, MD - The Association for the Advancement of Blood & Biotherapies (AABB) AABB is pleased to announce the publication of The AABB Biotherapies Manual, a first-of-its-kind reference covering practices for developing and producing cellular and biotherapy products.
This publication was designed as a compendium of state-of-the-art practices for developing and producing cellular and biotherapy products. Written and edited by experts from academia, industry and regulatory agencies, the AABB Biotherapies Manual provides information on requirements and common practices in cell processing and evaluation.
"We’ve gathered an outstanding group of leaders in the field to create what will be the go-to text on biotherapies — covering everything from regulations and quality to product development and ultimately patient administration" said David McKenna, MD, scientific & medical director at University of Minnesota and AABB Biotherapies Manual editor.
The AABB Biotherapies Manual is intended to support laboratory staff in developing procedures that comply with applicable regulations and standards. It provides useful information for facilities that are entering, and thriving in, this fast-paced field, whether for research, translational or clinical operations. Applicable to 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.
The manual's 35 chapters and appendices cover the critical steps, materials and equipment used in various processes. Sections address regulatory considerations, quality oversight, processing operations, facilities and equipment, cell collection, product development and manufacturing, testing and characterization of cells, laboratory assays, and product storage, issue and infusion. The publication also includes examples and templates for laboratory document preparation and facility activities, as well as a crosswalk between chapter content and the Certified Advanced Biotherapies Professional (CABP) domains.
For more information about the book or to purchase, visit www.aabb.org/aabb-store.
About AABB AABB (Association for the Advancement of
Blood & Biotherapies) is an international, not-for-profit organization
representing individuals and institutions involved in the fields of transfusion
medicine and biotherapies. The Association works collaboratively to advance the
field by developing and delivering standards, accreditation, and education
programs. AABB is dedicated to its mission of improving lives by making
transfusion medicine and biotherapies safe, available, and effective worldwide.
For more information, visit www.aabb.org. 4550 Montgomery Avenue Suite 700, North Tower
Bethesda, MD 20814
301.907.6977 www.aabb.org
