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About The Publication
The AABB Biotherapies Manual will be a first-of-its-kind reference that provides a structured guide across the full biotherapies lifecycle, from regulation and quality systems to manufacturing, testing, storage, and infusion.
Developed by leading experts from academia, industry, and regulatory agencies, it will deliver practical insights to strengthen programs and ensure safe, effective, high-quality product delivery.
Serving professionals across clinical, academic, and commercial settings, the Manual offers a foundational resource to navigate today’s rapidly expanding biotherapies field.
Sections overview
Introduction
Section 1: Regulatory considerations for manufacturing biotherapy products
Section 2: Cellular Therapy Quality Oversight
Section 3: Cell Processing Operations, Facilities and Equipment
Section 4: Cell Collection
Section 5: Manufacturing Cellular Therapies
Section 6 : Testing and Characterization of Cellular Therapies
Section 7: Laboratory Assays Commonly Use to Evaluate Cellular Therapies
Section 8: Product Storage, Issue, and Infusion
"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."
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