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Cellular Product Toolkit: Guidance and Templates for Evaluating Requests, Fulfilling Requirements, and Delivering Compliant Products

Product Code: 203183DB

When cell collection and manufacturing facilities receive product requests, there are vital questions to ask, issues to consider, and documentation to fulfill to ensure a quality product. The tools in this kit not only guide the navigation of these issues but also provide some practical head starts at various points along the full process chain from request to delivery.

Six modules present essential information in an easily accessible format through point-by-point slides and lists of helpful tips and resources, as well as downloadable templates for ready use. Modules cover considerations by intended use (research, commercial, or nonclinical), donor safety and consent, manufacturing issues, business agreements, and transportation and storage. Supplemental documents include release criteria, forms, SOPs, and more.

Edited by Christina M. Celluzzi, PhD, MS; Marcie Finney, MS, MBA; and Kathy Loper, MHS, MT(ASCP)

AABB, 2020, digital, 212 pages

Member price: $ Free

Nonmember price: $99

Item Details:

View Table of Contents (pdf)

View Preface (pdf)

View Sample Pages (pdf)

List Price: $99.00

Member Price: Free

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