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Integrated Clinical Scale Manufacturing System for Cellular Products Derived by Magnetic Cell Separation, Centrifugation and Cell Culture
Author(s) -
Apel Michael,
Brüning Mareke,
Granzin Markus,
Essl Mike,
Stuth Juliane,
Blaschke Jessica,
Spiegel Iris,
Müller Sabine,
Kabaha Eiad,
Fahrendorff Elmar,
Miltenyi Stefan,
Schmitz Jürgen,
Balshüsemann Dirk,
Huppert Volker
Publication year - 2013
Publication title -
chemie ingenieur technik
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.365
H-Index - 36
eISSN - 1522-2640
pISSN - 0009-286X
DOI - 10.1002/cite.201200175
Subject(s) - automation , workflow , cell culture , process (computing) , cellular manufacturing , engineering , computer science , process engineering , manufacturing engineering , biology , mechanical engineering , database , genetics , operating system
Abstract Manufacturing of cellular products for therapeutic purposes like stem cell or cancer therapy requires equipment with specific characteristics not always addressed by conventional technologies. A new integrated cell processing device is presented that can handle all current technical requirements for manufacturing cellular products by automation of the complete process in a GMP‐compliant single‐use tubing set. Its capabilities are exemplified in the presented study by successful processing of adult stem cells, natural killer cells, and several cell lines. Multiple cell processing workflows can be automated in a functionally closed environment: from cell separation through cell culture to formulation of the final product.

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