Integrated Clinical Scale Manufacturing System for Cellular Products Derived by Magnetic Cell Separation, Centrifugation and Cell Culture

• Published in: Chemie ingenieur technik Vol. 85; no. 1-2; pp. 103 - 110
• Main Authors: 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
• Format: Journal Article
• Language: English
• Published: Weinheim WILEY-VCH Verlag 01-02-2013; WILEY‐VCH Verlag
• Subjects: Automated cell culture; Automation; Cell therapy; Centrifugation chamber; Clinical cell processing; Density gradient separation; Magnetic cell separation; Tubing set
• ISSN: 0009-286X; 1522-2640
• DOI: 10.1002/cite.201200175

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.
A new platform technology for cell processing is introduced that facilitates fully automated manufacturing of cellular products for clinical applications in a single‐use tubing set. This functionally closed disposable integrates multiple workflows like cell washing, labeling, separation and cultivation. Thereby, it may allow advancing innovative research into next generation cellular therapies for routine use.