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Towards Automated Manufacturing for Cell Therapies

  • CART and Immunotherapy (M Ruella and P Hanley, Section Editors)
  • Published:
Current Hematologic Malignancy Reports Aims and scope Submit manuscript

Abstract

Purpose of Review

Many cell therapy products are beginning to reach the commercial finish line and a rapidly escalating pipeline of products are in clinical development. The need to develop manufacturing capability that will support a successful commercial business model has become a top priority as many cell therapy developers look to secure long-term visions to enable both funding and treatment success.

Recent Findings

Manufacturing automation is both highly compelling and very challenging at the same time as a key tactic to address quality, cost of goods, scale, and sustainability that are fundamental drivers for commercially viable manufacturing.

Summary

This paper presents an overview and strategic drivers for application of automation to cell therapy manufacturing. It also explores unique automation considerations for patient-specific cell therapy (PSCT) where each full-scale lot is for one patient vs off-the-shelf cell therapy (OTSCT) where a full-scale lot will treat many patients, and finally some practical considerations for implementing automation.

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Authors and Affiliations

  1. Hitachi Chemical Advanced Therapeutics Solutions LLC, Allendale, NJ, USA

    David Smith, Thomas R. J. Heathman, Alex Klarer, Courtney LeBlon & Brian Hampson

  2. Hitachi Chemical Company, Yokohama, Japan

    Yasuhiko Tada

Authors
  1. David Smith
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  2. Thomas R. J. Heathman
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  3. Alex Klarer
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  4. Courtney LeBlon
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  5. Yasuhiko Tada
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  6. Brian Hampson
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Corresponding author

Correspondence to David Smith.

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Conflict of Interest

All authors are employees of Hitachi Chemical Advanced Therapeutic Solutions.

David Smith, Thomas R.J. Heathman, Alex Klarer, Courtney LeBlon, Yasuhiko Tada, and Brian Hampson declare that they have no conflict of interest.

Human and Animal Rights and Informed Consent

This article does not contain any studies with human or animal subjects performed by any of the authors.

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This article is part of the Topical Collection on CART and Immunotherapy

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Smith, D., Heathman, T.R.J., Klarer, A. et al. Towards Automated Manufacturing for Cell Therapies. Curr Hematol Malig Rep 14, 278–285 (2019). https://doi.org/10.1007/s11899-019-00522-y

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  • DOI: https://doi.org/10.1007/s11899-019-00522-y

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