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ISCT Committee Paper| Volume 24, ISSUE 6, P583-589, June 2022

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Impact considerations of post-production processes on cell and gene drug products

  • Author Footnotes
    ⁎ These authors contributed equally to this work.
    John Fink
    Correspondence
    Correspondence: John Fink, MBA. PerkinElmer 68 Elm St, Hopkinton, MA 01748, USA.
    Footnotes
    ⁎ These authors contributed equally to this work.
    Affiliations
    International Society for Cell & Gene Therapy Process and Product Development Subcommittee, Vancouver, Canada

    PerkinElmer, Hopkinton, Massachusetts, USA
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  • Author Footnotes
    ⁎ These authors contributed equally to this work.
    Michael Scott
    Footnotes
    ⁎ These authors contributed equally to this work.
    Affiliations
    International Society for Cell & Gene Therapy Process and Product Development Subcommittee, Vancouver, Canada

    Novo Nordisk, Fremont, California, USA
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  • Sebastian Rieck
    Affiliations
    International Society for Cell & Gene Therapy Process and Product Development Subcommittee, Vancouver, Canada

    ViaCyte, Inc, San Diego, California, USA
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  • Robert Jones
    Affiliations
    International Society for Cell & Gene Therapy Process and Product Development Subcommittee, Vancouver, Canada

    Cryoport Systems, Irvine, California, USA
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  • Jean-Sebastian Parisse
    Affiliations
    International Society for Cell & Gene Therapy Process and Product Development Subcommittee, Vancouver, Canada

    Aseptic Technologies, Gembloux, Belgium
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  • Heidi Hagen
    Affiliations
    International Society for Cell & Gene Therapy Process and Product Development Subcommittee, Vancouver, Canada

    Vineti, San Francisco, California, USA
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  • Yonatan Lipsitz
    Affiliations
    International Society for Cell & Gene Therapy Process and Product Development Subcommittee, Vancouver, Canada

    Sana Biotechnology, Cambridge, Massachusetts, USA
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  • Steve Oh
    Affiliations
    International Society for Cell & Gene Therapy Process and Product Development Subcommittee, Vancouver, Canada

    Bioprocessing Technology Institute, A*STAR Research Entities, Singapore, Republic of Singapore
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  • Dominic Clarke
    Affiliations
    International Society for Cell & Gene Therapy Process and Product Development Subcommittee, Vancouver, Canada

    Discovery Life Sciences, Huntsville, Alabama, USA
    Search for articles by this author
  • Author Footnotes
    ⁎ These authors contributed equally to this work.

      Abstract

      Cell and gene therapies are demonstrating clinical efficacy, but prohibitive product costs and operational complexity bottlenecks may limit expanded patient access to these innovative and transformative products. An initial survey and subsequent article published through the International Society for Cell & Gene Therapy in 2017 presented a roadmap on how specific steps, from tissue procurement and material acquisition to facility operation and production, contribute to the high cost of cell and gene therapies. Herein the authors expanded the investigation to provide considerations to better understand how post-production procedures can impact a product's accessibility to patients. The administration of a drug product to and follow-up in a patient involve key decisions in several post-production process areas, such as product storage, distribution and handling logistics and compliance, across the value chain through integrated data management solutions. Understanding as well as carefully evaluating these specific components is not widely considered during early process development but is critical in developing a viable product life cycle.
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