Commercialization of Investigational Cell Therapy Products

Aimaz Afrough, Helen E. Heslop, La Quisa C. Hill

Research output: Chapter in Book/Report/Conference proceedingChapter

2 Scopus citations


Over the last several decades, cellular therapies have emerged as novel forms of treatment with potential to benefit patients who currently have limited to no treatment options. Cell therapies have been developed for a wide variety of maladies, including heart disease, neurodegenerative diseases, immunodeficiencies, as well as hematologic and solid cancers. However, due to their substantial complexity compared to small molecules or other biologic drugs, developing and commercializing cell therapies remains difficult. Some commonly identified challenges include maintaining stable funding through lengthy developmental timelines, rigorous regulatory hurdles, scalability and manufacturing concerns, distribution, and unclear reimbursement processes. However, limited commercial successes have not dampened enthusiasm or expectations for the field. Here, we describe examples of cellular therapy products that have been successfully commercialized, as well as the components necessary to achieve commercialization.

Original languageEnglish (US)
Title of host publicationCell Therapy
Subtitle of host publicationcGMP Facilities and Manufacturing: Second Edition
PublisherSpringer International Publishing
Number of pages18
ISBN (Electronic)9783030755379
ISBN (Print)9783030755355
StatePublished - Jan 1 2021


  • Commercial cell therapy
  • Commercial investigational products
  • Licensed products

ASJC Scopus subject areas

  • Biochemistry, Genetics and Molecular Biology(all)
  • Medicine(all)


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