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Therapy Manufacturing - Best Practices

Goals

To obtain a list of white papers and articles on the subject of cell therapy manufacturing and clinical trials, as well as on related best practices on a global scale.

Early Findings

Articles and White Papers

Decentralized Manufacturing of Cell and Gene Therapy Products

  • Published in Biotechnology Advances in 2018, this paper was researched and compiled by Richard P. Harrison, Steven Ruck, Qasim A. Rafiq, and Nicholas Medcalf.
  • The article focuses on the subject of decentralized cell therapy manufacturing, which "splits production into various locations or regions and in doing so, imposes organizational changes on the structure of a company".
  • Additionally, the report focuses on best practices and benefits associated with this method, as well as on the drawbacks of it.
  • The article is available in full via ScienceDirect.

Considering Cell Therapy Product “Good Manufacturing Practice” Status

  • This article was published in Frontiers in Medicine in 2018, and was researched and written by Patrick Bedford, Juliana Jy, Lucas Collins, and Steven Keizer.
  • The article begins by addressing the benefits of cell therapy, but focuses primarily on identifying various manufacturing options and their benefits and drawbacks.
  • More specifically, the researchers focused their work on "where to manufacture [cell therapy products], and under what circumstances".
  • The article is available in full via the NCBI.

Manufacturing Cell Therapies: The Paradigm Shift in Health Care of This Century

  • This article was published by the National Academy of Medicine in 2017. The report's authors are Rachel Haddock, Sheng Lin-Gibson, Nadya Lumelsky, Richard McFarland, Krishnendu Roy, Krishanu Saha, Jiwen Zhang, and Claudia Zylberberg.
  • This discussion paper focuses on the applications of cell therapy in modern medicine and science, with a more specific focus on the manufacturing of cell therapy products.
  • "Today, more than 700 companies around the world make up the rapidly growing RM industry, and the global RM market is expected to grow to $67.6 billion by 2020, a large increase from $16.4 billion in 2013."
  • The paper can be read in full on the National Academy of Medicine's website.

Clinical Trials

  • The National Institute of Health has compiled several links and lists of clinical trials focused on cell therapy and stem cell research.
  • Additionally, the American Society of Gene and Cell Therapy also provides a search mechanism to identify and obtain information on existing cell therapy clinical trials.
  • RegMedNet has compiled a list of existing clinical trials focused on all regenerative medicine, including but not limited to cell therapy.

Proposed next steps:

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