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Research Outline
Prepared for Ron R. | Delivered October 28, 2019
Therapy Manufacturing - Best Practices
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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.
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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
M
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d
c
a
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f
.
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.
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