Current perspectives on the use of ancillary materials for the manufacture of cellular therapies.
Abstract
Continued growth in the cell therapy industry and commercialization of cell therapies
that successfully advance through clinical trials has led to increased awareness around
the need for specialized and complex materials utilized in their manufacture. Ancillary
materials (AMs) are components or reagents used during the manufacture of cell therapy
products but are not intended to be part of the final products. Commonly, there are
limitations in the availability of clinical-grade reagents used as AMs. Furthermore,
AMs may affect the efficacy of the cell product and subsequent safety of the cell
therapy for the patient. As such, AMs must be carefully selected and appropriately
qualified during the cell therapy development process. However, the ongoing evolution
of cell therapy research, limited number of clinical trials and registered cell therapy
products results in the current absence of specific regulations governing the composition,
compliance, and qualification of AMs often leads to confusion by suppliers and users
in this field. Here we provide an overview and interpretation of the existing global
framework surrounding AM use and investigate some common misunderstandings within
the industry, with the aim of facilitating the appropriate selection and qualification
of AMs. The key message we wish to emphasize is that in order to most effectively
mitigate risk around cell therapy development and patient safety, users must work
with their suppliers and regulators to qualify each AM to assess source, purity, identity,
safety, and suitability in a given application.
Type
Journal articleSubject
HumansInternationality
Social Control, Formal
Terminology as Topic
Cell- and Tissue-Based Therapy
Permalink
https://hdl.handle.net/10161/25710Published Version (Please cite this version)
10.1016/j.jcyt.2015.09.010Publication Info
Solomon, Jennifer; Csontos, Lynn; Clarke, Dominic; Bonyhadi, Mark; Zylberberg, Claudia;
McNiece, Ian; ... Deans, Robert (2016). Current perspectives on the use of ancillary materials for the manufacture of cellular
therapies. Cytotherapy, 18(1). pp. 1-12. 10.1016/j.jcyt.2015.09.010. Retrieved from https://hdl.handle.net/10161/25710.This is constructed from limited available data and may be imprecise. To cite this
article, please review & use the official citation provided by the journal.
Collections
More Info
Show full item recordScholars@Duke
Joanne Kurtzberg
Jerome S. Harris Distinguished Professor of Pediatrics
Dr. Kurtzberg is an internationally renowned expert in pediatric hematology/oncology,
pediatric blood and marrow transplantation, umbilical cord blood banking and transplantation,
and novel applications of cord blood and birthing tissues in the emerging fields of
cellular therapies and regenerative medicine. Dr. Kurtzberg serves as the Director
of the Marcus Center for Cellular Cures (MC3), Director of the Pediatric Transplant
and Cellular Therapy Program, Director of the Carolina

Articles written by Duke faculty are made available through the campus open access policy. For more information see: Duke Open Access Policy
Rights for Collection: Scholarly Articles
Works are deposited here by their authors, and represent their research and opinions, not that of Duke University. Some materials and descriptions may include offensive content. More info