title: 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.
authors.affiliation: STEMCELL Technologies Inc, Vancouver, BC, Canada. Electronic address: jennifer.solomon@stemcell.com.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Solomon
authors.affiliation: STEMCELL Technologies Inc, Vancouver, BC, Canada.
authors.forename: Lynn
authors.initials: L
authors.lastname: Csontos
authors.affiliation: Charter Medical Ltd, Winston-Salem, NC, USA.
authors.forename: Dominic
authors.initials: D
authors.lastname: Clarke
authors.affiliation: Juno Therapeutics, Seattle, WA, USA.
authors.forename: Mark
authors.initials: M
authors.lastname: Bonyhadi
authors.affiliation: Akron Biotech LLC, Boca Raton, FL, USA.
authors.forename: Claudia
authors.initials: C
authors.lastname: Zylberberg
authors.affiliation: Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas, MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: Ian
authors.initials: I
authors.lastname: McNiece
authors.affiliation: Robertson Clinical and Translational Cell Therapy Program, Department of Pediatrics, Duke University School of Medicine, Durham, NC, USA.
authors.forename: Joanne
authors.initials: J
authors.lastname: Kurtzberg
authors.affiliation: QIMR Berghofer Institute of Medical Research, Brisbane, Queensland, Australia.
authors.forename: Rosemarie
authors.initials: R
authors.lastname: Bell
authors.affiliation: Rubius Therapeutics Inc, Cambridge, MA, USA.
authors.forename: Robert
authors.initials: R
authors.lastname: Deans
mesh_terms: D064987:Cell- and Tissue-Based Therapy / Q000379:methods*; D006801:Humans; D038622:Internationality; D012926:Social Control, Formal; D009626:Terminology as Topic
keywords: ancillary materials; cGMP; cellular therapy; raw materials; regulation; stem cell research; translational medical research