Cellular immunotherapies are expected to greatly impact the future therapeutic landscape. Like other innovative and transformative fields, the industry is currently refining to keep pace with available technology. As a result, developers are employing more controls to minimize variability, and suppliers are addressing industry needs by addressing supply issues and characterizing material attributes with the careful awareness to the impact of the cost of the therapies. Process and analytical technologies are continuing to develop along with the components that are needed for them.
Future efforts will focus in closing the gap in standardization of processes and materials. Creation of standards can mitigate risks associated with the variability intrinsic to cell therapy products. Increased characterization of processes, methods, products, and materials will also address variability within the cell therapy field.
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Advanced Regenerative Manufacturing Institute
American Society for Testing and Materials
corrective action/preventative action
cluster of differentiation
Code of Federal Regulations
critical material attribute
critical process parameter
critical quality attribute
good manufacturing practice
International Organization for Standardization
National Institute for Innovation in Manufacturing Biopharmaceuticals
National Institute of Standards and Technology
Parenteral Drug Association
Standards Coordinating Body
Standards Development Organization
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Thanks to Chuck Felice, Hari Kamaraju, Don Powers, Kathleen Vermeersch, Cristy Dougherty, Ravi Bhatia, and Jean Stanton for their input and helpful discussions.
Conflict of Interest
Carl Burke is employed at Century Therapeutics, a cell therapy company. Claudia Zylberberg is Co-founder and CEO of Akron Biotech, a company that provides ancillary materials for cell and biological products, and sits on the Standards Coordinating Body. Both authors have no conflicts of interest.
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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Burke, C.J., Zylberberg, C. Sources of Variability in Manufacturing of Cell Therapeutics. Regen. Eng. Transl. Med. 5, 332–340 (2019). https://doi.org/10.1007/s40883-019-00130-5
- Cell therapy
- Ancillary material