Research ArticleTechnology/Application
Risk Assessment Approach to Microbiological Controls of Cell Therapies
Tony Cundell, Scott Drummond, Irving Ford, Dona Reber and Donald Singer; members of the Pharmaceutical Microbiology Expert Discussion Group
PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 229-248; DOI: https://doi.org/10.5731/pdajpst.2019.010546
Tony Cundell
1Microbiological Consulting LLC, Scarsdale, NY;
Scott Drummond
2Johnson & Johnson Companies, NB, NJ;
Irving Ford
3Celgene Corporation, Summit, NJ;
Dona Reber
4Pfizer, Collegeville, PA; and
Donald Singer
5New Beginnings Microbiology, Phoenixville, PA

References
- 1.↵U.S. Congress. 21 U.S. Code Chapter 9--Federal Food, Drug, and Cosmetic Act. https://uscode.house.gov (accessed Dec 10, 2019).
- 2.↵United States Congress. 42 U.S.C. Chapter 6A--Public Health Service. https://uscode.house.gov (accessed Dec 10, 2019).
- 3.↵U.S. Food and Drug Administration. Application of Current Statutory Authorities to Human Somatic Cell Therapy Products and Gene Therapy Products. Fed Regist. 1993, 58 (197), 53248–53251.
- 4.↵CAR T Cells: Engineering Patients' Immune Cells to Treat Their Cancer, 2017. National Cancer Institute Web Site. https://www.cancer.gov/about-cancer/treatment/research/car-t-cells#evolution. (accessed Dec 10, 2019).
- 5.↵European Commission, EudraLex—The Rules Governing Medicinal Products in the European Union, Volume 4: Good Manufacturing Practice: Guidelines on Good Manufacture Practice Specific to Advanced Therapeutic Medicinal Products. European Commission: Brussels, 2018.
- 6.↵European Medicines Agency, Guideline on Human Cell-Based Medicinal Products. EMA: London, 2008.
- 7.↵Friends of Cancer Research and Parker Institute for Cancer Immunotherapy. Designing the Future of Cell Therapies, 2019. Friends of Cancer Research Web site. https://www.focr.org/sites/default/files/pdf/Friends_Cellular_Therapies_White_Paper.pdf (accessed Dec 10, 2019).
- 8.↵
- Mahmood A.,
- Ali S.
- 9.↵Parenteral Drug Association Inc. Technical Report No. 81: Cell-based Therapy Control Strategy; Bethesda, MD, 2019.
- 10.↵U.S. Food and Drug Administration, 21 CFR Part 1271—Human Cells, Tissues, and Cellular and Tissue-Based Products. U.S. Department of Health and Human Services. Government Publishing Office: Washington, D.C., 2019.
- 11.↵
- Agallaco J.
- 12.↵U.S. Pharmacopeial Convention, General Chapter <71> Sterility Tests. https://www.uspnf.com (accessed Dec 10, 2019).
- 13.↵U.S. Food and Drug Administration, Draft Guidance for Industry: Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs). Center for Biologics Evaluation and Research. U.S. Department of Health and Human Services: Rockville, MD, 2018.
- 14.↵U.S. Pharmacopeial Convention, General Chapter <1071> Rapid Sterility Testing of Short Life Products: A Risk Based Approach. https://www.uspnf.com (accessed Dec 10, 2019).
- 15.↵U.S. Pharmacopeial Convention, General Chapter <63> Mycoplasma Tests. https://www.uspnf.com (accessed Dec 10, 2019).
- 16.↵U.S. Pharmacopeial Convention, General Chapter <85> Bacterial Endotoxins Test. https://www.uspnf.com (accessed Dec 10, 2019).
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 2
March/April 2020
Risk Assessment Approach to Microbiological Controls of Cell Therapies
Tony Cundell, Scott Drummond, Irving Ford, Dona Reber, Donald Singer
PDA Journal of Pharmaceutical Science and Technology Mar 2020, 74 (2) 229-248; DOI: 10.5731/pdajpst.2019.010546
Jump to section
- Article
- Abstract
- Introduction
- Overview of Contamination Control
- Microbial Contamination Control Strategy
- Input Materials
- Utilities
- Route of Administration Risk
- Manufacturing Facilities
- Manufacturing Process
- Cell Therapy Product Testing and Release
- Summary
- Conclusions
- Conflict of Interest Declaration
- Disclaimer
- Acknowledgments
- References
- Figures & Data
- References
- Info & Metrics
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Keywords
- Risk-based approach
- Microbial contamination
- Cell therapies
- Donor selection
- Cell collection
- Cell transformation and expansion
- Bacterial endotoxin
- sterility
- Mycoplasma
- Adventitious viruses
- Biological safety cabinets
- Restrictive access barrier systems
- Isolator systems
- In-process sterility testing
- Rapid microbial detection testing