Microbial Safety of Cellular Therapeutics - Lessons from over ten years’ experience in microbial safety of platelet concentrates
Author(s): ,
Erica Wood
Affiliations:
Transfusion Research Unit, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
Birgit Gathof
Affiliations:
Transfusion Medicine, University Hospital Cologne
ISBT Education. Stoermer M. Jun 3, 2018; 218841
Topic: Safety and adverse events
Dr. Melanie Stoermer
Dr. Melanie Stoermer
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After viewing this presentation the participant will be able to:

-Understand the challenges of Microbiological Control of Cellular Products
-See the need for revisions of existing regulations and expectations
-Understand the advantages of alternative methods for bacterial detection
Bacterial safety of cellular preparations including blood products and stem cell preparations still present challenges for physicians, manufacturers and regulators. Although there have been many new approaches to enhance the microbial safety of cellular products during the last decade, established methods for microbiological control still need to be fully adapted to the special circumstances of cellular preparations. The experience from transfusion medicine regarding microbial safety of blood components has already demonstrated the variety of problems and risk factors for the development of new strategies for microbial safety.
Special attention has been given to strategies and recommendations for the prevention and detection of bacterial contamination of platelet concentrates. But so far none of the targeted strategies for rapid detection or pathogen reduction have become routinely implemented worldwide, in part at least because development and requirements of new technologies and their implementation into the routine laboratory setting is a whole different problem. As a result, the classical microbiological control methods still represent the gold standard. But factors including the short shelf-life and nontraditional lot sizes for cellular and gene-therapy products are driving the need for rapid microbiological methods.
Significant changes in regulatory requirements have been made recently by revising chapters of the European Pharmacopeia or by the FDA making changes to the requirements to address the needs of next-generation therapies. The other side of the coin is that standardized conditions will require extensive validation based on the conception of the corresponding authorities.
In conclusion, lessons from the microbial safety of platelet concentrates enable us to understand that the detection or reduction of bacteria represents a more difficult challenge in comparison to viruses and that cellular products with different formulations and shelf-lives may present different challenges. Recent regulatory changes demonstrate that we are getting closer to the goal of a shift from the traditional view of sterility evaluation (identify and inactivate anything and everything) to a new thinking about microbiological control.
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Störmer M, Vollmer T. Diagnostic methods for platelet bacteria screening: current status and developments. Transfus Med Hemother. 2014; 41(1):19-27.

Jacobs MR, Good CE, Fox RM, Roman KP, Lazarus HM. Microbial contamination of hematopoietic progenitor and other regenerative cells used in transplantation and regenerative medicine. Transfusion. 2013; 53(11):2690-6.

Ramirez-Arcos S, Kou Y, Yang L, Perkins H, Taha M, Halpenny M, Elmoazzen H. Validation of sterility testing of cord blood: challenges and results. Transfusion. 2015; 55(8):1985-92.

Schurig U, Karo JO, Sicher U, Spindler-Raffel E, Häckel L, Spreitzer I, Bekeredjian-ding I. Aktuelles Konzept zur mikrobiologischen Sicherheit von zellbasierten Arzneimitteln. Bundesgesundheitsbl 2015; 58:1225-32.

Montag T, Nicol SB, Schurig U, et al.: Microbial safety of cell based medicinal products – what can we learn from cellular blood components. Clin Chem Lab Med 2008; 46:963-965
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