Microbial safety of cellular therapeutics-lessons from over ten years’ experience in microbial safety of platelet concentrates

Author:

Störmer Melanie1,Wood Erica M.2,Gathof Birgit1

Affiliation:

1. Transfusion Medicine; University Hospital Cologne; Cologne Germany

2. Transfusion Research Unit; Department of Epidemiology and Preventive Medicine; Monash University; Melbourne VIC Australia

Publisher

Wiley

Subject

Computer Networks and Communications,Hardware and Architecture,Software

Reference67 articles.

1. A brief overview of cell therapy and its product;Kim;J Korean Assoc Oral Maxillofac Surg,2013

2. FDA Guidance for Industry Validation of growth-based rapid microbiological methods for sterility testing of cellular and gene therapy products http://rapidmicromethods.com/references/Validation%20of%20Growth-Based%20Rapid%20Microbiological%20Methods%20for%20Sterility%20Testing%202011.pdf

3. Towards a rapid sterility test?;Sandle;J Microb Biochem Technol,2015

4. Microbial safety of cell based medicinal products - what can we learn from cellular blood components;Montag;Clin Chem Lab Med,2008

5. Problems in microbial safety of Advanced Therapy Medicinal Products-squaring the circle (German);Montag;Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz,2010

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