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      Strategy for an abbreviated in-house qualification of a commercially available Rapid Microbiology Method (RMM) for canadian regulatory approval.

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          Abstract

          Cell therapy products (CTP) typically require full sterility, endotoxin and Mycoplasma testing before product release. Often this is not feasible with fresh cells, and sponsors may rely on rapid microbiological methods (RMM). RMM must be qualified in-house using the sponsor's facilities, equipment, consumables, cells and matrices to meet regulatory approval. Herein, we present a cost-effective strategy to conduct an in-house abbreviated qualification of a commercially available RMM kit to meet Health Canada regulatory requirements.

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          Author and article information

          Journal
          Cytotherapy
          Cytotherapy
          Elsevier BV
          1477-2566
          1465-3249
          December 2017
          : 19
          : 12
          Affiliations
          [1 ] The Arthritis Program, Krembil Research Institute, University Health Network, Toronto, Canada; Cell Therapy Program, University Health Network, Toronto, Canada.
          [2 ] The Arthritis Program, Krembil Research Institute, University Health Network, Toronto, Canada; Cell Therapy Program, University Health Network, Toronto, Canada; Institute of Biomaterials and Biomedical Engineering, University of Toronto, Toronto, Canada. Electronic address: sowmya.viswanathan@uhnresearch.ca.
          Article
          S1465-3249(17)30703-X
          10.1016/j.jcyt.2017.09.004
          29066052
          b7c8cba6-ae52-4201-b669-2bd23c0aeade
          History

          rapid microbiological method (RMM),qualification,pharmacopeia,nucleic acid amplification technique (NAT),mycoplasmas,cell therapy products (CTPs)

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