Translational Research/Development

PACT will consider supporting activities that will bring proof of concept discoveries into the translational development stage. At the translational research and development stage, the goal is to define the desired characteristics of the cellular product, establish possible methods of cell isolation/expansion, and identify available cGMP reagents. In addition, it is the time where the results of toxicology and ‘proof of concept’ studies, including studies of cell survival kinetics and distribution, are reviewed and the findings extrapolated to human efficacy and safety profiles. Once the proposed cellular product is shown to have the desired activity and safety profile, clinical application may be considered. Tasks in translational development include the following:

  • Product characterization
  • Assay development
  • Standardization of manufacturing procedures
  • Scale-up procedures for cell manufacturing
  • Equipment validation
  • Customization of reagents
  • Product shipping validation
  • Preclinical toxicity and safety studies
  • Product specifications

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