Proposal for the International Society for Cell & Gene Therapy position statement on assays for the quality control and potency assessment of adoptive cellular immunotherapies.
expert_opinion · Level V
Where this comes from
- Record sourced from PubMed, PMID 30890307.
- Also identified by DOI 10.1016/j.jcyt.2019.02.001.
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Abstract
Translation of cell and gene therapies from pre-clinical experiments to clinical trials and final drug licensing brings requires the development, verification and even validation of the assays essential for the definition of the drug product. The technical and scientific challenges in doing this are far greater than they seem at first and are compounded by a lack of approved standards for assays used to support (c)GMP manufacture. This paper highlights some of those challenges and proposes solutions based on the experience of our colleagues using similar assay platforms in regulated pathology laboratories.
Medical subject headings
- Cell- and Tissue-Based Therapy
- Drug Approval
- Genetic Therapy
- Immunotherapy, Adoptive
- International Cooperation
- Quality Control