Summary
1) vector’s ability to transfer genetic material into a cell
2)and this function measurement
Refference
Cell-Based Potency Assay Development and Special Considerations for Cellular Therapeutics (Comanche, 2017)
https://www.covance.com/content/dam/covance/assetLibrary/posters/DunnCellTherapy17.pdf
Bioassays for Cell and Gene Therapy Products: A Canadian Regulatory Perspective and Experience (CASSS CMC Bioassays 2018)
https://cdn.ymaws.com/www.casss.org/resource/resmgr/bioassays_speaker_slides/2018_BIOA_Storbeck_Chris_PP_.pdf
ABSORBTION SYSTEMS – Potency Assays for Cell & Gene Therapy Products
https://www.absorption.com/kc/cell-gene-therapy-potency-assay-development/
Potency Tests for Cellular and Gene Therapy Products (FDA)
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/potency-tests-cellular-and-gene-therapy-products
Guidance for Industry Potency Tests for Cellular and Gene Therapy Products (FDA)
https://www.fda.gov/media/79856/download
POTENCY ASSAYS for CELL THERAPY PRODUCTS (pmda, 2016)
https://www.pmda.go.jp/files/000211291.pdf
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