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understödjande material (vid tillverkning av en ATMP)

ancillary material [ENGLISH]

Components, reagents and materials involved in the manufacturing process of a cell, gene or tissue-engineered therapeutic product but are not intended to be part of the final product.

understödjande material (vid tillverkning av en ATMP) [SWEDISH]

Komponenter, reagens och material som är involverade i tillverkningsprocessen av en cell-, gen- eller vävnadsteknisk medicinsk produkt som inte är inte avsedda att ingå i slutprodukten.


Resources and references

Definitions have been translated into the Swedish language from the following sources:

  1. 1. American Society of Gene and Cell Therapy Glossary
  2. 2. Clinical Trials Information System
  3. 3. EMA Glossary of Regulatory Terms
  4. 4. EMA Medical Terms simplifier
  5. 5. Glossary of Terms used in EU Clinical Trials Register
  6. 6. Glossary of Terms U.S Food and Drug Administration
  7. 7. National Human Genome Research Institute “Talking Glossary of Genomic and Genetic Terms”
  8. 8. The Glossary for Advanced Therapies Regen. Med. Dec 2020 Vol. 15 No. 12 Suppl. 1
  9. 9. Toolkit For Patient Focused Therapy Development Glossary

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