VSE knjižnice (vzajemna bibliografsko-kataložna baza podatkov COBIB.SI)
  • Manufacturing, characterization and control of cell-based medicinal products : challenging paradigms toward commercial use
    Salmikangas, Paula ...
    During the past decade, a large number of cell-based medicinal products have been tested in clinical trials for the treatment of various diseases and tissue defects. However, licensed products and ... those approaching marketing authorization are still few. One major area of challenge is the manufacturing and quality development of these complex products, for which significant manipulation of cells might be required. While the paradigms of quality, safety and efficacy must apply also to these innovative products, their demonstration may be demanding. Demonstration of comparability between production processes and batches may be difficult for cell-based medicinal products. Thus, the development should be built around a well-controlled manufacturing process and a qualified product to guarantee reproducible data from nonclinical and clinical studies.
    Vir: Regenerative medicine. - ISSN 1746-0751 (Vol. 10, iss. 1, Jan. 2015, str. 65-78)
    Vrsta gradiva - članek, sestavni del
    Leto - 2015
    Jezik - angleški
    COBISS.SI-ID - 31757785
    DOI

vir: Regenerative medicine. - ISSN 1746-0751 (Vol. 10, iss. 1, Jan. 2015, str. 65-78)
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