Rubrik: GMP / GLP / GCP
(Treffer aus pharmind, Nr. 04, Seite 508 (2019))
van den Bos C | Jossen V | Eibl D | Eibl R
Advanced Therapy Medicinal Products (ATMPs) & GMP – 10 years after / van den Bos et al. • ATMP & GMP · van den Bos C, Jossen V, Eibl D, Eibl R ·
1Mares Ltd., Greven und Institute of Chemistry and Biotechnology, Zurich University of Applied Sciences, Wädenswil, Switzerland
Previously, two types of medical products were known in the EU regulatory framework: first, medicinal products, i.e. drugs, and, second, medical devices ranging in complexity from simple tubing to complex instruments such as pacemakers. Scientific discoveries led to the development of additional entities as active pharmaceutical ingredients – proteins such as antibodies and, further, living cells and tissues. Beyond cells and cell aggregates/tissues considered for replacing diseased tissue, genetic engineering provided tools to address e.g. genetic diseases so that constructs containing recombinant nucleic acids also became drug candidates. Products generated by such technologies fitted into neither of the existing classes ...