Characterizing biological products and assessing comparability following manufacturing changes
Article Abstract:
The manufacturing changes of a biological product are necessary for the assessment of comparability in order to ensure that these changes in the production methods have not affected the safety, identity, purity or efficacy of the product. Thus, bioanalytical, functional and immunogenicity assays are used in assessing protein products from generics manufacturers.
Publication Name: Nature Biotechnology
Subject: Business
ISSN: 1087-0156
Year: 2004
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Vitreous cryopreservation maintains the function of vascular grafts
Article Abstract:
Vitrification, which is the solidification in an amorphous glassy state that obviates ice nucleation and growth, is the process that prevents ice formation during cooling. Vitrification results in much better preservation of vascular tissue.
Publication Name: Nature Biotechnology
Subject: Business
ISSN: 1087-0156
Year: 2000
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Magnetodendrimers allow endosomal magnetic labeling and in vivo tracking of stem cells
Article Abstract:
Researchers in the U.S. developed magnetodendrimers (magnetic tags) that can be used to tag mammalian cells including stem cells for study.
Publication Name: Nature Biotechnology
Subject: Business
ISSN: 1087-0156
Year: 2001
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