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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.

Author: Chirino, Arthur J., Mire-Sluis, Anthony
Publisher: Nature Publishing Co.
Publication Name: Nature Biotechnology
Subject: Business
ISSN: 1087-0156
Year: 2004
Product information, Biological Products, Research, Usage, Testing, Biological assay, Bioassay

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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.

Author: Ying, C. Song et al
Publisher: Nature Publishing Co.
Publication Name: Nature Biotechnology
Subject: Business
ISSN: 1087-0156
Year: 2000
Biosynthetic Vascular Implants, Cardiovascular implants

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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.

Author: Bulte, Jeff W.M. et al.
Publisher: Nature Publishing Co.
Publication Name: Nature Biotechnology
Subject: Business
ISSN: 1087-0156
Year: 2001
Electronic components, not elsewhere classified, Other Electronic Component Manufacturing, Biological Processors, Magnetic Sensors

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Subjects list: United States
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