Immunoglobulin G as a Therapeutic Drug and its FDA Regulation
The complex protein molecule called immunoglobulin G is the widely studied protein before the invention of automated protein sequencing and recombinant DNA technology, their application as disease therapeutics date back to their detailed knowledge from the structure, immunology, biology, and synthesis of large-quality biopharmaceuticals. Therefore, it was reviewed that immunoglobulin G intended to be used for a therapeutic drug can be developed using hybridoma technology, followed by expansion of the cell lines on industrial scale bioreactor for mass production. Among the subclasses of immunoglobulin G, IgG1 is the best for drug development. Some of the therapeutic potential of immunoglobulin G as a potential drug include its utilization for disease diagnosis, treatment of cancer, viral, bacterial, and fungus infection. Before the manufacturing of mAb by biopharmaceutical companies, there is a need for a license and investigational new drug application with the FDA. Hence, this article reviewed immunoglobulin G, its potential, subclasses, production, and FDA regulation.
yazar | Yusuf Muhammed |
---|---|
Boyutlar ve boyutlar | 15 x 0.3 x 22 cm |
Tarafından yayınlandı | 25 Nisan 2020 |
28 Şubat 2018 30 Eylül 2020 21,6 x 0,6 x 27,9 cm 1 Ocak 2017 Dazzle Book Press U.S. Department of the Interior 1 Haziran 2018 1 Ocak 2018 Kolektif 1 Ocak 2016 15 x 0,6 x 22 cm Flower Love Press Collectif 15 x 0,7 x 22 cm 15 x 0,4 x 22 cm 15 x 0,3 x 22 cm BrownTrout Publisher 15 x 0,5 x 22 cm
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Sürüm ayrıntıları
yazar | Yusuf Muhammed |
---|---|
isbn 10 | 6202530650 |
isbn 13 | 978-6202530651 |
Yayımcı | LAP LAMBERT Academic Publishing |
Boyutlar ve boyutlar | 15 x 0.3 x 22 cm |
Tarafından yayınlandı Immunoglobulin G as a Therapeutic Drug and its FDA Regulation | 25 Nisan 2020 |
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