Difference between revisions of "Organogenesis"
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== Apligraph Oral == | == Apligraph Oral == | ||
| − | Organogenesis is presently seeking [[FDA]] approval for | + | Organogenesis is presently seeking [[FDA]] approval for Apligraph Oral, a foreskin-derived product for the "treatment of surgically treated gingival and alveolar mucosal surface defects in adults."<ref>{{REFweb |
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Revision as of 17:45, 18 August 2019
Organogenesis is a corporation based in Canton, MA.[1] They profit from Apligraf, which is a synthetic skin created from harvested foreskins.[2] Novartis Pharmaceuticals Corp. has global marketing rights to Apligraf.
Call for increase of foreskin harvesting
| “ | We Must Be Able To Obtain Adequate Sources Of Supply e manufacture Apligraf for commercial sale, as well as for use in clinical trials, at our Canton, Massachusetts facility. Among the fundamental raw materials needed to manufacture Apligraf are keratinocyte and fibroblast cells. Because these cells are derived from donated infant foreskin, they may contain human-borne pathogens. We perform extensive testing of the cells for pathogens, including the HIV or "AIDS" virus. Our inability to obtain cells of adequate purity, or cells that are pathogen-free, would limit our ability to manufacture sufficient quantities of our products. (Organogensis)[3] |
Apligraph Oral
Organogenesis is presently seeking FDA approval for Apligraph Oral, a foreskin-derived product for the "treatment of surgically treated gingival and alveolar mucosal surface defects in adults."[4]
