Difference between revisions of "Organogenesis"
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{{Citation | {{Citation | ||
|Title=We Must Be Able To Obtain Adequate Sources Of Supply | |Title=We Must Be Able To Obtain Adequate Sources Of Supply | ||
| − | |Text=We 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. | + | |Text=We 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. |
|Author= | |Author= | ||
|Source=Organogensis | |Source=Organogensis | ||
Revision as of 11:41, 1 December 2021
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 We 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]
References
- ↑
(2010). Headquarters
, Organogenesis. Retrieved 6 March 2011.
Quote:The corporate headquarters and manufacturing facility are located in Canton, Massachusetts.
- ↑ (2011).
Apligraf: How Is It Made?
, Organogenesis. Retrieved 6 March 2011.
Quote:Human keratinocytes and fibroblasts are derived from neonatal foreskins.
- ↑ Organogensis, 2001 Annual Report (Delaware: Organogenesis, 2001), p.8.
- ↑ (17 November 2011).
November 17, 2011: Cellular, Tissue and Gene Therapies Advisory Committee Meeting: Transcript
. Retrieved 20 December 2011.
