PermaLife Cell Culture Bag

This is a notice of intent, not a request for a quotation.  A solicitaiton document will not be issued and quotations will not be requested.The Government intends to award a fixed price purchase order to Origen Biomedical, Inc., Austin, Texas  78744.The Department of Transfusion Medicine (DTM) at the National Institutes of Health (NIH) Clinical Center (CC), Bethesda, MD  has a requirement to procure the supplies listed below:1.  PL30-2G    Permalife Cell Culture Bag 30ml                  400 each2.  PL07-2G    Permalife Cell Culture Bag 7ml                    20 each3.  PL120-2G  Permalife Cell Culture Bag 120ml                130 each4.  PC2-B       Protective Cap for female luer                     100 each5.  PL240-2G  Permalife Cell Culture Bag 240                    50 each6.  PL325-2G  Permalife Cell Culture Bag 325ml                150 each7.  PL70-2G    Permalife Cell Culture Bag 70ml                  60 eachThe Center for Cellular Engineering (CCE), Department of Transfusion

Medicine, NIH Clinical Center (CC) is an AABB accredited cellular therapy laboratory whose central mission is to provide services to the NIH Institutes to support their intramural clinical trials.  These services include (1)  performing research aimed at development, evaluation and validation of new manufacturing processes for cellular therapies (2) manufacture of cellular therapy products for approved clinical trials.  The majority of these trials are early phase (l/ll) trials not intended to result in the development of a commercial product.  CCE produces clinical therapies from cells collectd from NIH CC patients and healthy donors.  The product manufactured in this project by the laboratory is retinal pigment epithelium (RPE) generated from patient's blood cells.  this product (RPE) will be used to treat age-related manufacturing process of this product.  RPE will be manufactured using US Food and Drug Administration (FDA) guidelines for good manufacturing practices (GMP).  It will require review and approval for use as an investigational new drug (IND) by the FDA.