Preparation of autologous dendritic cell vaccine at BSCRO manufacturing facility
30 ml of patient's blood is collected in EDTA vials, along with 2x2x2 mm piece of patient's cancerous tissue preserved by freezing. In BSCRO manufacturing facility leukocytes are separated, counted by FACS sorter, and washed.
After 7 - 11 days of tissue culture dendritic cells can be seen under inverted microscope. Simultaneously cancer antigens are extracted from the patient's cancerous tissue. After the initial 11 days of tissue culture these cancer antigens are used for 'priming' of dendritic cells. 'Primed' dendritic cells are collected on the 18h day, strictly mechanically. The autologous dendritic cell vaccine is placed in the transport medium, without blood serum or antibiotics.
The status of the tissue culture is controlled daily macroscopically and microscopically by an expert. Before release the standard (U.S. and EU) tests for sterility and bacterial endotoxins are carried out.
Application: implantation of the first vial immediately after delivery, implantation of the second vial 4 weeks later.
Autologous dendritic cells are to be kept refrigerated at all times.
Expiration period: 1 month.
BCRO preserves part of the patient's blood and of cancer antigen, so that another autologous dendritic cell vaccine can be prepared 2 months or so later, to be used as above under "Application".
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Preparation of autologous dendritic cell at BSCRO manufacturing facility
30 ml of patient's blood is collected in EDTA vials. In BSCRO manufacturing facility leukocytes are separated, counted by FACS sorter, and washed. After 7 - 11 days of tissue culture dendritic cells can be seen under inverted microscope. Dendritic cells are collected on the 14th day, strictly mechanically, and placed in the transport medium, without blood serum or antibiotics.
The status of the tissue culture is controlled daily macroscopically and microscopically by an expert. Before release the standard (US and EU) tests for sterility and bacterial endotoxins are carried out.
Application: implantation of the first vial immediately after delivery, implantation of the second vial 4 weeks later.
Autologous dendritic cells are to be kept refrigerated at all times.
Expiration period: 1 month.
