| Viral Test | Each donor unit of plasma is negative for Hepatitis B (HBsAg), Hepatitis C (anti-HCV), Human Immunodeficiency Virus-1 (HIV-1), Human Immunodeficiency Virus-2 (HIV-2), Human Immunodeficiency Virus antibody (HIV-1Ag), and ALT by FDA approved methods. Proper safety precautions for potentially infectious agents must be taken despite these assurances. |
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| Facility | Human AB plasma is collected from healthy donors at FDA licensed facilities located in the US.Processed in a facility that is compliant with FDA guidelines for Class I Medical Devices located in the US |
| Human AB + Serum | Lacks antibodies against the A and B blood typeantigens, preventing reaction with cultured cells(specifically if the cells are destined for therapeutic use). |
Human AB serum is used in tissue engineering, transplantation and cell therapy applications for the expansion of mesenchymal stem cells (MSC) from adipose tissue or mesenchymal stromal cells from human bone marrow; for standardized limbal epithelial stem cell graft generation and transplantation; for ex vivo expansion of NK cells from peripheral blood in Hematopoeitic Stem Cell Expansion Medium; and for upgrading pretransplant human islet culture technology.
Each individual unit is tested and found negative for all required viral markers via FDA-Approved methods (HBsAg, HIV-1, HIV-2, HCV, HIV-1Ag or HIV-1 NAT, ALT and syphilis).
The whole blood is allowed to spontaneously clot before the serum component is separated. These individual units of serum are then pooled, filtered, bottled and cell culture tested for mycoplasma, endotoxin, and sterility.
