Tissue Culture: Human Products

The venous blood from which the plasma/serum is manufactured has been tested for HBsAg and HCV NAT and found to be non-reactive by a currently approved FDA test. The blood has also been tested for HIV-1 NAT and antibodies and found to be non-reactive. In accordance with Current Good Manufacturing and Laboratory Practices (cGMP), any protein of human blood origin should be handled as if it is capable of transmitting infections. Human Sera are supplied as “converted” which are derived from plasma, or “off the clot” which are from naturally clotted whole blood collected in containers without anticoagulant. These products are intended for in-vitro use only. All are sterile filtered and suitable for cell culture. Not for human use.