Exbumin Guidelines For Use

Exbumin® stabilizes virus and other biologics such as vaccines, gene therapies and whole-cell therapies in final formulation and during manufacturing. It is a lyophilized animal component free (ACF) recombinant human serum albumin (rHSA). Exbumin® is used as a media component to improve viral titer during inoculation and as an excipient added to final formulations to enhance viral stability prior to injection.

Exbumin® is regulatory friendly and has been shown to be safe in more than 250,000 human injections. Both the EMA and FDA have approved the use of Exbumin® in final formulations of injectable biologics and have approved biologics that incorporate Exbumin® in the manufacturing process. Due to its recombinant DNA manufacturing method, Exbumin® does not have donor-to-donor variability or risk of human or bovine adventitious agent contamination compared to blood-derived products. Exbumin® is cGMP and manufactured in an ISO9001:2015 certified facility. Exbumin® is manufactured in the USA and is available for distribution worldwide.