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Albagen™

The Albagen™ platform is the result of the Company’s research in support of the CADEX program.

This program has led to the production of recombinant human serum albumin and includes a variety of therapeutic and non-therapeutic applications, including (1) a hypoallergenic, highly characterized, recombinant HSA (rHSA) for use as a research reagent and an excipient in therapeutic products destined for humans, and (2) albumin fragments and polymers with tunable vascular residence time, which influence blood half-life when fused to biologics used as therapeutics.

Applications for rHSA include ADME research, cell culture, protein therapeutics, drug delivery, drug and vaccine formulation, cryopreservation of cells, and IVF (in vitro fertilization). From this broad range of applications, to date the Company has focused on cell culture and other non-therapeutic applications.

The Company’s rHSA has all of the biological properties of human serum albumin with the following important characteristics and commercial advantages: (1) free from risk of contamination with human and animal viruses or prions, (2) reduced affinity for nickel and copper, (3) produced in Pichia pastoris, an FDA-approved and proven expression system, and (4) derived from the prototypical human serum albumin sequence with a deletion of Asp at the N-terminus, which reduces the risk of at least one source of antigenic response (metal chelation at the N-terminus).