Biolex, Inc.: Pharmaceutical Production in Plants

Abstract

The space of transgenic or alternative expression systems has become crowded in the last five to ten years. “Though there has been a lot of talk about transgenic animals and plants, most of those platforms have not gone forward because of timing and speed,” says Spencer. For many transgenic plants—as well as transgenic animals—you have to have several generations before you have a commercial-production seed bank or flock. “Ours is the only stable transgenic system that establishes a high-expressing master plant line in six months, which speeds the time to make sufficient product for scale-up and animal and human trials,” he says.The LEX System is contained in facilities designed to ensure safety and lot-to-lot reproducibility. “We are not out in a field, where there is a public perception that spreading of transgenic pollen may contaminate food crops with drugs,” says Spencer. Each bioprocessing suite is fully enclosed, contained to approximately 200 square feet. And the plant-based manufacturing system largely avoids the risk of contamination by human pathogens, a limiting factor of human protein production in mammalian cells and transgenic animals.Biolex has a strong intellectual-property position around the transformation of duckweed and the manufacturing of therapeutic proteins in all plants of the family Lemnaceae. “We are the only company that controls transformation of the host and all its subspecies to produce therapeutic proteins,” says Spencer. “By comparison, nobody controls transgenic sheep or corn.”