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LIFESCIENCELEADER.COM MARCH 2014 29 he tobacco culture runs deep, which may help explain why a company from Canada found its way to North Carolina to build a new facil- ity using tobacco plants as the means of vac- cine production. The new "plant" in Durham, near Research Triangle Park, greatly expands capacity from Medicago's original model facility near its headquarters in Québec City, Québec, Canada. You can certainly read about Medicago's technology and prod- uct pipeline on its website, but you may come away with an appetite for more than the terse and fairly general explanations therein. Even the technical descriptions leave much to the imagi- nation, and you will not get much of a sense of how the company came to be. Though still a virtual unknown after nearly 17 years in business, Medicago is a late-stage clinical developer that has built itself an infrastructure of seemingly commercial dimensions. The Durham plant, at 97,000 square feet, quadruples the original production space in Québec. It includes a huge, automated green- house and equipment to extract product from the tobacco leaves, purify it, and package finished doses — up to 30 million vaccines for seasonal flu or 120,000 for pandemic flu. The company's proprietary manufacturing platform, Proficia, is nothing if not revolutionary, perhaps even worthy of the highly prized appellation "disruptive" — if all your bets are riding on traditional technology for making vaccines and antibodies. The Proficia process inserts genetic material into live tobacco leaves to induce a temporary or "transient" expression of what the com- pany calls "virus-like particles" (VLPs) that mimic viruses but cannot reproduce or cause disease on their own. Although VLPs lack the genetic core of the disease-causing virus, they display the same antigens on a similar structure and thus mobilize the immune system against it. Medicago employs its related "high-throughput" platform, VLPExpress, to rapidly identify the key antigens and design the VLP "presentations." With further refinement, Proficia will also produce antibodies. GROWTH WITH DIRECTION Medicago's current president and CEO, Andy Sheldon, joined the company in mid-2003 with an extensive background in vaccines at Rhône Mérieux, then part of Rhône-Poulenc Rorer, and later at Shire Biologics. Sheldon was attracted both to the opportunity for a new manufacturing technology and to the potential for devel- oping new products on the platform, he says. But the company was still largely research-based — founder Louis-Philippe Vézina, now the CSO — was also its platform inventor. And, like the typi- cal early start-up developing new technology, the company was unsure of its commercial direction. (See "The Micro-Innovators," Life Science Leader, December 2013 and January 2014.) "The whole plant-based manufacturing concept was focused principally on making large quantities of product. Many of the initial companies in the plant world wanted to be contract manu- facturers. But it was always difficult to see how we could possi- In the American South, below the old Mason-Dixon Line, you can walk down some house-lined streets in summer and see tidy plantings of tobacco growing in the front yards. Tobacco barns, built for drying, not storing, are as common down there as hay barns in Wisconsin. Medicago Applies Innovation at the Plant Level W A Y N E K O B E R S T E I N Executive Editor 0 3 1 4 _ F e a t u r e _ M e d i c a g o _ F . i n d d 2 0314_Feature_Medicago_F.indd 2 2 / 2 0 / 2 0 1 4 4 : 2 9 : 1 4 P M 2/20/2014 4:29:14 PM