The vision of Life Science Leader is to be an essential business tool for life science executives. Our content is designed to not only inform readers of best practices, but motivate them to implement those best practices in their own businesses.
Issue link: https://lifescienceleadermag.epubxp.com/i/267232
LIFESCIENCELEADER.COM MARCH 2014 30 bly be a contract manufacturer if we had never actually taken our own products to market," Sheldon says. In 2005, Sheldon introduced his board to the idea of the company starting work on a pandemic influenza vaccine and per- manently adopting the product-develop- ment model. Since then, he says, "We have demonstrated we do have a major role to play in the protection of citizens in any country against a pandemic." The next step for Medicago is to demonstrate how its new-product development, based on the same platform, can expand into other areas beyond vaccines, such as those now reserved for antibodies and peptides. Meanwhile, the company con- tinues to improve the quality, capacity, and efficiency of its tobacco-plant vaccine technology, according to Sheldon. He suggests that, although scientific freedom creates opportunities, business depends on inspiring company scientists toward some common goals — in this case, products and platform quality. "The real value of the company lies in what dif- ferentiates it from everyone else — how we strategically position the product, and also our platform's ability to produce con- sistently, cost-effectively, and efficiently." Quality, an oft-heard industrial term, can sound as unfamiliar to company research- ers as does "product focus," and Medicago's manufacturing base offers them another "learning experience," he says. "Getting our scientists to start think- ing about documentation and traceabil- ity, and all the other aspects of produc- tion, has really paid off in spades for us. Today, our people in research are the first ones to think about those things, which is very rewarding." The emphasis on manufacturing also has aided Medicago in its clinical develop- ment programs — led by an H5 pandemic flu vaccine preparing for Phase 3 and a quadrivalent seasonal flu vax entering Phase 2. Unlike many other life sciences start-ups, the company has scaled up its capacity and facilities internally to match demand for its Phase 3 trials, and with obvious order. "From creating VLP technology to work- ing on extremely complex products such as rotavirus, quadrivalent flu, and pan- demic flu vaccines, we have come to see what else this technology can do, not only in the world of vaccines, but eventually in other areas such as biobetters and biosim- ilars," Sheldon says. He believes the com- pany has proved its concept, giving it good reason for confidence in its technology. The VLP approach is further validated, he says, by Medicago's DARPA (U.S. Defense Advanced Research Projects Agency) and Canadian government financial support through a number of grants — and its recent acquisition by Mitsubishi Tanabe. FUNDING BY PURCHASE Yes, I said acquisition. Mitsubishi Tanabe Pharma (MTP) purchased 60 percent of Medicago in September 2013, delisting Medicago's stock and leaving the remain- ing 40 percent of shares in the hands of Philip Morris Investments. So, why am I still writing about Medicago and not Mitsubishi at this point? Well, for The Profi cia Process • Potent immune stimulation • Immunological memory • Lower dosage • No genetic material (noninfectious) Finished Vaccine Vacuum Infi ltration Genetic material introduced into plants through vacuum. Synthesis Gene synthesized from sequence of pandemic virus. Incubation Plants are incubated four to seven days in growth chambers for protein expression and VLP formation. Harvest Plants are harvested to extract VLPs. Purifi cation VLPs are purifi ed to obtain clinical-grade material. 2 3 4 5 6 Profi cia Pluses MEDICAGO APPLIES INNOVATION AT THE PLANT LEVEL By W. Koberstein 1 Medicago's 97,000 square-foot vaccine-production plant in Durham, NC — using tobacco to produce vaccines made of "virus-like particles" grown in tobacco — cost only $40 million to build, versus the hundreds of millions to more than $1 billion required for a typical cell-based plant. That means Profi cia, the company's name for its VLP (virus-like particles) platform, is "less expensive than others and certainly more cost-effective — even for things like a quadrivalent infl uenza vaccine, which is a complex project," according to president and CEO Andy Sheldon. Speed of production is very important with certain vaccines, such as one for pandemic fl u. In 2009, in a test of its H1 fl u candidate, the company "managed to put a protein in a vial with high purity within about 19 days," Sheldon says, "and we did it again with H7 earlier this year, and the H7 project has continued on. "That year, H1 fl u surfaced in Canada in April 2009, but the Canadian vaccine for H1 was not available until mid-October in any meaningful numbers, and we know that we could have certainly beaten that time line by several months." The method Medicago uses to confi gure any vaccine, called VLPExpress, resembles an IT technology, based on Sheldon's description: "We just need the genetic sequence. We can just download the sequence from the Internet and away we go. We go to the lab, we make the DNA fragment, and we put it in a column where we start the phases of manufacturing. The process allows us to program our tobacco leaves. Meanwhile, others have to wait for the viral strain to arrive from the CDC and other authorities." 0 3 1 4 _ F e a t u r e _ M e d i c a g o _ F . i n d d 3 0314_Feature_Medicago_F.indd 3 2 / 2 0 / 2 0 1 4 4 : 2 9 : 3 5 P M 2/20/2014 4:29:35 PM