When it comes to manufacturing, Big Pharma prefers traditional plants to living plants. While drugs manufactured from plants like tobacco have been in the news because several makers of Ebola drug candidates are using the process, the method has not been embraced by any of the major players.
Israeli-based Protalix Biotherapeutics ($PLX) and partner Pfizer ($PFE) got FDA approval in 2012 for Elelyso, a drug for Gaucher disease that Protalix produces from genetically engineered carrot cells. But the cells are replicated in a traditional disposable system, not in the plants themselves, as is being done by some other companies, like Map Pharmaceutical ($MAPP), the U.S. company which is making an Ebola treatment.
Protalix CEO David Aviezer thinks that seeing a clean room for production makes the FDA more comfortable with a new approach that is cheaper but different. "We actually use cell culture--carrot cells or tobacco--in a way that is similar to what is done in growing mammalian cells for the biotech industry,"Aviezer said.
In fact, the FDA has expressed reservations over plantibodies, suggesting that manufacturers will need to show that the source plant can turn out a consistent product.
Map's drug, Reuters reports, is a "cocktail" of antibodies produced in tobacco plants by a unit of cigarette maker Reynolds American called Kentucky BioProcessing. The San Diego drugmaker inserts antibody-coding genes into the plant, which are grown in the leaves and then ground up to extract the antibodies.
While growing the antibodies has the potential to cut costs dramatically, it would require investments in new technology, and drugmakers are comfortable with what they currently use. "The technology in use now is very established and extremely efficient … the big companies have made those investments and adopted those systems," biotech consultant Michael Kamarck tells Reuters. "But if you are a small biotech with a great idea, it might make sense to use the tobacco plant to quickly produce antibodies for testing," said Kamarck, who was formerly a manufacturing exec for Merck & Co.
Victor Klimyuk, the COO of Germany-based Icon Genetics, thinks Big Pharma will eventually come around to plant-based drugs, he told Reuters. Icon is working on a cancer vaccine made from tobacco leaves, which Bayer AG was involved in for a while. "It's typical that the Big Pharma industry is very conservative in what they establish and what they invest in."
- read the Reuters story