The JV will begin its foray into biosimilars by developing a version of the oncology drug Avastin(bevacizumab), in collaboration with the Fraunhofer Center for Molecular Biology in Newark, Delaware, which will produce the active pharmaceutical ingredient for clinical trials.
The JV is also expected to build a pilot biopharma manufacturing facility in Brazil that will see its upstream activities based in plants rather than mammalian cell culture.
“We’re building a pilot scale facility and in the longer term, we’ll build a full commercial facility, which will be adjacent to an existing facility focused on mammalian cell cultures,” Don Stewart, PlantForm’s President and CEO, told us.
He also explained to BioPharma-Reporter.com about how the tobacco plant-based manufacturing system works.
“The main system uses plants as bioreactors instead of fermentation technology,” Stewart said. “We’re conducting expression in tobacco plants instead of mammalian cell cultures – and can make both glycosylated products and non-glycosylated proteins. The system is very simple in terms of scalability but one of the main advantages is the cost of manufacturing – we estimate that our cost of producing a biosimilar of Herceptin is about 1/10th cost of Roche cost of producing it.
Scalability is also an advantage for the plant-based manufacturing system, Stewart said, noting that because each plant is the same it’s “different from fermentation where as you increase scale of bioreactor, everything changes.”
Traditional methods of producing protein-based drugs in plants can take several years to produce seed lines for homogeneous, commercial-scale production. PlantForm, however, has reduced its product development timeline by introducing genetic material to the plant using a transient expression system. After the genetic material is introduced, target protein production occurs immediately and peaks within one to two weeks, after which the plants can be harvested for product purification.
“Tobacco grows extremely well indoors in fully contained environment,” Stewart said.
PlantForm has also developed stable transgenic plants for biosimilar drug production and is testing the first products produced from this proprietary system. These plants express high concentrations of the antibody and require only light, soil, water and fertilizer for production.
“Our primary focus is to expand range of biosimilars we’re working on – the big highly comparative ones,” Stewart added. The company is also looking to include “more orphan or niche biosimilars made from our own platform. We’re seeking more collaborations and contracts with biopharma.”
He also cited analysis showing that to build a facility for producing mAbs in mammalian cells is about $250m (in order to produce $1bn of Herceptin), whereas the same plant-based facility is about one-fifth of the cost.