Development of a Plant-Made Pharmaceutical Production Platform Using Single-Use Materials and an Aquatic Plant

Since the late 1980s, studies have shown that plants can manufacture functional transgenic pharmaceutical compounds. Advantages attributed to plant-made pharmaceutical (PMP) approaches are compelling, and PMP production continues to attract interest from investors and the biopharmaceutical industry (Table 1). Proposed PMP benefits include proven scalability, high production capacity, limited exposure to human or animal pathogens, lower capital expenditures (CapEx), and decreased operating costs. Those putative advantages have proven to be significant business forces driving continued investor support for PMP ventures. PMP production’s lower cost relative to cell culture provides an opportunity to subsidize more research for additional product development. Placed in wider context, the business value, for example, of potentially large production capacity coupled to lower CapEx requirements and manufacturing costs is underscored by concerns over the expanding gap between production volume and patients’ needs for potentially life-saving drugs. In 2010, 178 drug shortages were reported to the US FDA, 132 of which involved sterile, injectable drugs. In 2011, the agency has continued to see an increased number of shortages, especially those involving older sterile injectable drugs (1). So the disparity between production and capacity continues to expand. Many situations can create a drug supply shortage, including natural disasters, limited profitability, regulatory activities, and populationbased demands. One compelling solution to the growing difference between drug production capacity and patient needs is taking advantage of the simplicity, lowered cost of goods (COGs), increased speed, and greater capacity offered by PMPs. Other PMP manufacturing advantages are operational and relate, for example, to the risk of animal by-product exposure to cultures, feed streams, and/or active pharmaceutical ingredients (APIs). Manufacturers must demonstrate that their processes and APIs are free of biologically active animal by-products if they are to be approved. For example, prions and viral particles associated with animalbased products may cause serious adverse reactions in humans when injected or ingested. Such exposure can be minimized in well-designed processes using plant-based production cultures and USP Class VI certified components. With PMP systems, however, the serious concern over animal by-product contamination is reduced or removed completely. They have less inherent animal by-product exposure, thereby eliminating the need for the additional expense of removing associated contaminants. The end result can be simpler, less-expensive processes with more rapid production and development timelines.