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Manufacture Bioprocessing - Upstream & Downstream

Plants: the New Medicine Makers

Biopharmaceutical proteins are one of the central pillars of modern healthcare systems. The simplest polypeptides can be produced in bacteria or yeast, but more complex proteins and glycoproteins are produced in mammalian cells – the current gold standard among biomanufacturing platforms. But plants, particularly tobacco due to its biomass yield, are receiving increased attention for the niche product market. Potentially, plants could present greater economy, scalability and sustainability for mainstream biopharma manufacturing. But in the face of strong incumbent technology and intense competition, can these relative newcomers stand their ground?

Biopharmaceuticals include vaccines and prophylactic antibodies for disease prevention, labeled antibodies and ligands for disease diagnosis/monitoring, and diverse therapeutic proteins ranging from replacement enzymes and hormones, to antibodies that target and destroy cancer cells. Some of these proteins, such as insulin, serve large markets, but the vast majority, including most antibodies, are indicated for diseases with a relatively low incidence. In these cases, the entire annual global demand is typically in the kilograms to hundreds of kilograms range. A few antibodies have achieved blockbuster status and the demand for these exceptional products is several tonnes per year, but if we want to use antibodies for the prevention, diagnosis or treatment of more widespread illnesses, including Alzheimer’s disease, malaria or HIV/AIDS, then demand may increase to 100 tonnes per year or more for each product. Meeting such demand will be difficult using microbes or mammalian cells because the scalability of a production suite is limited by the working volume of today’s largest bioreactors, typically 20,000 L for conventional stainless-steel fermenters and 2000 L for single-use alternatives. Assuming optimal yields, constant campaigns and consistent perfect performance, such facilities would produce 7.5 and 0.75 tonnes per year, respectively (1).

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About the Author

Johannes F. Buyel

Johannes F. Buyel is head of the Integrated Production Platforms department at the Fraunhofer Institute for Molecular Biology and Applied Ecology IME, and senior scientist at RWTH Aachen University, Germany.

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