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Monoclonal antibody (mAb) therapy is a form of immunotherapy that uses mAbs to bind mono-specifically to certain cells or proteins. This may then stimulate the patient's immune system to attack those cells. MAbs are currently used to treat medical conditions such as cancer, diabetes, arthritis, psoriasis, and Crohn’s Disease, but have the potential to treat countless diseases and disorders. In 2015, the mAb market was valued at $85.4 billion, and is expected to reach $138.6 billion by 2024.1 In manufacturing, mAbs are typically produced in suspension in a series of fed-batch bioreactors using genetically engineered cells originally obtained from Chinese Hamster Ovaries (CHO).2 In this proposal, two upstream bioreactor designs were analyzed for economic comparison given an annual production goal of 100 kg of mAb, with the first design culminating in a 20,000 L volume at low mAb titer and the second design culminating with a 2,000 L volume at high mAb titer. Following upstream mAb production, the protein was purified to meet clinical FDA standards using a series of downstream purification techniques, including centrifugation, filtration, and chromatography. The two designs can be modeled for both an on-patent and off-patent mAb in order to ensure long-term economic viability. In this project, the drug was modeled based on Ocrevus (ocrelizumab), a humanized therapeutic mAb brought to market in 2017 that targets a CD20-positive B cell to treat the symptoms of both primary progressive and relapsing Multiple Sclerosis.3 For an off-patent drug, it is recommended that the mAb be priced at $35,000 per 1200 mg annual treatment in order to earn a 15% Internal Rate of Return (IRR) within 5 years of market uptake. For an on-patent drug, a price of $65,000 per 1200 mg treatment should be used to recover the R&D costs of developing a new drug and sunk cost of past unsuccessful drugs. After analyzing both designs, it was concluded that the second, smaller design scheme is more scalable, less risky, and more cost effective for the production of both the on- and off-patent drugs.
Date Posted:20 April 2018