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Working Paper

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Due to their high specificity and the wide range of treatments they can provide, monoclonal antibodies (MAbs) from mammalian cell cultures have gained increasing popularity in therapeutics. As a result, treatments have become cheaper and easier to manufacture while maintaining their natural effectiveness, further increasing their appeal. Building MAb manufacturing facilities can be costly for biopharmaceutical companies, especially smaller biotech firms, and current production capacities are limited. As a result, there is an everincreasing demand for contract development organizations (CDOs). The CDO being proposed targets demand within this regime specific to MAbs entering clinical trials. It has the capability to screen clones, grow MAb-producing cells up to a 2500 L culture, and purify the MAb to clinical standards. By employing the newest technology available, the facilities will provide flexibility necessary for producing a myriad of different MAb therapeutics in Chinese Hamster Ovary (CHO) cells. Microbioreactors can screen dozens of clones at the millileter scale, saving time and money. Disposable bioreactors in the upstream process allow for variance in the production capacity due to the range of sizes they are available in. Finally, the purification process has been designed to allow for flexibility depending on the size and needs of every client’s product to maximize value to the costumer as well as the company.

The current market for MAb production has an astounding worldwide value of approximately $27.5 billion and continues to expand as the number of MAbs entering clinical trials increases (Cowen 2006). It is estimated that within the next four years that the worldwide market value will reach $50 billion (“Preclinical Development”, 2010). The profitability of this proposal is based on running 39 batches a year at 4.326 kg MAb/batch or 168.71 kg MAb/year. By charging a reasonable average of $1,125,000/kg MAb, a profitability profile can be created. Assuming a 70% production capacity and a ten year plant life, the ROI, NPV and IRR of the project are 115.83%, $111,907,800 and 52.96% respectively. However, using a 70% production capacity also leaves room for even higher profit margins. The plant design also has space allotted for future expansion within the mammalian suite as well as room for a future microbial suite.

Previous Versions

Nov 18 2010



Date Posted: 18 November 2010