By Michael Butler
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Monoclonal antiBody Production The business of
MabNet ran a course on the Business of Monoclonal Antibody Production at the Biotech Research Institute, Montréal. Pictured above are the 65 participants. MabNet, the national Monoclonal Antibody Network sponsored an advanced course: “The Business of Monoclonal Antibody Production” at the NRC-Biotechnology Research Institute, Montréal September 10-11, 2012. The advanced course was designed to provide education and training on industrial and business aspects of monoclonal antibody production. There were approximately 65 delegates in attendance that included 30 experts from industry and government and 35 MabNet trainees. The Natural Sciences and Engineering Research Council of Canada (NSERC) provided support for the course, including travel for MabNet trainees, through a grant under the Strategic Network Enhancement Initiative. The objective was to ensure that all participants gained a grasp of the implementation of state-of-the-art Monoclonal Antibody (Mab) technologies in an industrial setting. Business, financial and intellectual property issues were also covered, providing a comprehensive review aimed at current and future business executives and industry managers. The course was organized as a series of lectures delivered by invited speakers from the bio-industry and included discus24 BIOTECHNOLOGY FOCUS NOVEMBER 2012
sion following formal presentations at the end of each day. Opening the meeting were Michael Butler, MabNet Scientific director, who emphasised the important role of a national network like MabNet in enhancing the biotechnology industry in Canada and David Shindler, chair of MabNet’s board of directors, who noted that during the very early development of monoclonal antibodies, the technology was dismissed as of no commercial value when first assessed for patent protection! The first speaker, Marcel Mongeon gave an exceptionally lively opening lecture on patent law and practice. Describing himself as an “Intellectual Property Coach,” Mongeon elucidated the basic requirements to establish a patent. Using relevant examples he demonstrated the necessity to establish novelty and utility of an invention but cautioned on the complexity and cost of establishing patents worldwide. Only a small proportion of all patents (probably < one per cent) recover the costs of filing and become money earners. Nevertheless, industry executives and managers must establish patent portfolios and protect inventions in order to be world-competitive.
There followed a series of lectures on the business basis of contract manufacturing in biotechnology. Jason Dowd of Apotex described the challenges that can exist between client and provider. The client can often be a virtual company that may well underestimate the full financial cost of development of a novel product. Bioprocess scale-up often comes the competing challenges of maintaining high productivity and product quality assessed by for example the degree of sialylation of a glycoprotein. Challenges of developing a biosimilar can be associated with misinformation of the correct amino acid sequence because of discrepancies in available databases. Gregor Awang of Cangene developed these points by emphasising the need to establish realistic end-points at each stage of scale-up. There are various choices to be made in developing a potential glycoprotein product including the choice of cell line and the control of the defined serum-free media. Strategies that avoid intellectual property issues are important. The quality profile of the final product needs to be monitored closely to ensure consistency as scale-up is developed from cell banks, shake flasks and to larger multiple liter bioreactors. Devender Sandhu of Therapure then explained the business strategy associated with custom manufacturing organizations (CMOs). The number of licensed biologicals is increasing rapidly. This includes an explosion of interest in drug conjugates with the ability to bind to two separate receptors. This increase in products has enhanced the importance and need for CMOs. The growth of the client base of Therapure in Toronto was described as an example of a rapidly expanding CMO. Richard Mateles, an independent biotechnology consultant from Chicago expanded this theme by explaining that contracting out specific tasks for bioproduction is a common industry practice, as there are only a few stand-alone CMOs globally. Ziawei Fung of GE Healthcare gave a description of the importance of downstream processing as a stage in bioprocessing. High throughput methods have been developed by GE and designated as Fasttrack technology. This offers possibilities for rapid and
