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Contract Fermentation Landscape: Facility Selection in an Environment of Limited Options

Submitted by on April 12, 2018 – 10:28 amNo Comment

by  Mark Warner (Warner Advisors LLC/Biofuels Digest)  Funding for early stage advanced biotechnology is ramping up and companies commercializing fermentation-based technologies are faced with the decision to either build their own demonstration-scale facility or utilize existing contract manufacturing organizations (CMOs). There are clear benefits of using CMOs, however conducting a successful CMO search is much like preparing for a difficult hike, the most important factor going in is having the right mental perspective to understand the challenge that lies ahead.

It is important to understand what a CMO is and is not. In the world of biotechnology, a CMO is a manufacturing facility with aseptic fermentation and downstream recovery to make a range of products from microbes. Implied in the name is that these are primarily manufacturing facilities that have long term agreements to make products (primarily pharmaceuticals) from processes with an operational history and have successfully been scaled-up. By contrast, most emerging biotechnology companies looking to do scale-up work, are seeking shorter term arrangements (as low as just a few fermentation runs) to prove their technology and produce samples for potential clients. While CMOs can successfully support scale-up work, it is usually a small subset of the CMO world and finding the right partner is a complicated and time-consuming journey. Some lessons-learned based perspective is as follows:

Don’t be a “5” looking for a “10” 

Clearly define your goals

Start at the end and work backwards 

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