Tuesday, November 10, 2009 - 8:30 AM
S25

Transferring fermentation process methods from R&D to the manufacturing scale

Anthony Calabria1, Caroline Peres1, and Joke Van Langeraert2. (1) Microbial Physiology and Fermentation, Genencor, a Danisco Division, 925 Page Mill Rd., Palo Alto, CA 94304, (2) Genencor Global Engineering, Genencor, a Danisco Division, Komvest 43, 8000, Brugge, Belgium

Genencor, a Danisco Division, discovers, develops, manufactures, and delivers enzyme product solutions for the food and feed, agri processing, cleaning and textiles, consumer, and industrial markets.  It also develops innovative advancements for the biofuels, biodefense, and biosafety industries.  Genencor’s 8 manufacturing facilities produce 250 diverse protein products in 30 to 360 thousand liter fermentors for customers around the world.  Maintaining this capability requires an efficient system that allows new products and processes developed at the R&D scale to be rapidly transferred to manufacturing sites.  Product introductions and process changes are accomplished at Genencor using a process of commercialization including technology transfer.  Technology transfer is greatly facilitated by recapitulating the manufacturing site, fermentation process at the R&D scale to a degree that allows proper evaluation of production variables such as pH, feed rate and media composition.  The goals of the technology transfer team can then include the generation of representative, small-scale process data and the identification of sensitive process variables prior to the initial manufacturing plant trial.  A rapid and successful transfer is most feasible when a holistic approach tracks fermentation changes through the entire production process at the R&D scale.  The technology transfer of the production process for the G4 amylase, an anti-staling baking amylase, is the case study used to illustrate Genencor’s transfer process with a real-world example.

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