FermWorksAccelerating the Commercialization of New Bio-therapeutics “Using FermWorks, BioMarin has realized a 30% savings in time, resulting in substantial development cost reductions.” Jim Michaels Director, Cell Culture & Fermentation Development BioMarin Pharmaceutical, Inc. BioMarin develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions. BioMarin is a publicly held company with a market cap of $665 million and 310 employees (9/05). The Challenge BioMarin Pharmaceuticals used the traditional, inefficient, and error-prone “clipboards and pens” process to collect instrument data in its development and pilot perfusion laboratories. This hand-collected data was entered manually into Excel spreadsheets for analysis and process control decisions. The process set points were then manually changed on each instrument. The need to integrate data from a mixture of legacy instruments, obtained during an acquisition, further complicated the old- fashioned process. The Solution WireWorks West’s FermWorks 2.1 gives BioMarin a comprehensive software solution for process control and data management that automatically aggregates and integrates the information from the laboratories’ mixed groups of Applikon, NBS and Sartorius (B.Braun) bioreactors and all other “open” on- and off-line instruments. FermWorks automates process control, allowing flexible, customized control strategies and real-time analysis for process feedback. The results “Using FermWorks, BioMarin has realized a 30% savings in time, resulting in substantial development cost reductions.” The FermWorks automated process control system unifies, integrates, and archives all the recorded and available information from the cell culture and fermentation labs. This increases researchers’ efficiency and allows them to focus on improving methods and yields, key elements in overall profitability of the organization. “FermWorks provides flexibility, customization, data analysis, and data review that are very accessible and very well done”, Jim Michaels, Director of Cell Culture and Fermentation Development at BioMarin The Challenge BioMarin Pharmaceutical is a Northern California-based biopharmaceutical organization that commercializes innovative biopharmaceuticals for serious diseases and medical conditions. BioMarin researchers, in the process R&D and pilot plant perfusion labs, collected data and managed recipe development for new drugs in the tried-and-true, old-fashioned way. To monitor the development process, they walked around the lab recording data on a clipboard from each instrument, and then manually entered all the data into an Excel spreadsheet. Based on their analysis of this aggregated data, they returned to each controller to adjust the recipe process by hand, in order to optimize the recipe for maximum effectiveness and best yield. This approach was, “Inefficient and error prone,” according to Jim Michaels, Director of Cell Culture and Fermentation at BioMarin. As the result of a company acquisition, BioMarin obtained a mixed set of very expensive cell culture and fermentation instrumentation. These acquired instruments, added to those already in the lab, resulted in an assorted mixture of various vendors’ instruments, including biocontrollers from New Brunswick, Sartorius (B.Braun), and Applikon. Each vendor’s instrument had its own proprietary control software and none of the instruments “talked” to the others. The data aggregation, integration, and analysis became even more cumbersome. The Solution WireWorks West’s FermWorks 2.1 gives BioMarin a comprehensive software solution for distributed process control and data management of all of the “open” instruments in their development and pilot laboratories. FermWorks’ networked supervisory process control aggregates and integrates the information from the labs’ mixed group of Applikon, NBS and Sartorius (B.Braun) bioreactors and other “open” (on- and off-line) instruments. In addition, FermWorks automatically monitors and controls the cell culture and fermentation processes, based on parameters set by the BioMarin research scientists. BioMarin, with WireWorks West’s assistance, was able to quickly customize specific control inputs and outputs for both continuous perfusion and fed-batch control. The Results Research scientists at BioMarin are now able to focus on perfecting methods and yields, rather than data collection and data entry. Jim Michaels, Director of Cell Culture and Fermentation at BioMarin, is enjoying the benefits of FermWorks in his organization. He says, “FermWorks’ organization and ease of use provides true operational savings. Using FermWorks, BioMarin has realized a 30% savings in time, resulting in substantial development cost reductions. FermWorks’ automated process control system unifies all of the recorded and available information for cell culture and fermentation instruments, successfully integrating and archiving all information ‘for the record’. This previously involved inefficient and error prone cutting & pasting. FermWorks provides flexibility, customization, data analysis, and data review that are very accessible and very well done.” About BioMarin Pharmaceuticals: BioMarin is a publicly held company (Nasdaq: BMRN) with a market cap of $665 million and 310 employees (9/05). BioMarin develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions. The company’s product portfolio comprises three approved products and multiple clinical and preclinical product candidates. Approved products include Naglazyme (galsulfase) for mucopolysaccharidosis VI (MPS VI), a product wholly developed and commercialized by BioMarin, Aldurazyme (laronidase) for mucopolysaccharidosis I (MPS I), and Orapred (prednisolone sodium phosphate oral solution) for inflammatory conditions. Investigational product candidates include Phenoptin(TM) (sapropterin hydrochloride), a Phase 3 product candidate for the treatment of phenylketonuria (PKU). For additional information, please visit www.BMRN.com.