Emerson helps Genzyme speed key drugs to market, slash startup time of biopharmaceutical plants
PlantWeb automation technology and Genzyme's advanced thinking reduce validation time and cost. The technology of PlantWeb has been applied to dramatically reduce the time and cost of validating the automation software running Genzyme's new and updated manufacturing plants. Genzyme is one of the world's largest global biotechnology companies. It is a leader in developing and manufacturing therapies that improve the quality of life of patients around the world who suffer from rare genetic diseases.
The joint Emerson-Genzyme effort has grown from an initial project that delivered re-control of a microfiltration skid in 2000, to a strategic approach for the automation of all aspects of new Genzyme manufacturing plants. The software development and validation techniques employed, as well as the technology that made it possible, will help shave 6-12 months off new plant startup dates compared to using conventional validation methods.
"Three enormous benefits result," reports Phillip Maderia, Genzyme's Associate Director of Automation Engineering. "First, Genzyme's ROI will begin earlier, mitigating some of the risk in building new plants. Second, the cost of validating the automation software will be substantially reduced. Third, and most exciting, for new rProtein drugs in the FDA approvals process, Genzyme will get them to market earlier, and patients will have them sooner."
"Key to achieving the time savings," according to Maderia, "is the ability that Genzyme now has to validate the software before automation equipment is installed, as opposed to after its installation. Pre-installation validation requires a combination of technology and method to assure that the application software's development, testing, and documentation is complete and unassailable. Neither technology nor method alone can bring success. And, it's a strategic combination that can't be created overnight."
It has taken Genzyme three years to create the new procedures and validate modules for 95% of all control elements typically used in a biotech plant. The effort began by validating standalone equipment such as skids. It then graduated to partial production lines and finally to entire lines and plants. Each project required that additional modules be developed. Obviously, the upfront effort was high. But today, Genzyme is reaping solid returns by leveraging the validated modules, calling Instances of them over-and-over to quickly and efficiently automate equipment and production lines before installation.
"Genzyme has demonstrated foresight and leadership in tackling some of the greatest challenges facing the Life Sciences industry, and we are honored to be part of this success," commented John Gardner, Process Systems Vice President, Emerson Process Management. "The team of Genzyme technologists and Emerson's pharmaceutical industry center experts have applied the technology of DeltaV software and PlantWeb architecture to deliver validated, modular software that Genzyme is able to apply across multiple projects — that's exciting for Emerson as well as Genzyme and its customers."
"Our ability to apply these validated modules over and over enables cost efficiencies and earlier startup dates," Maderia concluded. "Unlike the past, validation is no longer the antithesis of automation. This new strategic software approach will help us keep automation off the critical path of the project."
About Genzyme
Genzyme Corporation (www.genzyme.com) is a global biotechnology company dedicated to making a major positive impact on the lives of people with serious diseases. The company's broad product portfolio is focused on rare genetic disorders, renal disease, osteoarthritis, and immune-mediated diseases, and includes an industry-leading array of diagnostic products and services. Genzyme's commitment to innovation continues today with research into novel approaches to cancer, heart disease, and other areas of unmet medical need. More than 5300 Genzyme employees in offices around the globe serve patients in over 80 countries.
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