Mapping the Way to Innovation

By Michele Vaccarello, Digital Managing Editor Since its founding in 1981, Genzyme Corp. has prided itself on a strong base of innovation (Box, below). The company now has over 70 facilities operating in over 30 countries, including 17 manufacturing plants and nine genetic testing laboratories, and a technology platform that encompasses protein, cell and gene therapies, monoclonal and polyclonal antibodies, genetics, small molecules, biomaterials, therapeutic polymers and rapid diagnostics (Box, below). Approved for commercial production by the FDA in 1996, Genzyme Corp.’s Allston Landing Facility in Allston, Mass. is one of the largest cell-culture manufacturing plants in the world. The 185,000-sq.-ft. plant, which produces orphan drugs for rare diseases, employs 400 people. It first began producing Cerezyme, an enzyme replacement therapy for Type 1 Gaucher disease, in 1996. Today, Fabrazyme, an enzyme replacement therapy for Fabry disease, and Myozyme, an enzyme replacement therapy for Pompe disease, are also made at the plant. Increasing manufacturing capacity by 50% in 2005 allowed for additional simultaneous cell-culture and purification, and the plant currently boasts a 12,000-L perfusion capability. Although the facility has no formal Six Sigma or Lean initiatives under way, its management is committed to a continuous improvement program that uses tools from both methodologies, selecting those that are most relevant to each specific stage of manufacturing and quality control (QC). Utilizing detailed process mapping and cycle time analysis, manufacturing professionals at the plant have eliminated nonproductive steps, says Frank Byron, vice president and site manager at Allston. Meanwhile, both manufacturing and QC teams analyze first-pass yields and corrective and preventive actions (CAPA) to prevent any deviations. The facility is now investigating rapid microbiological analysis, Byron says, as well as implementation of a new finite scheduling system, which he believes will optimize and integrate its production and maintenance scheduling technologies. At Allston, employee-directed cross-functional improvement teams use tools that include statistical process control charting, statistical analysis on process variables and a process data historian that captures key process variables, to analyze process trends. Trend data are distributed to all via an interactive intranet system, Byron says, and plans call for an integrated process monitoring system to be installed at the plant in the future. QC is key to operational excellence at the Allston facility, and the typical validation run for any product at the facility averages 100 days. Media preparation, the first step