Genzyme Corporation is one of the world's foremost biotechnology companies and a leader in the effort to develop and apply the most advanced technologies in the life sciences to help patients in nearly 90 countries.

JIM SHUMAN, Senior Vice President of Materials Management at Genzyme Corporation, serves on the Executive Advisory Board of the Grainger Center for Supply Chain Management.

He knows all that goes into manufacturing a safe, efficient product with supply chains that can reach around the globe.

Schuman let us take a close-up look at the supply chain of  one of his firm’s products. Hectorol® (doxercalciferol) is a vitamin D2 analog indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease. Depending on the stage of the disease, it’s offered in capsules and by injection.

Research and Engineering

“Our research starts in Cambridge, Massachusetts, with the discovery phase, where scientists look for opportunities among particular molecules for new treatment and drugs. Then, we progress to research and clinical studies with very small-volume manufacturing providing product. In fact, only 10 percent of these trials ever make it to the commercialization stage, a process that usually takes between five and seven years.”

Sourcing

“Hectorol’s active pharmaceutical ingredients are originally sourced from Teva, in Israel, and are shipped through a subsidiary in New Jersey to a Genzyme facility in Middleton, Wisconsin.  At that point, the they are distributed to plants in Florida and Canada.

The three greatest risk drivers in our sourcing are the fact that our products are biological materials, they may be difficult to locate, and they require strict regulation and quality control.  The difficulty in finding secondary sources would lead to supply shortages if we didn’t take mitigating actions. Genzyme does this by building long-term partnerships and alliances to ensure priority status and/or actively searches for secondary sources. Multiple sourcing introduces cost-versus-volume tradeoffs that we monitor carefully. We also may need to maintain high levels of inventory to ensure availability.”

Manufacturing and Distribution

“The gel capsules are manufactured in St. Petersburg, Florida, and shipped to Rockford, Illinois, where they are packaged and labeled before being inventoried in Tennessee for eventual shipments to wholesaler distribution centers across the country. The IV ampoules and vials/liquid are manufactured, packaged, and labeled in the Montreal, Canada facility so they go directly to Tennessee.

Genzyme products reach hospitals and any of the 80,000 U.S. pharmacies through these wholesale distribution facilities and not directly. Retailers like Wal-Mart and CVS have their own distribution centers that handle the movement through their network.

Because of the nature of our product, a risk is introduced by having customized manufacturing plants and plants that may lack the capacity or ability to manufacture multiple products. Genzyme tries to develop internal capacity to mitigate this and may even arrange external, outsourced, capacity, though we acknowledge that this may be risky in and of itself.”

Regulatory Requirements

“Of course, not meeting FDA regulatory requirements can shut down a plant and cause significant brand and revenue risk.  That is why we tightly manage quality controls and target the highest compliance possible, including being prepared for an FDA visit at any time.”