After years of laboratory research, clinical trials, and regulatory scrutiny, an approved product must be safely and reliably produced for distribution to patients. At Sanofi Genzyme, we manage global manufacturing operations as part of our ongoing commitment to product quality and accessibility.
Many of Sanofi Genzyme's products are biologics, which means their manufacture is a lengthy process involving delicate living cells that are highly sensitive to their environment and even the smallest of changes in the production process.
We were one of the industry’s earliest innovators in large-scale commercial production of therapeutic enzymes using recombinant DNA technology. Over the years, we’ve continued to develop our capabilities in these complex biologic production techniques, enabling us to create effective therapeutics for patients with diseases caused by missing or malfunctioning enzymes.
Producing Proteins: An Inside Look
By inserting into living mammalian cells a human gene that directs the production of a particular enzyme, we essentially turn those cells into tiny "factories" that produce the enzyme, which can then be harvested and purified for medical use in humans.
Sanofi Genzyme facilities also manufacture many different therapeutic products for other divisions within Sanofi that vary widely in the medical conditions they treat and in how they are made. We also make use of these diverse in-house manufacturing capabilities to manufacture experimental products across varied medical technology platforms for use in clinical trials – such as genetically engineered viral vectors to test potential gene therapies. Developing these production techniques during the research phase can help with the transition to commercialization should research yield an approved, marketable product.
To optimize our manufacturing operations and best serve patients globally, Sanofi Genzyme has specialized facilities around the world. We also partner with select contract manufacturing organizations to supplement our in-house production capacity.
Looking to the future of our manufacturing operations, Sanofi Genzyme is focused largely on increasing our production capacity in order to meet the treatment needs of the patient populations reliant on our enzyme replacement therapies.
Our current manufacturing expansion plans are focused primarily on adding cell culture equipment and production bioreactors at two key protein manufacturing facilities: Geel, Belgium, and Framingham, Massachusetts. With these infrastructure expansions, we are targeting a fourfold increase in our ability to manufacture our enzyme replacement therapies over time.
In 2010 and 2011, Sanofi Genzyme brought in experienced new leadership to drive our manufacturing efforts. We continue to explore new process engineering methods, safety protocols, and other ways to help us in our mission to bring safe and effective treatments to patients.