Industrial Operations LEADERS IN INDUSTRIAL
OPERATIONS AND PRODUCT SUPPLY

Welcome to Industrial Operations and Product Supply, or IOPS, the manufacturing and supply arm of Regeneron.

Let's take a behind-the-scenes look at what it takes to optimize and produce our life-changing medicines for patients around the world. It starts with cell line expansion, where a vial of frozen identical cells is thawed under the watchful eye of our specialists. We then transfer those cells to a vessel-containing media, which is a nutrient-dense solution that helps promote cell growth. As the cells grow and multiply, we move them into progressively larger bioreactors.

The bioreactors used in production, support a biologically active system, that gives our cells the space to grow and expand up to 10,000 liters. Toward the end of production, we change the conditions in the bioreactor to make the cells stop growing, and, instead, begin to release our target proteins, the active ingredient in our medicines. During this time, our specialists are continuously monitoring the cells, they add solutions and additional media, as well as take samples to ensure we meet the highest quality standards, and achieve a desired concentration of our target proteins.

Once the cells have released enough proteins, it's time for the harvest operation. During harvest, we sample the cell solution to make sure there are no potential viruses, and then separate the proteins and media from cellular debris and any other unwanted particles. Throughout purification, we use chromatography methods to continue to extract our target proteins from remaining media, making sure we also leave behind any remaining cell debris and waste. Then, using viral clearance techniques, we remove any potential viruses, and, finally, concentrate the proteins for optimal product safety and efficacy during concentration and diafiltration.

After spending about five weeks in production, the drug substance is formulated for stability. Our specialists then dispense this formulated drug substance into containers, where it is frozen and stored until it is ready for filling, labeling, and packaging. To fill our medicines into vials, or syringes, for appropriate patient dosing, we partner with a variety of contract manufacturing organizations. They label, package, and distribute our medicines for use by physicians and patients around the world.

Regeneron is committed to delivering life-transforming medicines to people with serious diseases. Through our culture of continuous improvement, we deliver high-quality biopharmaceuticals to patients as efficiently as possible.