Industrial Operations

LEADERS IN INDUSTRIAL
OPERATIONS AND PRODUCT SUPPLY

Grounded in excellence and driven by innovation, our Industrial Operations and Product Supply (IOPS) team is responsible for the production of Regeneron's medicines.

IOPS successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies.

Our operations follow strict adherence to current Good Manufacturing Practices (cGMP) and use cutting-edge analytical equipment, automated laboratory information management systems and electronic document management systems, all of which are supported by an extensive calibration, validation and preventive maintenance program. Our independent clean-room suites with ultra-modern clean utilities support both single-use and stainless steel cell culture bioreactors and large-scale chromatography systems designed to produce and purify our product candidates.

Industrial operations video

Supported by a highly skilled team of professionals, our integrated teams bring an unsurpassed expertise in developing, operating, optimising, validating and licensing the complex manufacturing processes required for production of biopharmaceuticals.

Take a behind-the-scenes look at how we produce the highest-quality medicines for patients as efficiently as possible.

The Regeneron difference

Our dedicated IOPS team turns cutting-edge science into innovative biologic medicines to improve the lives of patients worldwide. Our commitment to operational excellence and patient safety ensure we consistently produce the highest-quality medicines. Click through the manufacturing process steps below to learn how we turn science into medicine.

From cells to life-changing medicines
Vile of identical cells growing and multiplying. Cells growing and multiplying.
Cell line expansion

The manufacturing process starts with a vial of identical cells that grow and multiply under the watchful eye of specialists.

Controlled bioreactor environment. Cells continuing to grow in a controlled bioreactor environment.
Production

Cells continue to grow for a specified amount of time in the controlled bioreactor environment to produce an optimal amount of the target protein.

Separating protein and media from cellular debris through centrifugation. Separating protein and media from cellular debris by a sequence of increasingly fine filters.
Harvest

The harvesting process separates protein and media from cellular debris, first through centrifugation and then by a sequence of increasingly fine filters.

The target protein is isolated, purified and concentrated. The target protein is isolated, purified and concentrated (close image).
Purification

The target protein is isolated, purified and concentrated in a multi-step process to ensure it is of the highest quality.

Buffers are added to maintain the therapeutic protein at a desired concentration. Product is dispensed into containers to ensure stability through the entirety of the drug’s shelf life.
Formulation & dispensing

Buffers are added to maintain the therapeutic protein at a desired concentration. Then, product is dispensed into containers to ensure stability through the entirety of the drug’s shelf life.

The formulated drug is labeled and packaged for distribution. The formulated drug substance is filled into the appropriate vials or syringes.
Filling, packaging & labeling

From IOPS, the formulated drug substance is filled into the appropriate vials or syringes, labeled and packaged for distribution.

Industrial Operations and Product Supply
The Shingo Prize for operational excellence

In 2019, IOPS Rensselaer was recognized by the Shingo Institute with their highest award, the prestigious Shingo Prize, for operational excellence. Learn how we challenge the status quo and foster a culture where continuous improvement is not just a metric — it's a mindset for everyone, every day to do better.

A long-term global commitment

IOPS has been manufacturing large-scale biologics since 2003, and has a long-term commitment to manufacturing growth and expanded operations across the globe.

The Rensselaer, NY facility has grown at a rapid pace since its acquisition in 1993. In 2018, Regeneron committed to invest up to $800 million and create 1,500 new full-time jobs in the greater Capital Region by the end of 2024.

Since 2014, Regeneron has invested more than $1 billion to transform a vacant former computer manufacturing factory into the largest bulk biologics production facility in Ireland. Today we are among the areas largest private employers helping drive economic growth in the region.

The Shingo Prize logo
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