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 products.
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.
Supported by a highly skilled team of scientists, engineers, biotech production specialists and managers, our integrated teams bring an unsurpassed expertise in developing, operating, optimizing, validating and licensing the complex manufacturing processes required for production of biopharmaceuticals.
We embrace our role — and the immense responsibility it carries — to produce the highest-quality medicines for patients as efficiently as possible.
Our dedicated Industrial Operations and Product Supply (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. Download the full process graphic.
FROM CELLS TO LIFE-CHANGING MEDICINES
- Cell Line Expansion
- Formulation & Dispensing
- Filling, Packaging & Labeling
CELL LINE EXPANSION
The manufacturing process starts with a vial of identical cells that grow and multiply under the watchful eye of specialists.
Cells continue to grow for a specified amount of time in the controlled bioreactor environment to produce an optimal amount of the target protein.
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 in a multi-step process to ensure it is of the highest quality.
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.
FILLING, PACKAGING & LABELING
From IOPS, the formulated drug substance is filled into the appropriate vials or syringes, labeled and packaged for distribution.
THE SHINGO PRIZE FOR OPERATIONAL EXCELLENCE
In 2019, Industrial Operations and Product Supply (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.