Large-scale manufacturing at Regeneron is performed under strict cGMP (current Good Manufacturing Practices) conditions. Independent clean room suites with ultra-modern clean utilities support various sized cell culture bioreactors and large-scale chromatography systems designed to produce and purify the Company's product candidates.
The large-scale cell culture and purification facilities are used to manufacture the Company's late-stage product candidates. The manufacturing staff's extensive experience is supported by a technical staff of scientists, engineers, technicians, and managers. They provide Regeneron with the necessary expertise to develop, operate, optimize, validate, and license the complex manufacturing processes required for production of biopharmaceuticals.
The Regeneron quality assurance staff oversees all cGMP activities and operates using up-to-date quality systems built on previous experience as an FDA-approved contract manufacturer. Our quality control laboratories 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.