Large-scale Manufacturing Under Strict cGMP Conditions
Regeneron manufacturing is performed by a dedicated staff of experienced professionals. 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 facility is 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.
Quality Attributes Maintained at All Stages of the Process
Regeneron has a knowledgeable quality assurance staff that 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 testing capabilities include advanced methods for HPLC, Gel Electrophoresis, CE, FTIR, PCR, cell-based assays, and rapid microbial identification, as well as a variety of basic chemical, microbiological, and drug quality assays. Our quality control laboratories use cutting-edge analytical equipment, automated laboratory information management systems (LIMS), and electronic document management systems (eDMS), all of which are supported by an extensive calibration, validation, and preventive maintenance program.
Warehouse Operations
The Regeneron cGMP warehousing operation is located adjacent to the commercial-scale manufacturing suite. Operations, sampling, testing, and material flows are strictly controlled by quality assurance-approved standard operating procedures. Inventory control, raw material, and product lot traceability are maintained with a validated database. To protect and secure the biopharmaceutical products produced at Regeneron, the warehousing operation utilizes numerous walk-in style temperature-controlled boxes equipped with back-up power, redundant refrigeration systems, secured access, and a continuous monitoring system that is capable of paging the technicians for around-the-clock service.