BioMarin
Company Snapshot
Company Overview
BioMarin Pharmaceutical Inc., established in 1997, is a world leader in developing and commercializing first- or best-in-class therapies for rare genetic diseases. The company takes pride in pioneering breakthrough treatments for debilitating and life-threatening conditions. BioMarin Technical Operations (TOPS) is an experienced, responsive and agile organization developing and manufacturing safe and effective medicines. From enzymes to gene therapy, the company has its own manufacturing approach, maintaining the highest quality standards, along with efficient production and delivery to meet clinical and commercial demands.
BioMarin facilities include three cGMP (current good manufacturing practices) manufacturing plants across Novato, Calif. and Shanbally, Ireland. The facilities offer dedicated cGMP process manufacturing, quality control and R&D laboratory space. BioMarin is a pioneer in gene therapy manufacturing and built one of the first gene therapy manufacturing facilities of its kind, spanning 18,000 feet, with the ability to produce up to 10,000 doses per year.
The company’s products include Palynziq (pegvaliase-pqpz) injection for phenylketonuria (PKU), Brineura (cerliponase alfa) for late infantile neuronal ceroid lipofuscinosis type 2 (CLN2) disease, Vimizim (elosulfase alfa) for mucopolysaccharidosis IVA (MPS IVA), Kuvan (sapropterin dihydrochloride) tablets for PKU, Naglazyme (galsulfase) for MPS VI and Aldurazyme (laronidase) for MPS I.