We take pride in manufacturing complex therapies for the patients who need
BioMarin Technical Operations (TOPS) is an experienced, responsive and agile organization with a proud connection to our patients – developing and manufacturing safe and effective medicines that we consistently deliver to those in need.
From enzyme to gene therapy, our owned manufacturing approach allows us to maintain the highest quality standards, along with the efficient production and delivery capability to meet clinical and commercial demands.
Our facilities include three cGMP (current Good Manufacturing Practices) manufacturing plants across Novato, California, and Shanbally, Ireland. The facilities offer dedicated cGMP process manufacturing, quality control, and research and development laboratory space.
Pioneers in Gene Therapy Manufacturing
At the forefront of one of the newest advancing fields in biotechnology, we 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. In 2018, the International Society for Pharmaceutical Engineering (ISPE) selected our facility from 30 sites across the globe as the winner of the Facility of the Year Award® in the Project Execution Category. Projects selected in this category exemplify the application of novel tools and approaches to improve efficiencies and effectively overcome challenges.
Making a Habit of Quality: How Technical Operations Paved the Way for BioMarin’s Success
In the book, Dr. Baffi details the critical role of the Technical Operations organization in BioMarin’s evolution—growing from a start-up with one groundbreaking rare disease therapy to a world leader in transforming lives through genetic discovery.Download Now ⌃
We maximize the impact of genetic innovation to develop transformative therapies.
Each drug candidate we pursue is guided by a fundamental understanding of the genetics and underlying biology of the condition it will address.View Now Our Pipeline ⌃
Our management team represents a dynamic cross section of business, clinical and biotechnical expertise.Learn More about our leadership team ⌃
More than twenty years of transforming lives through genetic discovery.Learn More about our history ⌃