BioMarin Pharmaceutical announced that the International Society for Pharmaceutical Engineering (ISPE) selected the company’s gene therapy manufacturing facility as the 2018 Facility of the Year Category Winner for Project Execution. 

The recognition highlighted the company’s successful construction of the facility in Novato, CA, which took less than a year to transform basic infrastructure into one of the first gene manufacturing facilities of its kind in the world. 

With the company’s hemophilia A investigational treatment valoctocogene roxaparvovec (formerly BMN 270) in global Phase 3 development and a need to produce material for the clinical studies and potentially for commercial demand, BioMarin converted an office and warehouse building into an 18,000 square foot gene therapy facility. The company proceeded with its project with the goal of releasing the first filled vials of Phase 3 clinical drug product in less than 15 months from project initiation. Beating the goal, the buildout and commissioning for the facility was accomplished in less than a year.

“The buildout of our gene therapy manufacturing facility was a logistical challenge that required leveraging our experience gained during licensure of our Galli and Shanbally biological facilities.   This plant provides us with scheduling flexibility allowing for rapid product development and is capable of providing sufficient capacity to meet clinical and projected commercial requirements,” said Robert Baffi, Ph.D., executive vice president of Technical Operations at BioMarin. “In addition, it creates the opportunity for our engineers and scientists to establish a valuable knowledge base required for manufacturing complex gene therapy products. This project demonstrated how the industry’s best people, equipped with the right technology and energized by the right motivation, can make a seemingly impossible project possible.”