Over $1 billion is to be invested in new biologics production in the US and Europe

Last week was a good one for construction engineers tracking the biopharma industry. Three significant new capital investments were announced; notably, all three involve biologics, giving more evidence (in case anyone needed it) that the industry is shifting more and more into biotech products.

• Roche Group, parent of Genentech, announced a $285-million expansion of its manufacturing facilities in Vacaville and Oceanside, CA. The company says that when complete, the Vacaville facility will not only be the largest producer of biologic medicines for the Roche Group but also the largest biotech manufacturing facility in the world. It also notes that the expansion will create 250 permanent new jobs—which works out to over $1 million per manufacturing job created. Roche is investing another $600 million in projects in Basel, Switzerland and Penzberg, Germany.
• In Framingham, MA, Genzyme has announced an $80-million expansion of its manufacture of Fabrazyme (agalsidase beta); the company’s news release says that the expansion is for downstream processing of its newly approved cell culturing site in Framingham, and that final fill-finish will continue at another facility in Waterford, Ireland. This announcement comes with a lot of baggage; Genzyme had run into production problems in 2009 with Farbrazyme, leading eventually to a $175-million fine from FDA, and to complications with its acquisition (since completed) by sanofi-aventis. Along the way, Genzyme was keeping its eye on Shire Pharmaceutical, which markets Replagal (agalsidase alpha) outside the US; FDA denied its approval in 2012, but had earlier recommended its use for Fabry’s disease patients who had no alternative during the Fabrazyme production hiatus.
• Vetter Pharma International (Ravensburg, Germany), the contract development and manufacturing organization, is spending $100 million to expand vial- and syringe-filling capacity in Ravensburg and Chicago (which handles clinical syringe-filling). The company is also adding refrigerated and room-temperature storage, and lyophilization machines.