Sanofi's subsidiary Genzyme began production of the enzyme-replacement therapy Fabrazyme (agalsidase beta) at its new facility
in Framingham, Massachusetts, following approval of the facility by FDA and EMA in January 2012. In May 2012, EMA and FDA
approved a second operation for fill–finish at Genyzme's Waterford, Ireland, manufacturing plant, which nearly doubled capacity
for fill–finish for Myozyme and Lumizyme (alglucosidase alfa) at the 4000-L scale. These developments follow a 2010 consent
decree issued by FDA to Genzyme for manufacturing violations at its Allston, Massachusetts, facility and resulting requirements
to transfer fill–finish production out of that facility. Other investments by Genzyme include expansion of Myozyme production
capacity in Geel, Belgium, Fabrazyme in Framingham, Massachusetts, Thymoglobulin (anti-thymocyte globulin (rabbit)) in Lyon,
France, and the filling operations in Waterford, Ireland.
Other recent investments by Sanofi are in two new Lantus production lines in Frankfurt, which complemented an earlier acquisition
of the Diabel manufacturing site from Pfizer, to expand insulin production. Sanofi invested in its Brindisi, Italy, site to
expand production of spiramycin, the API in the antibiotic Rovamcyin. The company also is investing in the launch of epiCard,
a gas-powdered single-dose, single-use, auto-injector for epinephrine.
Sanofi is continuing with its Biolaunch project, which is designed to converts its chemical facilities to biotechnology-based
production. It is on track to create a monoclonal antibody production facility at its site in Vitry-sur-Seine, France, and
is investing in new biosynthetic processes as its sites in Saint-Aubin-Les Elbeuf and Vertaolaye, France. In May 2009, Sanofi
began construction of a new EUR 300 million ($364 million) manufacturing center in Neuville-dur Saône, with the the goal to
progressively transition existing chemical production to vaccine production beginning in 2013. Sanofi Pasteur, the vaccine
arm of Sanofi, is scheduled to begin commercial production of a new antigen production unit in Mexico for seasonal and pandemic
influenza vaccines in 2012, once the necessary production and marketing approvals have been obtained from Mexican regulatory
In emerging markets, in May 2012, Sanofi inaugurated a new assembling and packaging line for producing its prefilled insulin
injection pen Lantus SoloStar at its facility in Beijing. The company announced a second phase $90-million project to install
a cartridge aseptic product line at the facility. The facility has a designed capacity of 48 million units. Sanofi is building
a new manufacturing site in Hangzhou, China, to replace an existing manufacturing site there, which is scheduled to be completed
in 2012. The company reached an agreement with the King Abdulah Economic City to build a manufacturing facility for solid-dosage
forms in Saudi Arabia.
In 2011, Roche executed 25 major engineering projects. Key projects included transforming its manufacturing facility for
solid dosage forms in Shanghai from a local to a global supply operation. In early 2011, the facility received FDA and EMA
approvals to produce Xeloda (capecitabine) for the US and EU markets.
In June 2011, Roche completed a CHF 191-million ($193 million) expansion at it facility in Penzberg, Germany, which upgraded
and expanded the site's therapeutic protein development and production capacity. In November 2011, Roche completed construction
of a new CHF 250 million ($252 million) technical R&D facility in Basel, Swizterland. The facility houses laboratories, offices,
and small-scale production lines. In late 2010, Roche divested technical development and small-molecule manufacturing operations
in Boulder, Colorado, to Corden Pharma. Corden will continue to supply Roche with commercial-scale peptides and chemical APIs.
Roche also sold its clinical plant in Oceanside, California to Gilead Sciences.