Big Pharma's Manufacturing Blueprint for the Future - Pharmaceutical Technology

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Big Pharma's Manufacturing Blueprint for the Future
The pharmaceutical majors continue rationalizing manufacturing capacity in established markets as they forge their manufacturing networks in biologics and emerging markets.

Pharmaceutical Technology
Volume 35, Issue 8, pp. 40-47

Sanofi. In 2010, Sanofi invested nearly EUR 1.2 billion ($1.72 billion) to increase capacity and improve productivity at various production and R&D sites, according to the company's 2010 SEC annual filing. In Europe, the company invested in two new production lines at its facility in Frankfurt for Lantus (insulin glargine). The company also invested in its Brindisi, Italy, site to expand production of spiramycin, the active ingredient of the antibiotic Rovamycin. In the US, the company is investing in epiCard, a gas-powered single dose, single-use autoinjector with audible user instructions for injecting of epinephrine, which is indicated for treating severe allergic reactions.

In France, Sanofi is proceeding with its Biolaunch project, which is designed to convert its chemical production facilities to biotechnology-based ones. The project includes a plan for a production facility for monoclonal antibodies at its site in Vitry-sur-Seine, which is expected to be completed by 2012, plus further investments to create a new biosynthetic process at its sites in Elbeuf and Vertolaye to improve corticosteroid production competitiveness.

Sanofi has several projects in emerging markets. In China, the company is expanding its manufacturing facility in Beijing by installing assembly and packaging lines for SoloStar, a prefilled injection pen used to administer the company's Lantus insulin product. In Hangzhou, China, Sanofi is building a new manufacturing site, scheduled to be completed in 2012, to replace an existing manufacturing facility there. In Russia, Sanofi is increasing insulin capacity at its facility in Orel; the company obtained the facility following its acquisition of a controlling stake in the pharmaceutical company Bioton Vostok in 2010. In Latin America, Sanofi is expanding its vaccine-manufacturing operations in Mirador, Argentina.

Sanofi has made several acquisitions to increase its presence in emerging markets. The company gained industrial sites from its 2009 acquisitions of generic-drug companies Zentiva in Eastern Europe and Medley in Brazil. In August 2010, sanofi also acquired Nepentes, a Polish manufacturer of pharmaceuticals and dermocosmetics. In October 2010, Sanofi acquired a 60% equity interest in the Chinese consumer-healthcare company Hangzhou Sanofi Minsheng Consumer Healthcare in partnership with Minsheng Pharmaceutical. Sanofi also acquired the Chinese specialty pharmaceutical company BMP Sunstone earlier this year.

In its vaccines business, Sanofi has made several key investments during the past several years: the construction of a research facility in Toronto, Canada; the creation of a new vaccines campus in Neuville, France; the construction of bulk and filling facilities in Val de Reuil, France, and the establishment of a bacteriological bulk facility in Marcy l'étoile, France; the creation of two new influenza vaccine facilities in Shenzhen, China, and Ocoyoacac, Mexico; and the completion of bulk and filling facilities, mainly dedicated to influenza and meningitis vaccines, in Swiftwater, Pennsylvania.

In April 2011, Sanofi completed its $20.1-billion acquisition of the biopharmaceutical company Genzyme and gained several manufacturing facilities. In its 2010 SEC annual filing, Genzyme reported on the construction of a new manufacturing facility in Framingham, Massachusetts, which is to include four bioreactors for producing Cerezyme (miglucerase) and Fabrazyme (agalsidase beta), which had been manufactured at the company's facility in Allston Landing, Massachusetts. According to Genzyme's annual filing, it expects to receive US approval for the Framingham facility in the second half of 2011. Genyzme had transferred production of certain products following manufacturing problems at the Allston facility and a subsequent FDA consent decree.

In 2010, Genzyme transferred its fill–finish operations for Fabrazyme and Myozyme (alglucosidase alfa), 160-L, sold in the US from the Allston facility to a contract manufacturer and to Genzyme's Waterford, Ireland, facility. Genzyme is expanding its fill-finish capacity by 400% at the Waterford facility, where Cerezyme, Lumizyme (alglucosidase alfa), and Myozyme (alglucosidase alfa) are filled–finished. It expects to receive product-specific approval for this additional capacity beginning in late 2011.

The company manufactures Lumizyme and Myozyme at the 4000-L bioreactor scale at a facility in Geel, Belgium. In its annual filing, Genzyme reported that it is adding a third 4000-L liter bioreactor at the facility and expects to receive approval of the additional capacity by the end of 2011. In addition, Genzyme began construction of an additional manufacturing facility in Geel, which will include two 4000-L bioreactors for Lumizyme and Myozyme production and expects to receive approval for this new facility in late 2014.


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