Big Pharma's Manufacturing Investments in Biologics - Pharmaceutical Technology

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Big Pharma's Manufacturing Investments in Biologics
Despite overall manufacturing rationalization in the pharmaceutical/biopharmaceutical industry, the large pharmaceutical companies continue to invest in biologic-based manufacturing.

Pharmaceutical Technology
Volume 37, Issue 5, pp. s8-s11

Sanofi. As part of its growth strategy in diabetes, Sanofi’s Frankfurt, Germany site, its principal manufacturing center for Sanofi diabetes products, is being equipped with a new aseptic processing area that uses isolator technology to significantly improve the aseptic-filling process. This investment will be operational in 2016. The Sanofi diabetes industrial network also is expanding its manufacturing footprint in emerging markets, both in Russia and in China (Beijing), where a new facility that was inaugurated in 2012 has begun assembly and packaging of SoloSTAR, the prefilled injection system for Lantus (insulin glargine). Also, during 2012, Sanofi’s Ankleshwar Pharma site in Gujarat State, India, handled packaging and quality control through to release the first commercial batches of AllSTAR, the company’s insulin pen specifically intended for the India market.

Its Frankfurt site is one of three dedicated biotechnology hubs that Sanofi is developing in Europe. In 2012, its facility in Vitry-sur-Seine, its biggest integrated cell-culture facility, produced the first technical batches of aflibercept, the API in the company’s anticancer drug Zaltrap. Its facility in Lyon Gerland, France, is a new world center dedicated to the production of thymoglobulin, a drug to prevent and treat transplant rejection. During 2012, teams at Lyon prepared a dossier for the healthcare authorities as part of the process of transferring production to this site.

In the United States, Sanofi, through its subsidiary Genzyme, has major investments underway, including at its Framingham, Massachusetts biologics site, which was approved by FDA and EMA in 2012 for the manufacture of Fabrazyme (agalsidase beta) to treat Fabry disease. Its site at Allston, Massachusetts has initiated a major investment program in connection with the implementation of its compliance-remediation workplan, approved by FDA in January 2012. In 2012, Sanofi’s Genzyme acquired the Bayer Healthcare facility in Lynnwood, Washington, which specializes in the manufacture of Leukine (sargramostim).

On the vaccine side, Sanofi Pasteur, the company’s vaccine arm, is undergoing a major investment phase, which includes a new dedicated dengue fever vaccine facility in Neuville, France, which is scheduled to produce its first batches in 2014. Two new, dedicated influenza vaccine-manufacturing facilities are in the start-up phase. Sanofi’s facility in Shenzhen, China is currently testing its production processes, and its facility in Ocoyoacac, Mexico was approved by Mexican regulatory authorities at the start of 2012 and began production in time for the Mexican influenza vaccination program in September 2012. In response to observations made by FDA during routine inspections conducted in 2012 at its facility in Toronto and Marcy l’Etoile, France, Sanofi Pasteur initiated a compliance program to addres quality issues that had been identified.

Roche. Roche is investing CHF 240 million ($257 million) at its facility in Penzberg, Germany to expand raw-material manufacturing for its Elecsy immunoassays, to be completed by the end of 2014, as well as to increase compounding, filling, and lyophilization capacity, which is planned for 2016. At its sites in Basel and Kaiseraugst, Switzerland Roche is investing approximately CHF 230 million ($246 million). Three projects were completed in 2012: a new pharmaceutical quality control and assurance building, expansion of cold-chain storage capacity, and a filling line upgrade for Herceptin (trastuzumab) subcutaneous formulation. The company is also expanding capacity to increase capacity for high-potency drugs.

GlaxoSmithKline. GlaxoSmithKline (GSK) announced plans to invest more than 500 million ($798 million) in the UK across its manufacturing sites, which included selecting Ulverston in Cumbria as the location for the first new GSK manufacturing facility to be built in the UK in almost 40 years. The company also will invest in sites in Montrose and Irvine, Scotland. GSK’s announcement followed plans by the UK government to implement a “patent box” to encourage investment in R&D and related manufacturing in the UK by introducing a lower rate of corporation tax on profits generated from UK-owned intellectual property. Following a feasibility study conducted through 2011, GSK said it will locate a new 350 million ($559 million) biopharmaceutical manufacturing facility in Ulverston, Cumbria. Detailed planning and design of the new facility is underway with an anticipated start date for construction of 2014–2015, dependent on portfolio timing and obtaining necessary planning and related consents. Once construction starts, it is likely to take at least six years before the plant is fully operational.

Eli Lilly. In 2012, Eli Lilly reported that it is investing EUR 330 million ($430 million) in a new biopharmaceuticals facility at its Kinsale campus in Cork, Ireland.


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