Evaluating the Pieces in Big Pharma's Manufacturing Investments - Pharmaceutical Technology

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Evaluating the Pieces in Big Pharma's Manufacturing Investments
The pharmaceutical majors target biologics and emerging markets in their manufacturing expansion activities and plans.


Pharmaceutical Technology
Volume 37, Issue 8, pp. 38-41


Table I: Top 50 pharmaceutical companies (Rankings 1-25)
Novartis. In the fourth quarter of 2012, Novartis announced plans to construct a new biotechnology production site in Singapore with an investment valued at more than $500 million. The new facility will focus on drug- substance manufacturing based on cell-culture technology. Construction begins in 2013, and the site is expected to be fully operational in 2016. It will be colocated with the company’s pharmaceutical production site in Tuas, Singapore. In the future, Novartis expects its Singapore site to be a technological competence center for both biotechnology and pharmaceutical manufacturing.

In December 2012, Novartis acquired a 16,000-m2 FDA-approved manufacturing facility in Morris Plains, New Jersey from the biopharmaceutical company Dendreon for $43 million. The facility and certain former Dendreon personnel that were retained will support clinical and commercial production of products from the Novartis-University of Pennsylvania (Penn) collaboration announced in August 2012. Under the Novartis-Penn pact, the parties will research, develop, and commercialize targeted chimeric antigen receptor immunotherapies as well as build on the Penn campus in Philadelphia the Center for Advanced Cellular Therapies, which will be dedicated to developing and manufacturing adoptive T-cell immunotherapies.

On the vaccine side, Novartis is proceeding with a multiyear vaccine-production project. In 2008, it broke ground on a new rabies and tick-borne encephalitis $330-million manufacturing facility in Marburg, Germany. Construction is complete, and the facility is in the process of executing the necessary validation activities with regulatory approvals for products planned for 2013. In 2009, Novartis opened a new cell culture-based influenza vaccine-manufacturing site in Holly Springs, North Carolina. As of Dec. 31, 2012, the total amount spent on the project was $426 million, net of grants reimbursed by the US government. The total investment in this new facility is expected to be at least $900 million, partly supported by grants from the US government and prior investments in influenza cell-culture technologies at the Novartis vaccines site in Marburg, Germany. Novartis is also building a new $475-million vaccine-manufacturing facility in Recife, Brazil. The technical start-up of the facility is planned for approximately 2015.

Novartis is moving forward with other investments. The current phase of the long-term redevelopment of its St. Johann headquarters site in Basel, Switzerland is expected to be finalized in 2015. This project was started in 2001 with the aim of transforming the site from one designed mainly for pharmaceutical production into a center of knowledge with an emphasis on international corporate functions and research activities. Novartis expects that through 2015 it will spend more than $2.3 billion on the project and will transfer production from the site to other facilities in the Basel region.

In the second quarter of 2012, Novartis began construction of a new CHF 500 million ($535 million) solid-dosage manufacturing facility in Stein, Switzerland. The new facility will replace an older facility that will be partially demolished by 2016. Stein is planned to be a technological competence center for sterile and solid dosage drugs. During 2012, Novartis also began a series of projects in which the company expects to invest over $300 million during the next several years in the following three areas: implementation of a serialization product-tracking program across its pharmaceutical operations network, a GMP upgrade for its milling and blending center at Stein, and an upgrade of change-control systems. The company also is continuing a multiyear upgrade of its campus in East Hanover, New Jersey. The company expects that through 2013, it have spent more than $545 million to complete the construction and consolidate operations there.

In emerging markets, Novartis is investing $140 million for a new pharmaceutical plant in St. Petersburg, Russia. Annual production is expected to be 1.5 billion units per year (oral solid dosage forms), of which the majority will be for generic-drug products. Product registration for production at the site is expected to begin in 2014.

In China, Novartis is moving ahead with an expansion of its research facilities. In 2009, Novartis announced it was investing $1 billion to increase its R&D operations in Shanghai. Based on a re-evaluation of the site conducted in 2010, the company expanded its Phase 1 plan to include two buildings to house 800 offices and 400 laboratory work places. As of Dec. 31, 2012, structural work was finished, and the first above-ground buildings began to be built. Novartis also began construction in April 2012 for new laboratory and office space at its research facilities in Cambridge, Massachusetts as part of a multiyear $600-million investment at that site.


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