Restructuring and manufacturing rationalization have been the order of the day for the large bio/pharmaceutical companies
during the past several years. Small-molecule and solid-dosage operations have been the largest target for such cost cutting,
but there are bright spots on the manufacturing investments. Several Big Pharma companies are investing in biologic drug-substance,
vaccine, and parenteral drug finished product manufacturing.
Alfred Pasieka/Getty Images; Dan Ward
Bristol-Myers Squibb. Bristol-Myers Squibb is investing approximately $250 million to expand its large-scale biologics manufacturing facility
in Devens, Massachusetts. The expansion will introduce biologics development and clinical-trial manufacturing capabilities
to the site while adding approximately 350 employees to the Devens workforce over time. The Devens site is home to the company’s
large-scale bulk biologic manufacturing facility. Construction of the Devens site was completed in 2009. It represented the
company’s largest single capital investment ($750 million) and provided Bristol-Myers Squibb with large-scale bulk biologics
production capacity. In May 2012, the company received FDA approval to manufacture its arthritis drug Orencia (abatacept)
at the Devens facility.
The new $250-million investment will be used to construct two new buildings on the 89-acre Devens campus: one building for
process development and one for clinical manufacturing. Together, the two buildings will add approximately 200,000 ft2 of laboratory and office space to the Devens site, which is now comprised of six major buildings in a 400,000-ft2 complex.
Work on the expansion is expected to begin in late 2013 and be completed in 2015. In the interim, Bristol-Myers Squibb has
leased 30,000 ft2 of laboratory space in nearby Hopkinton, Massachusetts, to begin moving some biologics process-development functions closer
to Devens during construction. The company intends to maintain this space until construction is completed.
Novartis. In the fourth quarter of 2012, Novartis announced the planned construction of 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 will begin 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.
Novartis purchased all fixed assets at the site, including all equipment, machinery, utilities, and cell- therapy-related
plant infrastructure. The land and building will continue to be leased from a third party. The facility, and certain former
Dendreon personnel that were retained will support clinical and commercial production of potential new products and therapies
that emerge from the Novartis–University of Pennsylvania (Penn) collaboration announced in August 2012. These drugs include
CTL019, a drug in Phase I/11 development for treating certain blood cancers. Under the Novartis–Penn pact, the parties will
research, develop, and commercialize targeted chimeric antigen receptor immunotherapies for the treatment of cancers 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.
Novartis also is proceeding with a multiyear vaccine-production project. In 2008, its Vaccines and Diagnostics Division 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.
The company is also proceeding with the building of a new $475-million vaccine-manufacturing facility in Recife, Brazil. The
manufacturing plant is part of Novartis vaccines’ strategy to enter the Brazilian market and is aligned with the government’s
goal to become self-sufficient in vaccines. The technical start-up of the facility is planned for approximately 2015.