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Patricia Van Arnum was executive editor of Pharmaceutical Technology.
Roche's plans for a major biologics manufacturing expansion is the latest investment by Big Pharma
As pharmaceutical companies intensify their product development and commercialization of biologic-based drugs, they are also investing in biologics manufacturing capacity. Roche and Sanofi are the latest companies to announce investments in biologics.
Roche plans to invest CHF 800 million ($879 million) within its global manufacturing network to increase production capabilities for its biologic medicines over the next five years. The investment will be spread across sites in the following locations: Penzberg, Germany; Basel, Switzerland; and Vacaville and Oceanside, California in the United States. The investment will support increasing demand for Roche's licensed biologic medicines, such as RoACTEMRA (tocilizumab), Kadcyla (trastuzumab emtansine), and Perjeta (pertuzumab) as well as provide a manufacturing foundation for 39 investigational biologic medicines in the Roche pipeline.
Biologic manufacturing capacity will be increased at sites in Vacaville and Oceanside with a planned investment of approximately CHF 260 million ($285.6 million). In Penzberg, Roche will invest approximately CHF 350 million ($384 million) toward increased manufacturing capacity and equipment refurbishment. In addition, Roche will construct an antibody-drug conjugate (ADC) production facility in Basel, Switzerland through an investment of more than CHF 190 million ($209 million), which is expected to create 50 jobs. This investment will provide additional capacity and flexibility to support Roche’s first approved ADC, Kadcyla, and a further eight ADCs in clinical development.
Genzyme, a Sanofi company, will invest $80 million to build a new downstream processing facility for Fabrazyme (agalsidase beta) to support anticipated growth in global demand over the coming years. The new plant, which will be located adjacent to the new Fabrazyme cell-culture manufacturing site in Framingham, Massachusetts, will expand purification capacity.
Pfizer is investing $130 million in two of its Irish manufacturing sites: $100 million at its Grange Castle site in Dublin and $30 million in the Ringaskiddy site in Cork, according to a July 11, 2013 press release from IDA Ireland, Ireland’s industrial development agency. The $100-million investment in Grange Castle is for additional mammalian-cell manufacturing capacity with the addition of a new production line, scheduled to be operational in 2015, when the first process validation batches will be made. In 2011, Pfizer invested $200 million in the Grange Castle site to develop a new suite to expand the manufacturing process for an invasive pneumococcal vaccine, according to IDA.
Bristol-Myers Squibb is spending 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. 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 was the company’s largest single capital investment ($750 million) and provided the company 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: one 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.
Novartis is constructing 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. 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 2012, GlaxoSmithKline (GSK) announced it was investing more than £500 million ($767 million) in the United Kingdom 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. GSK will locate a new £350-million ($538 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, according to GSK.