Big Pharma: Biomanufacturing Investments Lead the Way

Biomanufacturing is a leading area of investment for the pharmaceutical majors. So what are the leading projects announced, underway, or recently completed? DCAT Value Chain Insights (VCI) examines key projects.

With recent large investments by Bristol-Myers Squibb, AstraZeneca, and Boehringer Ingelheim to name a few, biomanufacturing expansions are on an upward trajectory. A look inside the major projects and what is on the horizon.

BMS, BI, AstraZeneca, and Shire lead the way
Bristol-Myers Squibb. Bristol-Myers Squibb is proceeding with another large-scale biomanufacturing project, this time in Ireland following the company’s $750-million investment for a new biologics bulk manufacturing facility in Devens, Massachusetts. Bristol-Myers Squibb’s plans to open a new EUR 900 million ($1.02 billion) large-scale biologics manufacturing facility in Cruiserath, County Dublin, near Blanchardstown that will produce multiple therapies for the company’s growing immuno-oncology portfolio. The manufacturing facility is estimated to be operational in 2019.

In 2016, Bristol-Myers Squibb completed a major expansion at its Devens facility. The $280-million project added two new buildings to the 89-acre Devens campus: a biologics development building for designing processes for the early production of investigational medicines, and a clinical manufacturing building where investigational medicines will be produced to support clinical trials. Both are new capabilities for Devens, a site that had previously focused solely on large-scale, bulk biologics manufacturing. The two new buildings also add approximately 200,000 square feet to a site now comprised of eight major buildings in a 600,000-square-foot complex. When combined with the company’s initial $750 million investment to build the facility, the expansion project brings the company’s total investment at the site to more than $1 billion.

Boehringer Ingelheim. In December 2015, Boehringer Ingelheim announced an approximate EUR 500 million ($568 million) investment for a new large-scale biopharmaceutical production facility for active ingredients manufactured using cell cultures at its site in Vienna, Austria. In Vienna, Boehringer Ingelheim has up to now produced active ingredients using microorganisms; over the next few years, cell-culture technology will also be transferred there. The new production plant is scheduled be operational by 2021. The company already has two large-scale facilities in Biberach, Germany used for market launch and cell-culture-based manufacture of biopharmaceuticals. Biberach will remain Boehringer Ingelheim’s largest European cell culture and global launch site for biopharmaceutical products.

In July 2017, Boehringer Ingelheim announced a $217-million investment to upgrade and expand its Fremont, California biomanufacturing facility. This expansion will enable the company to increase its manufacturing capacity by one-third. The facility is part of the company’s biomanufacturing network, which also includes sites in Biberach, Germany and Vienna, Austria. Earlier in 2017, the company inaugurated a commercial production site for biopharmaceuticals in Zhang Jiang Hi-tech Park in Shanghai, China. The site, with first-phase investment of more than EUR 70 million ($78 million), uses mammalian cell-culture technology and will support the company’s contract manufacturing business. The facility will operate for clinical and commercial supply on a 2000-L single-use bioreactor scale. It is designed to flexibly add additional 2000-L single-use bioreactors and fill/finish capabilities.

Merck & Co. Earlier in 2017, Merck & Co. announced plans to invest EUR 280 million ($313 million) over the next three years at two of its Irish manufacturing sites in Carlow and Cork Counties, Ireland. The company’s site in Brinny, County Cork is an integrated site for the development, testing, and manufacturing of biologics, specializing in the fermentation, purification, and sterile filling of biologics. The Carlow site is a facility that formulates and fills vaccines and biologics.

AstraZeneca. In November 2014, AstraZeneca announced plans to expand its biologics manufacturing center in Frederick, Maryland. The more than $200-million project will increase production capacity at the facility to support AstraZeneca’s maturing pipeline and to meet future demand for its biologics portfolio. AstraZeneca’s Frederick biologics manufacturing center is a US Food and Drug Administration (FDA) licensed, large-scale cell-culture production facility with administrative, production, warehouse, laboratory and utility space. The expansion project is expected to be completed in 2017 and will add approximately 40,000 additional square feet of manufacturing, laboratory, and administrative space. AstraZeneca’s Frederick manufacturing center is the largest biologics manufacturing facility within the company’s global network and portfolio of assets and provides cell- culture manufacturing.

Shire. Shire announced in 2016 that it plans to expand its global biotechnology manufacturing capacity over the next four years by investing $400 million in Ireland. The company will create a biologics manufacturing campus on a 120-acre site at Piercetown, County Meath. The site is expected to be operational by mid-2019.

Shire’s legacy manufacturing facilities are in Cambridge and Lexington, Massachusetts. The Cambridge site also includes warehouse facilities. The Lexington site also includes laboratories, warehousing, and distribution operations. The company also has a warehousing and distribution facility in Florence, Kentucky, a warehousing facility in North Reading, Massachusetts, and laboratory and office space in Sao Paulo, Brazil.

Shire added to its manufacturing network with its $32-billion acquisition of Baxalta, which was completed in 2016. Baxalta’s global headquarters are located in a 260,000-square-foot facility in Bannockburn, Illinois, and the company manufactures its products in more than 10 manufacturing facilities. Baxalta is expanding its manufacturing facility in Krems, Austria, for production of hematology products. The expansion project is expected to be completed in 2018. The company is also building a manufacturing facility near Covington, Georgia, to support the growth of its plasma-based products. The timeline on the project spans several years with commercial production scheduled to begin in 2018.

Other investments
AbbVie. In 2014, AbbVie announced a $320-million investment to establish operations in Singapore for small-molecule and biologics active drug substance manufacturing. The completed facility will provide manufacturing capacity for emerging compounds within AbbVie’s oncology and immunology pipeline to serve markets globally. The investment establishes the first manufacturing presence in Asia for AbbVie. AbbVie anticipates the new facility will be fully operational by 2019. Also, in 2014, AbbVie expanded its manufacturing facility in Sligo, Ireland.

Amgen. In November 2014, Amgen announced that it had completed construction of its $200-million biomanufacturing facility in Tuas Biomedical Park in Singapore to expand its manufacturing capability for monoclonal antibodies for both clinical and commercial products. Built in less than two years, the biomanufacturing facility was completed in half the time required for conventional biomanufacturing single-use plants. The company estimates that enhanced bulk production capabilities at the new plant, when compared to conventional alternatives, represents at one-quarter of the capital costs, one-third of the operating expense, and twice the speed to build the facility. The company estimates these new capabilities will result in an estimated cost reduction of 60% or more per gram of protein. Amgen also announced it will build another facility at its Tuas, Singapore site that will make carfilzomib, the small-molecule active ingredient for Kyprolis, an anti-cancer drug.

Eli Lilly and Company. Earlier this year in March 2017, Eli Lilly and Company announced plans to invest $850 million across its US operations in 2017, including research laboratories, manufacturing sites, and general and administrative areas. The investments are being driven by demand for Lilly products as well as its drug pipeline targeting cancer, pain, diabetes, and other unmet medical needs. The investments include plans for a new $85-million expansion of its Trulicity (dulaglutide) device assembly operations in the US, part of a five-year investment by the company to expand its US diabetes products manufacturing operations, which also includes a $140-million insulin cartridge production facility. Lilly’s $850-million total investment will fund both projects that are already underway as well as new projects that will be initiated throughout the course of the year, including additional projects in Indianapolis, Indiana.

GlaxoSmithKline (GSK). In July 2017, GlaxoSmithKline (GSK) decided not to proceed with a previously planned investment to build a new £350-million ($454 million) biopharmaceutical facility in Ulverston, UK, saying it no longer needs the additional capacity. GSK had announced the new biopharmaceutical facility in 2012, which at the time of the announcement, would have been the first new GSK manufacturing facility to be built in the UK in almost 40 years.

Earlier in 2017, GSK announced that it is investing $139 million in its biopharmaceutical manufacturing site in Rockville, Maryland to expand internal capacity for bulk drug substance production by close to 50%. The expansion will support demand for Benlysta (belimumab), GSK’s drug for treating active, autoantibody-positive, systemic lupus erythematosus (SLE). In addition to the bulk drug substance capacity expansion, the Rockville site is also expected to house production of a new subcutaneous form of belimumab, the active ingredient in Benlysta, which is currently under review with the US Food and Drug Administration. GSK gained the Rockville site, the former headquarters of Human Genome Sciences (HGS), when it acquired HGS in 2012 for $3.6 billion.

Earlier this year in 2017, GSK began construction on a new meningococcal B vaccine manufacturing plant in Marburg, Germany, in which the company is investing EUR 162 million ($172 million). GSK broke ground on the new site in March 2017.

Novartis. Novartis is proceeding with a major biomanufacturing investment. In 2012, the company announced the construction of a new biotechnology production site in Singapore with a planned investment of more than $700 million. The new facility will focus on drug-substance manufacturing based on cell-culture technology. Ground was broken in February 2013. The company expects Phase One of this project to be operational in 2017 and Phase Two in 2019. It will be co-located with the company’s pharmaceutical production site based in Tuas, Singapore. In the future, Singapore is expected to be a technological competence center for both biotechnology and pharmaceutical manufacturing at Novartis. Through December 31, 2016, the total amount paid on this project was $546 million.

Roche. Over the past several years, Roche has announced investments of more than CHF 2 billion ($2.1 billion) in its biologics manufacturing capacity. Roche made and is proceeding with several expansions across sites in Penzberg (Germany), Basel (Switzerland) as well as Vacaville and Oceanside (California). At its manufacturing site in Penzberg, Germany, Roche is expanding its biologics capabilities and is investing a total of CHF 400 million ($417 million). This expansion project will be operational in 2018. In Basel, Switzerland, Roche has begun the construction of a production center for antibody drug conjugates (ADCs). The new ADC facility will support the manufacturing of Kadcyla, the company’s ADC for the treatment of breast cancer, as well as future ADCs. This new center will cost approximately CHF 190 million ($198 million) and was planned to be operational in 2016.

Sanofi. In 2014, Sanofi launched a platform dedicated to biologics to develop synergies between Pharmaceuticals, Sanofi Pasteur, Sanofi Genzyme and the company’s Biotherapeutics activities. Three dedicated biotechnology sites have been developed: Paris/Lyon (France), Frankfurt (Germany) and Boston (United States). In January 2015, Sanofi entered into a strategic agreement with Boehringer Ingelheim for the manufacture of therapeutic monoclonal antibodies to reinforce Sanofi’s manufacturing capacity to support upcoming product launches. Sanofi said that 72% of its research and development projects are in biologics, nearly half of which are monoclonal antibodies. Boehringer Ingelheim’s cell-culture operations will provide contract manufacturing capacities to support the production of Sanofi’s biologics pipeline. Under the agreement, Sanofi will have access to Boehringer Ingelheim’s capabilities in Biberach an der Riss, Germany to transfer and manufacture therapeutic monoclonal antibodies for global market supply.

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