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CMOs have been active over the past year in expanding their biologics production and capabilities.
From boosting cell-culture capability to growing bioreactor capacity, contract manufacturing organizations (CMOs) have been making investments to expand biologic output. Pharmaceutical Technology highlights some of the major biologics-based CMO activity in the past months.
In March 2018, Fujifilm acquired Irvine Scientific Sales Company and IS Japan, both cell-culture media companies, in a stock purchase agreement valued at around $800 million. The acquisition expanded Fujifilm’s biopharmaceuticals product portfolio to include in-vitro fertilization and cell therapy. The company stated that the acquisitions will expand its biopharmaceuticals contract development and manufacturing business and accelerate regenerative-medicine R&D as well as expand its reagent business. The company also plans to establish a new site in Boston, MA, by March 2019 for marketing products and services that support R&D and new-drug manufacturing (1).
In November 2017, Celonic, a biologics development and manufacturing services provider, acquired a biomanufacturing facility in Heidelberg, Germany, from Glycotope, a clinical-stage immune-oncology company. With the acquisition, Celonic expands its GMP manufacturing assets, including continuous perfusion manufacturing, which the company now offers in addition to fed-batch manufacturing and the ability to scale-up from pilot to commercial-scale production. Combining Glycotope’s GlycoExpress human cell-line platform with Celonic’s CHOvolution integrated development platform will create custom-tailored expression systems (2).
In October 2017, Lonza Pharm & Biotech acquired a clinical-stage mammalian manufacturing facility in Hayward, CA, from Shire. The 58,000-ft2 site includes 1000-L and 2000-L single-use bioreactors and associated downstream capabilities and provides added cGMP capacity to supplement existing assets in Lonza’s Slough, Berkshire, United Kingdom site (3).
Lonza plans to add mid-scale mammalian capacity at its facility in Portsmouth, NH, with the installation of multiple 6000-L bioreactors, the company announced in May 2018. Construction is expected to start in late 2018. The company will also include the addition of multiple cell-therapy suites as part of the expansion. The hybrid facility will house full-suite process analytic technology, multi-variate analysis, and single-use technologies in an existing building and is expected to be operational by late 2018 (4).
Patheon, now a part of Thermo Fisher Scientific, is expanding its biologic drug substance manufacturing capabilities with a $50-million investment by Thermo Fisher into the Patheon Biologics Center of Excellence (COE) for Biological Commercial Manufacturing in St. Louis, MO. The site provides process development, clinical cGMP manufacturing, and commercial manufacturing using fed batch and perfusion processes. The investment, announced in April 2018, includes a 64,000-ft2 expansion to the existing manufacturing building #2 at the site and will feature Thermo Fisher bioproduction bioreactors, consumables, and factory automation. The expansion will double the site’s manufacturing capacity. The expanded site is expected to be operational in 2019 (5).
WuXi Biologics, part of WuXi AppTech, announced a couple of expansion plans in recent months. In April 2018, the company said it plans to invest €325 million (US$381 million) in a new biomanufacturing facility in Mullagharlin, Dundalk, County Louth, Ireland. This new facility will use multiple single-use bioreactors for commercial biomanufacturing and is designed to be able to run continuous bioprocessing. The company intends to install a total of 48,000 L fed-batch and 6,000 L perfusion bioreactor capacity (6).
Prior to that, in March 2018, the company announced that it would install 4000-L custom single run (CSR) disposable bioreactors from ABEC, a provider of integrated process solutions and biopharmaceutical manufacturing services, at its new 30,000-L commercial manufacturing facility in Wuxi City, Jiangsu, China. The 4000-L CSRs will enable scale-up of manufacturing up to 24,000 L (7). The new 500,000-ft2 Wuxi City facility, in which the company invested $150 million, became fully operational in December 2017. It quintuples the company’s existing manufacturing capability and will support the biologics commercial manufacturing pipeline coming from global partners. Following completion of the first phase of construction in September 2016, the facility offers two 1000-Ldisposable bioreactors for perfusion processes, making it the largest perfusion biomanufacturing facility using disposable bioreactors in Asia, as reported by WuXi Biologics. The facility was later equipped with an additional 14 2000-L disposable bioreactors for fed-batch cell culture (8).
AGC Biologics, a contract development and manufacturing organization (CDMO), is adding a 2000-L single-use bioreactor to its Berkeley, CA, facility and plans to build a new complex that will house the company’s headquarters in Bothell, WA. The bioreactor addition at its Berkeley facility will support the company’s growing biologics capacity, which has tripled over the past three years. The Berkeley facility uses both single-use and stainless-steel bioreactors for cell-culture manufacturing in scales of 100–3000 L (9). The new 15,000-ft2 complex to be built at Bothell will provide expansion space for additional manufacturing capacity as well as in-house process development labs and corporate administrative offices. The Bothell expansion will also include a new R&D center dedicated to novel therapeutic protein manufacturing technologies (10). The company announced both these investments in March 2018.
CMO Emergent BioSolutions is equipping its bulk manufacturing facility in Bayview, Baltimore, MD, with a 4000-L custom single run (CSR) bioreactor supplied by ABEC, a provider of engineering, equipment, and services to the biopharmaceutical manufacturing sector. The company announced the addition in October 2017. The 4000-L bioreactor, designed specifically for Emergent’s process needs, operational requirements, and facility constraints, will expand cell-culture capacity at the Bayview site and is expected to improve process transfer and scale-up, according to ABEC (11).
1. Fujifilm, “Fujifilm to Acquire Irvine Scientific Sales Company and IS Japan, Leading Companies of Cell Culture Media,” Press Release, March 29, 2018.
2. Celonic, “Celonic Acquires Glycotope’s Bio-manufacturing Facility,” Press Release, Nov. 3, 2017.
3. Lonza, “Lonza to Acquire a US Clinical Manufacturing Site to Support Ongoing Customer Demand,” Press Release, Oct. 3, 2017.
4. Lonza, “Lonza to Invest in Portsmouth, NH (USA) Site, Including Mid-Scale Biologics,” Press Release, May 4, 2018.
5. Thermo Fisher Scientific, “Thermo Fisher Scientific Announces $50-Million Investment to Enhance Biologics Capabilities,” Press Release, April 23, 2018.
6. WuXi Biologics, “WuXi Biologics to Invest €325-Million to Build Largest Biomanufacturing Facility Using Single-Use Bioreactors in Ireland,” Press Release, April 30, 2018.
7. WuXi Biologics, “WuXi Biologics to Install Industry’s Largest Single-Use Bioreactor from ABEC at its New Commercial Manufacturing Facility,” Press Release, March 20, 2018.
8. WuXi Biologics, “WuXi Biologics Initiated cGMP Manufacturing in the World’s Largest Biologics Manufacturing Facility Using Only Single-Use Bioreactors,” Press Release, Dec. 6, 2017.
9. AGC Biologics, “AGC Biologics Expands Capacity at Berkeley, California Facility,” Press Release, March 6, 2018.
10. AGC Biologics, “AGC Biologics Increases Footprint in Bothell, WA,” Press Release, March 29, 2018.
11. ABEC, “ABEC 4,000-Liter Single-Use Bioreactor to Expand Emergent BioSolutions Manufacturing Capability,” Press Release, Oct. 24, 2017.
Pharmaceutical Technology Supplement: Outsourcing Resources
When referring to this article, please cite it as F.Mirasol, " CMO Roundup: Expansions for Biomanufacturing," Pharmaceutical Technology Outsourcing Resources Supplement (August, 2018).