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Bio/pharmaceutical contract service provides continue to invest in development, facility upgrades, technological advancement, and mergers and acquisitions.
Bio/pharmaceutical contract development and manufacturing organizations continued investments in technology and facility upgrades in 2016. The following are some of the latest developments.
Cambrex announced on July 12, 2016 the completion and validation of a $50-million production and warehousing expansion at its cGMP Charles City, Iowa site. The new 7500-sq.-ft. multi-purpose manufacturing facility will initially add a total of 70 cubic meters of glass-lined and Hastelloy reactors along with Hastelloy agitated filter dryers, and will be capable of handling potent APIs at an occupational exposure limit (OEL) of down to 1μg/m3. The 36,000-sq-ft cGMP warehouse provides general cGMP storage, and segregated 2-8 °C refrigerated storage with distributed control system monitoring and control for temperature and humidity (1).
Hovione has started expansion of its East Windsor, New Jersey facility, which will add 30,600 sq. ft. to the existing 24,000-sq.-ft. facility to handle potent drug substances. The expansion will include a new commercial spray dryer unit to complement the existing pilot unit. In addition, the facility will more than double its capacity to manufacture drug substance. The expansion is expected to add approximately 60 new jobs to the current workforce over the next three years. The start-up of the operation is expected to take place in April 2017 for the drug substance and spray drying services, and the continuous drug product manufacturing is expected to start up at the end of 2017 (2).
CordenPharma announced on July 2, 2016 that expansion of its Boulder, Colorado facility for the manufacture and development of oligonucleotide APIs will be completed by the end of 2016. The addition of oligonucleotide APIs will broaden the company’s service offerings, which currently include peptides, lipids, and carbohydrates for APIs and drug products (3). In late June, the Italian Medicines Agency approved Corden’s sterile injectable facility in Caponago, Italy. The recently completed manufacturing facility will support customer development and commercial programs by providing service in aseptic filling of liquid and lyophilized vials, and pre-filled syringes (4).
On July 5, 2016, Recipharm announced that the company will invest $19.7 million to expand blow-fill-seal (BFS) capacity at its site in Kaysersberg, France including the introduction of a BFS high-speed filling and packaging line. The company reports that it plans to add three additional filling lines to the facility in upcoming years, increasing the company’s BFS capacity by 50% (5).
On July 19, 2016, Quay Pharma announced that its laboratories and manufacturing facilities have completed FDA pre-qualification inspection that confirmed the company’s systems are GMP compliant, with no deficiencies identified. The company recently invested more than $3 million in GMP manufacturing suites to make larger batches of product for Phase 3 clinical trials and small-scale commercial manufacture for non-sterile products (6).
In early June 2016, FUJIFILM Diosynth Biotechnologies announced a planned collaboration with MSD, known as Merck in the United States and Canada, to invest in and operate a large-scale microbial-biologics facility for supply of API to its customers (7). The collaboration involves a $60-million investment by MSD at its Brinny manufacturing plant in Innishannon, County Cork, Ireland. Fujifilm Diosynth will lead customer interactions, program management, and process and analytical development. The MSD facility will operate as cGMP manufacturing support for FUJIFILM Diosynth’s contract development and manufacturing business. The 20,000-L facility will be operational in early 2018 for biotech and pharma customers of FUJIFILM Diosynth to address Phase III and commercialization needs.
In May 2016, FUJIFILM Diosynth Biotechnologies completed construction on a new three-story, 62,000-square-foot facility in Research Triangle Park, NC (8). The new building houses the company’s process and analytical research and development, process sciences, and stability groups. CMC Biologics announced in early June the completion of the first stage of the expansion of its manufacturing facility in Copenhagen, Denmark with the addition of a single-use Bioreactor 3PACK facility (9). The Bioreactor 3PACK configuration consists of three 2000-L single-use production bioreactors and associated seed train for scale up, which allows for production scales from 2000-L to 6000-L in a single production suite. The bioreactors can be run singly, simultaneously, sequentially, or in staggered fashion to achieve desired production needs, the company reports.
Evonik announced the acquisition of Canada-based Transferra Nanosciences on June 28, 2016. The acquisition will allow Evonik to expand its Business Line Heath Care for parenteral drug delivery technologies and services. Transferra services include prototype identification, scale-up and process development, analytical support and qualification of methods, production of test articles for toxicology studies, and cGMP manufacturing of clinical trial materials (10).
Charles River Laboratories announced on June 27, 2016 that it has acquired Woburn, MA-based Blue Stream Laboratories, an analytical contract research organization supporting the development of complex biologics and biosimilars. This acquisition will combine Blue Stream and Charles River’s existing discovery, safety assessment, and biologics capabilities (11).
Patheon closed an initial public offering of 34 million ordinary shares of its public stock for $21.00 per share on July 26, 2016. According to a statement, the company intends to use the proceeds of the sale and cash on hand to repay its outstanding $550 million of Senior PIK Toggle Notes, and pay related fees, expenses, and accrued interest (12).
EAG, Inc. announced on July 12, 2016, that it has combined its 11 brands under EAG Laboratories to bring together capabilities in the materials, engineering, and life-sciences sectors. The company has 20 locations in the United States, Europe, and Asia-Pacific (13).
In July 2015, the company acquired Analytical Bio-Chemistry Laboratories (ABC Laboratories), and in 2011, acquired Chemir Analytical Services, adding analytical services such as stability programs, extractables and leachables testing, bioanalysis, and custom synthesis.
1. Cambrex, “Cambrex Completes $50 Million Investment in Large Scale API Manufacturing and Storage at Its Charles City, Iowa Site,” Press Release, July 12, 2016.
2. Hovione, “Hovione announces the ground breaking expansion plans of its New Jersey Facility,” Press Release, June 15, 2016.
3. CordenPharma, “CordenPharma Enters Oligonucleotide API Manufacturing Market to Further Strengthen its CDMO Offering,” Press Release, July 1, 2016.
4. CordenPharma, “CordenPharma Caponago Announces Successful Approval of New Sterile Injectable Facility,” Press Release, June 28, 2016.
5. Recipharm, “Recipharm increases blow fill seal capacity in Kaysersberg, France,” Press Release, July 5, 2016.
6. Quay Pharma, “Quay Achieves Successful FDA Inspection,” Press Release, July 19, 2016.
7. Fujifilm, “FUJIFILM Diosynth Announces Collaboration on a New 20,000-Liter Microbial Biologics Facility for Use by Its Contract Development and Manufacturing Customers,” Press Release, June 6, 2016.
8. Fujifilm, “FUJIFILM Diosynth Biotechnologies Opens New Laboratory Facility in Research Triangle Park, NC,” Press Release, May 9, 2016.
9. CMC Biologics, “CMC Biologics Expands GMP Manufacturing Capacity in Europe,” Press Release, June 2, 2016.
10. Evonik, “Evonik acquires Transferra Nanosciences Inc.,” Press Release, June 28, 2016.
11. Charles River, “Charles River Laboratories Acquires Blue Stream Laboratories,” Press Release, June 27, 2016.
12. Patheon, “Patheon N.V. Announces Closing of Initial Public Offering and Full Exercise of Underwriters’ Option to Purchase Additional Shares,” Press Release, July 26, 2016.
13. EAG, “Introducing EAG Laboratories,” Press Release, July 12, 2016.
Pharmaceutical Technology Outsourcing Resources Supplement
When referring to this article, please cite it as “CMOs Invest in Large- and Small-Molecule Manufacturing," Pharmaceutical Technology Outsourcing Resources Supplement 2016.