Fine Chemicals: A Roundup of Expansion Activity

Several contract manufacturers of small-molecule active pharmaceutical ingredients (APIs) and intermediates have recently announced or completed expansions. So which companies are making the moves in the fine-chemicals market?

The supply structure of the merchant pharmaceutical fine-chemicals market is highly fragmented. With a diverse and large supplier base, several companies are expanding or adding capabilities. DCAT Value Chain Insights takes an inside look.

A roundup of activity

Alcami. Alcami, a contract development and manufacturing organization (CDMO) for active pharmaceutical ingredients (APIs) and drug products, has launched a Center of Excellence at its API development and manufacturing facility at its site in Germantown, Wisconsin. Previously announced capability extensions in controlled substances and highly potent API (HPAPI) will be serviced by the Center of Excellence. In June 2017, the company received US Drug Enforcement Administration bulk manufacturer registration. HPAPI capability implementation is in its final phase with two cGMP production suites equipped with engineering controls designed to meet the established occupational exposure limit of minimally 0.03 micrograms per cubic meter. The company initiated process development for its first HPAPI program in the second quarter of 2017 and plans to begin manufacturing in the fourth quarter of 2017 with a pipeline of programs to follow.

AMRI. In September 2017, Albany Molecular Research Inc. (AMRI), a contract research, development and manufacturing organization, completed its previously announced acquisition by affiliates of The Carlyle Group and affiliates of GTCR LLC, two investment firms. AMRI had announced the acquisition in June 2017. With the move, AMRI, formerly a publicly traded company, will go private. President and Chief Executive Officer William S. Marth will continue to lead AMRI. AMRI recorded contract revenues of $560.43 million in 2016. The company has four business segments: drug-discovery services, active pharmaceutical ingredients, drug products, and fine chemicals.

Cambrex. Cambrex, a contract manufacturer of small-molecule APIs, is investing $24 million in a new facility to manufacture highly potent APIs at its site in Charles City, Iowa. The 4,500-square-foot production area will operate to an occupational exposure limit down to 0.1 micrograms per cubic meter and have a total reactor capacity of 2,200 gallons. The reactors will be made up from a range of 200-, 500-, and 1,000-gallon glass and Hastelloy vessels to manufacture batches from 50 to 300 kg. The project will reconfigure the existing small-scale manufacturing area providing a single high-containment building to support early-stage development and manufacturing. Construction and installation of all new equipment is expected to be completed by the first quarter of 2019.

The expansion is part of an ongoing strategic campaign by Cambrex to invest in small-molecule API development and manufacturing across its facilities and follows the opening of a $50-million, 7,500-square-foot multi-purpose manufacturing facility at Charles City in 2016, which added a total of 70 cubic meters of manufacturing capacity to the site.

The company also expanded its large-scale manufacturing capacity at its cGMP facility in Karlskoga, Sweden and introduced additional continuous flow manufacturing for the production of high-purity intermediates. The expansion includes the installation of new multi-purpose reactors ranging from 4 cubic meters to 12 cubic meters and upgrading of the control room within an existing plant on site. This extra capacity increases the large-scale manufacturing capabilities of the Karlskoga facility, which supports clients’ development projects from R&D through to large-scale commercial manufacturing. Installation of all new equipment, including a 9-cubic-meter hydrogenation reactor, was scheduled to be completed by the third quarter of 2017. In addition to the capacity investment at the Karlskoga site, Cambrex has introduced a dedicated continuous flow production unit, capable of producing multiple metric tons of high-purity intermediates per annum.

The company is also investing $3.2 million to expand its facility in High Point, North Carolina with the addition of an 11,000-square-foot-analytical laboratory. Installation of equipment, including high-performance liquid chromatography, mass spectrometers, and support equipment. The expansion will commence in the third quarter of 2017, with validation and start-up anticipated in the fourth quarter of 2017. Cambrex acquired the 35,000-square-foot High Point site, formerly part of PharmaCore, in October 2016. At the North Carolina facility, Cambrex produces APIs and intermediates requiring multi-step synthetic processes in batch sizes from milligrams to 100 kg to support clinical trials from Phase I to Phase III. The site is licensed with the US Drug Enforcement Administration to manufacture Schedule II to Schedule V controlled substances.

In May 2017,  Cambrex announced that it is expanding pilot-plant capabilities at its High Point, NC facility with the installation of a fourth reactor suite. The $2.4-million investment will increase the site’s reactor capacity by around 30% and is expected to be fully operational by early 2018.

Flamma. Flamma SpA, an Italy-headquartered contract manufacturer of small-molecule APIs opened its new cGMP workshop and Research and Development (R&D) Center in Dalian, China in June 2017. The investment of $20 million brings the total capacity of Flamma’s Chinese operations in Dalian to 200 cubic meters and brings its R&D group to the same campus for increased efficiency and productivity. The company has other expansions underway. By 2018, Flamma intends to spend $5 million to expand its R&D capabilities with the addition of a new R&D building at its headquarters in Chignolo d’Isola, Italy. By 2020, Flamma plans to increase its production capacity by 40% with the addition of another cGMP workshop at its Chignolo d’Isola headquarters.

Granules India. Earlier this year, Granules India Limited, a Hyderabad, India-based pharmaceutical manufacturing company, received approval for $47.5 million in funding from the International Finance Corporation (IFC), a member of the World Bank Group, for expansion projects, including construction of a new greenfield API facility in Vishakhapatnam, India.

Johnson Matthey. In September 2017, Johnson Matthey (JM) and Snapdragon Chemistry, a Cambridge, Massachusetts-headquartered provider of flow-chemistry process design and technology development services, formed a collaboration to provide integrated continuous manufacturing services for flow chemistry from development to full-scale good manufacturing practice (GMP) manufacturing. The collaboration is designed to enable an end-to-end offering that can provide process development and manufacturing services from flow-chemistry route conception to GMP bulk production. The agreement combines Snapdragon Chemistry’s flow chemistry design, development, and characterization capabilities with JM’s offering in clinical to commercial active pharmaceutical ingredient development and manufacturing, which includes quality systems infrastructure, together with JM’s experience in continuous manufacturing processes.

Neuland Laboratories. In July 2017, Neuland Laboratories, a Hyderabad, India-based contract manufacturer of APIs and intermediates, brought on line a process engineering lab at its research and development center to support operations and safety studies using a quality-by-design (QbD) approach in drug substances’ development. The lab includes a stirred, controlled HEL reaction calorimeter that measures the rate of heat release during reactions. Automated parallel HEL reactors enable a chemist to perform multiple experiments at temperatures ranging from -60 to 225 degrees Celsius. The lab’s new thermal screening unit indicates the thermal stability of chemicals and safe processing temperatures.

Nitto Denko Avecia. Nitto Denko Avecia, a manufacturer of industrial and life-science products, opened a new oligonucleotide active pharmaceutical ingredients manufacturing facility in Milford, Massachusetts in August 2017. The expansion added 20,000 square feet of manufacturing and office space at the Milford site to provide cGMP oligonucleotide manufacturing capacity up to 1.8 mol. The total capacity at the Milford site will more than double up to 3.0 mol.

Novasep. Earlier this year Novasep, a Lyon, France-headquartered contract manuacturing organization, opened a new EUR 11-million ($11.6-million) bioconjugation facility at its site in Le Mans, France, for clinical and commercial manufacturing of antibody-drug conjugates (ADCs). The new facility completes Novasep’s ADC manufacturing platform, which includes ADC payloads, drug linkers, and monoclonal antibody commercial-scale production capabilities.

Olon. In June 2017,Olon S.p.A., an Italy-headquartered contract development and manufacturing organization of active pharmaceutical ingredients and generics supplier, acquired the Chemical Division of Concord, Ohio-based Ricerca Biosciences, a contract research organization and CDMO. In 2016, Olon acquired Infa, an Italy-based contract manufacturer of APIs and intermediates. The acquisition of Ricerca provides Olon with US-based manufacturing. With the acquisition of Infa, Olon gained additional manufacturing sites bringing Olon’s manufacturing sites to eight European production sites (Rodano, Settimo Torinese, Garbagnate Milanese, Mulazzano, Dorno, Segrate, and Lodi in Italy and one site in Murcia, Spain).

Patheon. Patheon, which was acquired by Thermo Fisher Scientific for $7.2 billion in August 2017, added to its small-molecule development and manufacturing capabilities by acquiring Roche’s API manufacturing facility in Florence, South Carolina, in a deal that Patheon had first announced in November 2016. The Florence site adds a 300,000 square-foot facility with manufacturing capacity for APIs ranging from development to commercial manufacturing. The addition of this site expands Patheon’s capacity for manufacturing highly potent compounds and adds capabilities to support solid-state chemistry, micronization (small and large), and future commercial spray drying. The site serve as Patheon’s flagship US API operation for commercial-scale and mid-scale API production.

Piramal Pharma Solutions. Piramal Pharma Solutions (PPS) is investing $55 million across its sites in North America and Asia to expand its API manufacturing capabilities and capacities. A part of this investment will go into new multi-purpose plants, with over 270 kilo liters of total capacity, to support PPS’ pipeline of approximately 80 late-stage programs. PPS will also expand its plant in Riverview, Michigan while augmenting its early-development capabilities at its facility in Ennore, India through additions of GMP kilo labs and a pilot plant. PPS will add early-development capabilities in both drug substance and drug product out of its Morpeth, UK facility. Support functions such as analytical capabilities, research and development infrastructure, automation, and IT systems will also be expanded at all API sites through this investment.

PPS supports API development and manufacturing through an integrated model across its five sites in North America, Europe, and Asia. API development activities, including route scouting and process development, are conducted at the company’s facilities in Riverview, Ennore and Aurora, California. These facilities are forward integrated with commercial API manufacturing units at Aurora, Ennore, Riverview, Morpeth, and Digwal, India.

STA Pharmaceutical. STA Pharmaceutical Co., part of WuXi AppTec’s Pharmaceutical Development Services Division, is expanding its new integrated R&D and commercial site in Changzhou, China in stages. On completion, the Changzhou site will include 500 scientists and more than 1,000 cubic meters of reactor volume.

The company recently added a new pilot plant and 200 new process R&D scientists. The new pilot plant started operation in November 2016 with 40 reactors ranging from 250 liters to 5,000 liters. In addition, a second commercial plant will be installed in 2017, nearly doubling reactor volume in Changzhou to 490 cubic meters. As of January 2017, Changzhou had 60 reactors with a total reactor volume of 290 cubic meters. The first commercial plant opened a year ago with a milling system recently installed. The Changzhou site, which was officially opened in March 2016, has grown to over 200 scientific personnel including 160 process chemists, 40 analytical chemists, and a specialist group of crystallization technology engineers trained for over a year at the company’s Shanghai R&D facility. The 10,000-square-meter R&D center currently has 24 process chemistry laboratories and a process safety lab. Another 24 process chemistry labs as well as a catalysis center will be added in Changzhou by the end of 2017. STA plans to have approximately 300 scientists in its R&D teams, consisting of 230+ process chemists and 70 analytical chemists, by the end of 2017 with a focus on antibody drug conjugates and high potent research projects. The Changzhou site has approximately 60 active pharmaceutical ingredients and/or intermediates under development and one new chemical entity in commercial production.

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