Inside INFORMEX: Evaluating the Market for Contract API Manufacturing

Contract API manufacturers and fine-chemical producers roll out capacity and service expansions.
Apr 02, 2012
Volume 36, Issue 4

Patricia Van Arnum
Contract API manufacturers and fine-chemical producers gathered at Informex, the annual trade show of custom and batch manufacturers, in New Orleans in February. Companies used the show to highlight recent capacity and service expansions as well acquisitions. These investments reflect targeted moves to increase capacity in specialized areas, such as high-potency manufacturing, diversification into non-API areas, such as formulation development, finished product manufacturing, and testing, as well as partnering with other providers to broaden service offerings and capabilities.

Capacity expansions

High-potency. Several CMOs highlighted recent expansions in high-potency manufacturing. Aesica opened a new purpose-built $4.6-million high-potency manufacturing facility for the manufacture of formulated products and plans to upgrade its API manufacturing facilities to enable manufacture of high-potency APIs at commercial scale. The upgrade will allow Aesica to manufacture SafeBridge Category 3 APIs and formulated products from pilot to commercial scale from two of its sites in Europe. The new facilities will enable Aesica to manage high-potency API production at quantities from 1–200 kg. Further investment in API manufacturing capability in 2013 will equip Aesica to produce batch sizes up to 600 kg.

Helsinn Advanced Synthesis reported on its cytotoxic and high-potency manufacturing facilities in Biasca, Switzerland, and multiyear expansions in this area. The company's capabilities include pilot-scale, small-scale, and commercial-scale capabilities for manufacturing highly potent APIs. Its cytotoxic capabilities include isolated and dedicated cytotoxic quality control and R&D laboratories, raw-materials and finished-goods warehousing, and finishing and sampling areas. A new laboratory has been constructed exclusively for small-scale cytotoxic production, design of experiment, and initial process development. The company also has pilot-scale, small-scale, and commercial-scale capabilities for manufacturing cytotoxic small molecules.

Evonik recently opened a new laboratory at its site in Hanau, Germany, for highly potent APIs and expanded its cGMP capacity for highly potent APIs on a kilogram scale at its Tippecanoe facility in Lafayette, Indiana. The new laboratory allows Evonik to develop and optimize syntheses for highly potent APIs in Germany. At the US site, Evonik has similar laboratory installations, expanding capacity with a reactor volume for highly potent compounds totaling 170 m3.

Fermion has invested in a new high-potency facility capable of handling OEL Class V compounds. The company added 10 m3 of additional high-potency manufacturing capacity with reactors ranging in volume from 70 L to 1500 L. The construction of this facility began in mid-2011 and the finished plant was scheduled to come on line in March 2012. By the fall of 2012, additional improvements will allow hydrogenation reactions to be undertaken at the facility.

Other expansions. Almac is doubling analytical capacity at its 240,000-ft2 North American headquarters in Souderton, Pennsylvania. The facility offers full-service, integrated clinical packaging, drug-supply management, and technology services to pharmaceutical and biotechnology clients. Almac's additional laboratory investment will include polymorph and salt screening and solid-form development. The new facility is also equipped with a bathless dissolution apparatus for comparative dissolution studies.

In addition to API and chemical development services, Almac provides formulation development and solid-dosage manufacturing for clinical-trial materials and commercial manufacturing and related services. The company recently acquired two new pieces of encapsulation equipment for its North American headquarters in Souderton, Pennsylvania: the Bosch GKF 702 capsule filler with integrated KKE 1700 checkweigher. The Bosch cGMP-compliant system is able to produce 42,000 capsules per hour compared to the 2700–4500 output of Almac's current machine in the United States. Further capabilities of the new equipment include powder, pellet, tablet, and placebo fill as well as multifill.

Asymchem Laboratories (Tianjin) reported on the opening its new large-scale manufacturing facility, Jilin Asymchem Laboratories, in Dunhua, Jilin province, China. Phase I completion of Dunhua's manufacturing facility included 5000–20,000 L vessels for cGMP manufacture of raw materials to intermediates. Phase II involved completion of a second module for a total capacity of 532 m3. This site offers manufacturing as a standalone service and also back-integration for internal downstream cGMP targets to be further processed in Asymchem's Tianjin 2 GMP facility. Phase III construction in Dunhua for a GMP API manufacturing plant is on schedule and is expected to be completed later this year.

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