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A roundup of news from exhibitors at CPhI Worldwide.
Milan, Italy (Oct. 4)-A roundup of news from exhibitors at CPhI Worldwide.
Aesica (Cramlington, UK) recently opened its new pilot plant at Cramlington to manufacture and supply small-scale quantities of clinical compounds (10–100 kg).
Alphora Research (Mississauga, ON, Canada) recently expanded to include a 14,000-ft2 facility to support a new pilot-plant facility. The pilot-plant is currently under construction and is targeted for completion by the end of 2007. This facility includes 200-L and 400-L glass-lined reactors, which includes equipment for cryogenic reactions. Support functions are also being installed, including warehousing and quality control capabilities
Ash Stevens (Detroit, MI) has brought on line a $2 million, 100-L multi-vessel piloting facility. To support development activities, the company invested in two new Rosenmund filter-dryer systems (one for the manufacturing plant and for one the pilot area) to facilitate safe handling of potent compounds and scale-up capabilities. Additional facility upgrades include walk-in refrigerator and freezer units. The company also is investing in additional analytical instrumentation.
BASF (Evans, PA) reports the availability of potassium tert-butylate/2-methyltetrahydrofuran (KTB/2-MeTHF) to the company’s portfolio of alcoholates for drug- and chemical-synthesis applications. The product was featured by the company at CPhI. “Offering KTB in this new solvent gives us the opportunity to offer a number of new benefits to our customers, including the combined advantage of the ‘THF-like’ chemical properties and ‘toluene-like’ physical properties,” said Felix Goerth, global business manager, inorganic specialties for life sciences, for BASF, in a company release. “2-MeTHF has comparable or better chemical properties versus THF. The physical properties of MeTHF allow for better water separations compared to THF, which may lead to a better overall process,” he said. 2-MeTHF is also considered a green alternative because it is obtained from renewable resources and is not soluble in
Carbogen Amcis (Bubendorf, Switzerland) is investing EUR 2.4 million ($3.4 million) to enhance its production and analytics capabilities at its Manchester, England facility. The recently upgraded site features a new pan dryer in production, replacement overheads on reactors, an upgraded steam raising apparatus and a vacuum system. A 2500-L reactor and additional filtration have already been added to the plant. Additional liquid chromatography-mass spectrometry and high-performance liquid chromatography will supplement analytical capabilities by the end of 2007, and later in the year, the laboratory will be rebuilt. The company will also enhance its Bubendorf laboratories by expanding its chromatography services with a new 30-cm column. The new unit will be designed and installed within the CGMP and FDA-inspected manufacturing unit. The company also is adding production time. Its Bubendorf site now operates a 24 hours a day, seven days a week system and operation at the Aarau and Neuland sites in Switzerland has been extended to two shifts.
Catalent Pharma Solutions (Somerset, NJ) will expand its temperature-controlled warehouse in Bolton, United Kingdom, to meet increased customer demand for clinical-supply services, especially cold-chain storage and distribution. This expansion involves a purpose-built extension of the existing facility and is expected to be operational in June 2008. Planned features for the temperature-controlled warehouse include floor space of more than 7500 ft2, more than 2700 controlled ambient storage locations, and a 320-pallet refrigerator.
CMP (Maarssen, Netherlands), the organizers of CPhI Worldwide, announced show dates for regional CPhI events in 2007 and 2008. CPhI India and the introduction of the contract services show ICSE India will be held in Bombay Nov. 25–27, 2007, and the pharmaceutical equipment and machinery show P-MEC India will run November 24–27. Next year will see the launch of a new regional event, CPhI South America and P-MEC South America. The event will be held Aug. 19–21, 2008 in Rio de Janiero, Brazil at the “Cidade Nova” convention complex, which is scheduled to be completed by summer 2008. CMP plans to run the South American installments of CPhI and P-MEC every two years with alternating locations in South America. Next April, CMP will debut P-MEC Japan alongside CPhI Japan, which will be held April 9–11 in Tokyo. CPhI Worldwide for 2008 will be held in Frankfurt, Germany, Sept. 30–Oct. 2.
Hikal (Mumbai, India) has named R. Helmut Rupp as president of its new contract research and development (R&D) company, Hikal Technologies. Hikal Technologies is setting up a new contract R&D facility at Pune, India. The 70,000-ft2 facility will employ approximately 100 scientists in the first phase and serve as a hub for contract research support services. It will provide chemical contract research services for clients in the pharmaceuticals, biotech, and specialty chemical industries.
International Specialty Products (ISP, Wayne, NJ) has named Stuart Porter as senior science fellow to lead new product development and provide technical service support for its “Advantia” Coating Systems. Prior to joining ISP, Porter was working as a consultant for ISP on Advantia. In his new position, Porter will have a primary role in directing ISP’s research teams and developing products for immediate-release and modified-release oral solid-dosage forms. In addition to his R&D role, Dr. Porter will continue to provide technical support to ISP customers.
Lonza (Basel, Switzerland) is launching a molecular-testing method to attain a viable count of microorganisms in as little as four hours using the “microCompass” system. Application laboratories for microCompass are located in Walkersville, Maryland, and Saint Beauzire, France.
The company also recently completed an upgrade of its plant in Kourim, the Czech Republic, to allow for the production of pharmaceutical enzymes. The plant will host the production of Altus Pharmaceuticals’ “ALTU-135” commercial drug-substance enzymes: lipases, proteases and amylases. At the end of last year, Altus awarded Lonza the production of ALTU-135 commercial drug substances.
Novasep (Pompey, France) has installed a second kilo laboratory for highly potent substances synthesis and purification at its facility in Le Mans, France. The company also announced last month that it is finalizing discussions to acquire Bahamas-based PharmaChem Technologies (Grand Bahamas) for an undisclosed amount. PharmaChem's facility, based in Freeport, Bahamas is a CGMP compliant and FDA-inspected plant that manufacturers an antiretroviral active pharmaceutical ingredient.
SAFC (St. Louis, MO) plans to invest $29 million investment to expand its drug- substance capabilities in high-potency biologics at the Sigma-Aldrich facility in Jerusalem, Israel. The site enhancement will enable SAFC Pharma to provide process development and large-scale CGMP manufacturing of high-potency, toxic, or hazardous drug substances. The 50,000-ft2 high-potency fermentation expansion is scheduled for completion in the first quarter of 2009. The expansion will focus production on secondary metabolites (antibiotic-like molecules), cytotoxins, and large-molecule proteins. A 30,000-ft2. area of the new facility has been designed to be Biosafety Level 2 compliant, enabling manipulation of human pathogens. Site capabilities include 1000 and 4000-L tank capacities for bacterial and fungal fermentation.
SAFC is also investing $10 million to increase CGMP commercial-scale active pharmaceutical ingredients (APIs) manufacturing capacity at its SAFC Pharma Arklow, Ireland, facility, and to expand capacity to enhance manufacturing operations at its Buchs, Switzerland facilities. Scheduled for the first quarter of 2008, the $4.7-million Arklow investment will increase production capacity and capability by upgrading the pilot plant and adding additional vessels. SAFC’s Buchs site will extend its existing CGMP production facility with a 17,200-ft2 $5.4 million expansion designed to enhance production capacity by 25% through improved materials flow and separation, and increased materials storage. The new two-level storage facility is expected to become fully operational in spring 2008 and will provide logistical infrastructure to support future expansion. The site supports manufacturing operations for the SAFC Pharma and SAFC Supply Solutions business sectors.
In another investment, Sigma-Aldrich plans to invest in a site at the Wuxi-New District Park (WND) located northwest of Shanghai, China, for its new Asia-Pacific manufacturing hub. Sigma-Aldrich has executed a memorandum of understanding with the WND authorities. The site is to be developed in three phases. Sigma-Aldrich expects to initially invest $25 million to acquire land rights and construct its first-phase that includes a large facility for the SAFC fine-chemical business unit. Sigma-Aldrich plans to begin construction of the new plant by year-end 2007. When fully developed the site is expected to produce raw materials, intermediates, and final products in support of SAFC’s Pharma, Hitech and Supply Solutions businesses through a manufacturing plant, and analytical, packaging and warehousing facilities. Future development phases at the site will also support Sigma-Aldrich’s Research Essentials and Research Specialties business units and include the extension of analytical, packaging and warehousing facilities for its research-based business.